TaKeTiNa Music Therapy for Outpatient Treatment of Depression: Study Protocol for a Randomized Clinical Trial.

BACKGROUND/OBJECTIVES: Depression is a prevalent and debilitating illness that significantly affects psychological and physical well-being. Apart from conventional therapies such as psychotherapy and medication, individuals with depression often lack opportunities for activities that are generally perceived as enjoyable, such as music, meditation, and arts, which have demonstrated therapeutic effectiveness. TaKeTiNa music therapy has been employed as a therapeutic intervention for more than two decades. However, there is a notable absence of well-designed clinical trials investigating its antidepressant effects, a gap we aim to address in our current study. Furthermore, shifts in the progression of depression may manifest both psychologically, by influencing emotional states, and physiologically, by leading to alterations in lipid and sphingolipid metabolism, cortisol levels, and immune system function. Our study seeks to analyze the impact of TaKeTiNa music therapy on both levels. METHODS: This is a prospective monocentric randomized waitlist-controlled clinical trial. It investigates the influence of TaKeTiNa music therapy on patients with major depression in an outpatient setting. Therefore, interested persons are randomly assigned to two groups, an intervention group or a control group, after completing a screening procedure. The intervention group starts with an eight-week TaKeTiNa music therapy intervention. The waiting group receives the same therapy program after completing the follow-up period. Blood and saliva sampling as well as responses to questionnaires are obtained at specific time points. DISCUSSION: Our study investigates the effects of TaKeTiNa music therapy, a non-pharmacological antidepressant treatment option, on depressive symptoms. We also address functional and causal immunological changes; hormonal changes, such as changes in cortisol levels; and metabolic changes, such as changes in serum lipids and sphingolipids, during the course of depression. We expect that this study will provide evidence to expand the range of treatment options available for depression.

[The Effect of Exercise Therapy on Adolescent Mental Health: A Systematic Review with Practical Example]. / Wirkung von Sportinterventionen auf die psychische Gesundheit von Jugendlichen: Ein systematisches Review mit Praxisbeispiel Boulderpsychotherapie.

The Effect of Exercise Therapy on Adolescent Mental Health: A Systematic Review with Practical Example Abstract: The mental health of children and adolescents in Germany is currently highly burdened. Because of the psychotherapeutic care situation, easily accessible, less stigmatizing, and efficient offers are urgently needed. Exercise therapy would be one possibility. However, the effectiveness of such offers must first be proven. We conducted a systematic review concerning the effectiveness of exercise therapy on the mental health of children and adolescents which included studies since 2020 (subsequent to Hale et al., 2021). We analyzed a total of 17 intervention studies based on the PRISMA statement. The results show that exercise therapy interventions significantly affect certain populations: Attention and cognitive skills significantly improved in children and adolescents with ADHD; for depression, we found positive effects for affection. Some studies revealed significant effects across populations on the quality of life and sleep. In children and adolescents with autism or learning disabilities, we found positive effects on social behavior. Thus, according to the literature, exercise therapy is a recommendable therapy option for children and adolescents with mental health problems. As an illustration, we present a boulder intervention as a combined exercise intervention and psychotherapy along with its feasibility as a possible practical example.

New ways to cope with depression-study protocol for a randomized controlled mixed methods trial of bouldering psychotherapy (BPT) and mental model therapy (MMT).

BACKGROUND: Due to the growing gap between the demand and supply of therapeutic services for people suffering from depression, with this study, we are investigating the effectiveness and factors of influence of new approaches in group treatments for depression. Two previous studies have already identified bouldering psychotherapy (BPT) as an effective option. It combines psychotherapeutic interventions with action- and body-oriented bouldering exercises. Mental model therapy (MMT) is a new cognitive-behavioral approach for treating depression. It focuses on identifying cognitive distortions, biases in decision making, and false assumptions and aims to correct and replace them with useful mental models. We aim to investigate the effectiveness of the interventions compared with a control group (CG) and to assess the factors of influence in a mixed methods approach. METHODS: The study is being conducted as a randomized controlled intervention trial. Adult participants with unipolar depression are being randomized into three groups (BPT, MMT, or CG), and the first two groups are undergoing a 10-week treatment phase. CG follows their individual standard treatment as usual. A priori power analysis revealed that about 120 people should be included to capture a moderate effect. The primary outcome of the study is depression rated with the Montgomery and Asberg Depression Rating Scale (MADRS) before (t0), directly after (t1), and 12 months after the intervention phase (t2). Data are being collected via questionnaires, computer-assisted video interviews, and physical examinations. The primary hypotheses will be statistically analyzed by mixed model ANOVAs to compare the three groups over time. For secondary outcomes, further multivariate methods (e.g., mixed model ANOVAs and regression analyses) will be conducted. Qualitative data will be evaluated on the basis of the qualitative thematic analysis. DISCUSSION: This study is investigating psychological and physical effects of BPT and MMT and its factors of influence on outpatients suffering from depression compared with a CG in a highly naturalistic design. The study could therefore provide insight into the modes of action of group therapy for depression and help to establish new short-term group treatments. Methodological limitations of the study might be the clinical heterogeneity of the sample and confounding effects due to simultaneous individual psychotherapy. TRIAL REGISTRATION: ISRCTN, ISRCTN12347878. Registered 28 March 2022, https://www.isrctn.com/ISRCTN12347878 .

Treating depression in an outpatient setting: Predictors of patient response to bouldering psychotherapy, cognitive behavioural therapy or exercise alone.

BACKGROUND: Bouldering psychotherapy (BPT) for depression has proven effective, but nothing is known about its potential predictors of response. This study should identify predictors of response to BPT, cognitive behavioural therapy (CBT) and an active control (home-based exercise programme; EP) using a literature-based model. METHODS: In a multicentre randomised controlled trial, 233 outpatients were assigned to BPT, CBT or EP. Response (reduction of at least 46% on the Montgomery-Åsberg Depression Rating Scale [MADRS]) and remission (≤7 MADRS points) were defined as suggested by the literature. Predictors of response were identified twofold: (1) univariate analyses followed by logistic regression analyses in each group with all predictors yielding a univariate p-value <.20 and (2) a backward regression analysis with all potential predictors. Only variables that emerged as predictors in both types of analyses were interpreted. RESULTS: There was a significantly greater proportion of responders (p = .035) in the BPT than in the EP. The chance of response in the BPT was higher for patients with a higher health-related quality of life. In the EP, response was higher for patients with lower interpersonal sensitivity, suffering from their first episode and living with a partner. CONCLUSIONS: Response rates in BPT are similar to or even higher than in other outpatient psychotherapy group therapies. BPT and CBT are suitable for a wide range of patients, but patients with higher functionality could start with psychoeducation and exercise.

A Climbing (Bouldering) Intervention to Increase the Psychological Well-Being of Adolescents in the Bekaa Valley in Lebanon-Study Protocol for a Controlled Trial.

(1) Background: Adolescent refugees in Lebanon and Lebanese youth are both at high risk of suffering from reduced psychological well-being. Sport is an evidence-based strategy for improving mental and physical health, and climbing is a type of sport that may positively impact both. The aim of this study is to test the effect of a manualized, psychosocial group climbing intervention on the well-being, distress, self-efficacy, and social cohesion of adolescents in Lebanon. In addition, the mechanisms behind psychological changes will be investigated. (2) Methods: In this mixed-methods waitlist-controlled study, we are allocating a minimum of 160 participants to an intervention (IG) or a control group (CG). The primary outcome is overall mental well-being (WEMWBS) after the 8-week intervention. Secondary outcomes include distress symptoms (K-6 Distress Scale), self-efficacy (General Self-Efficacy Scale; GSE), and social cohesion. Potential mechanisms of change and implementation factors are being investigated through qualitative interviews with a subgroup of 40 IG participants. (3) Conclusions: The results may contribute to knowledge of sports interventions and their effects on psychological well-being and will provide insights regarding low-intensity interventions for supporting adolescent refugees and host populations in conflict-affected settings. The study was prospectively registered at the ISRCTN platform (current-controlled trials). ISRCTN13005983.

Predictors of falls and hospital admissions in people with cognitive impairment in day-care: role of multimorbidity, polypharmacy, and potentially inappropriate medication.

BACKGROUND: Multimorbidity, polypharmacy, and potentially inappropriate medication (PIM) pose challenges for the care of people with cognitive impairment. The aim of the present study is to explore whether multimorbidity, polypharmacy, and PIM predict falls and hospital admissions in a sample of people with cognitive impairment in day-care centers in Germany. METHODS: We used data from the German day-care study (multicenter longitudinal study, n = 433). Multimorbidity was defined as ≥ 2 chronic diseases. Polypharmacy was defined as prescriptions to ≥ 5 drugs. Potentially inappropriate medication was defined as scoring on the PRISCUS list. Binary logistic regression analyses were computed to determine whether multimorbidity, polypharmacy, and potentially inappropriate medication at t0 predicted falls and hospital admissions as outcomes at t1 (six months later). RESULTS: The rate of multimorbidity and polypharmacy was 87.8% and 60.3%, respectively. 15.9% of the people with cognitive impairment received PIM / PRISCUS-listed drugs, 43.6% ACB-listed drugs, and 52.7% CNS depressant drugs. Falls and hospital admissions during follow-up were prevalent in 19.4% and 24.7% of the people with cognitive impairment. Both were significantly predicted by the total number of drugs (falls: OR = 1.152, p = 0.001, overall model: p < 0.001; hospital admissions: OR = 1.103, p = 0.020, overall model: p = 0.001), even if regression analyses were controlled for the number of comorbidities. CONCLUSIONS: Polypharmacy and potentially inappropriate medication are highly prevalent in people with cognitive impairment in German day-care centers. The number of drugs and appropriateness of medication seem to be crucial for the risk of falls and hospital admissions. Polypharmacy and PIM should be critically reviewed by healthcare providers and avoided as much as and whenever possible. TRIAL REGISTRATION: ISRCTN16412551, 30 July 2014, registered partly retrospectively.

Chronic headache patients' health behavior and health service use 12 months after interdisciplinary treatment - what do they keep in their daily routines?

BACKGROUND: We do not yet know whether or the extent to which multimodal therapy changes the health behaviors and health service use of chronic headache patients in the long term. Associations are expected between pain symptoms and pain management abilities for patients who are categorized as successfully treated and those who remain unchanged. METHODS: Routine longitudinal data of an enrolment period of five years from 101 headache patients treated with a two-week, full-day, semi-inpatient multimodal pain therapy at the Interdisciplinary Pain Center of the University Clinic Erlangen were available when therapy began and 12 months after treatment. To investigate long-term changes in health behavior and health service use as well as their associations with the outcome "reduction in pain days," we used descriptive and inferential statistics (i.e., binary logistic regression). RESULTS: Patients who underwent interdisciplinary treatment showed statistically significant changes in their health behavior in five areas. Twelve months after treatment, we found a significantly higher frequency of engagement in athletic sports (p < .001) as well as increases in the use of relaxation techniques (p < .001), TENS devices for relaxation purposes (p = .008), psychological coping strategies (p < .001), and mindfulness-based techniques for dealing with pain (p < .001). 52.8% of the sample reported a reduction in the number of pain days 12 months after treatment. Binary logistic regression (χ2 (12) = 21.419; p = .045; R2 = .255) revealed that a reduction in pain days 12 months after treatment was positively associated with regular physical activity in the form of muscle strengthening and stretching (athletic sports) (p = .012). CONCLUSION: Chronic headache patients acquired long-term skills from an interdisciplinary treatment concerning the use of relaxation techniques, the use of psychological coping strategies, and physical activity in the form of athletic exercise. Of those, regular athletic exercise was positively associated with a smaller number of pain days in the long term. Thus, a physical activity module should be an element of interdisciplinary treatment for chronic headache patients.

[Predictors of intensity of use of adult day care centers in people with cognitive impairment]. / Prädiktoren für die Nutzungsintensität von Tagespflegen bei Menschen mit kognitiven Einschränkungen.

BACKGROUND: Adult day care is an established concept in Germany for people with cognitive impairment; however, only a small fraction of people in need for care actually use adult day care. Studies so far highlighted some predictors for the use of adult day care; however, it remains unclear which factors are associated with the intensity of use. OBJECTIVE: To identify relevant predictors for the intensity of use of adult day care using the Andersen healthcare utilization model. MATERIAL AND METHODS: Data used were obtained within the project dementia in day care with psychosocial MAKS interventions (DeTaMAKS), which studied adult day care users with cognitive impairments and their family caregivers. A logistic regression was performed to predict frequent or low use of adult day care. RESULTS: The following factors were significantly associated with higher intensity of use: civil status of adult care user being widowed or single, higher educational level of caregiver, higher care level, longer duration of adult day care use and more mental and behavioral symptoms of the adult day care user. The sensitivity analysis for cohabiting dyads additionally showed a higher intensity of use with a lower age of the caregiver and shorter distance between place of residence and adult day care but not with respect to educational level of the caregiver and mental and behavioral symptoms of the user. CONCLUSION: The results show a need for adult day care, which increases with caregivers being employed and users living outside of permanent relationships. A short distance to the adult care center as well as flexible care options may increase the frequency of use.

[Implementation and Effect of the Multimodal Psychosocial MAKS Intervention in Day Care Centers for People with Cognitive Impairment: Follow-up Results After the End of the RCT]. / Implementierung und Wirkung der multimodalen psychosozialen MAKS-Intervention in der Tagespflege bei Menschen mit kognitiven Beeinträchtigungen: Ergebnisse in der offenen Phase nach Beendigung des RCT.

AIM OF THE STUDY: Study of the long-term effects of a psychosocial intervention in dementia including its implementation under real world conditions in day care centers. In the present study this was investigated for the MAKS intervention - Motor, Activities of daily living, (K)Cognitive and Social-communicative component. METHODS: At the end of a 6-month, cluster-randomised, controlled study, professional caregivers in all 32 day care centers (DCC) were trained in MAKS. From then on, all centers were free to carry out the intervention or not (open phase). In the 18-month follow-up phase, after 6 and 18 months the heads of the DCC were asked whether MAKS was carried out regularly in the trained form. After 6 months in the open phase, the cognitive abilities of the study participants with mild cognitive impairment, mild to moderate dementia were again assessed using Mini-Mental Status Examination (MMSE). Multiple linear regression analysis was used to investigate whether the MMSE score was predicted by carrying out MAKS or not. Other adjustment variables were MMST score at t6, age, sex, frequency of visits to TP, antidementia medication use, and depressiveness. RESULTS: In the first 6 months of the open phase, 22 DCC (69%) stated that they performed MAKS. In months 7 to 18, this proportion increased up to 81%. For the 287 study participants in the 32 DCC, the fact whether they were guests in a DCC with or without MAKS was a significant predictor of the course of cognitive abilities (p=0.019). The average MMSE score in DCC without MAKS decreased; in DCC with MAKS it stayed approximately the same. Other significant predictors were baseline score and use of antidementia medications (individuals on antidementia medications scored worse). CONCLUSION: The multimodal, psychosocial MAKS intervention for people with cognitive impairment that has been trained in a structured way can be implemented in day care centers on a long-term basis. MAKS has a positive effect on cognitive abilities also in a real world scenario.

Bouldering psychotherapy is not inferior to cognitive behavioural therapy in the group treatment of depression: A randomized controlled trial.

OBJECTIVES: Bouldering has shown promising results in the treatment of various health problems. In previous research, bouldering psychotherapy (BPT) was shown to be superior to a waitlist control group and to physical exercise with regard to reducing symptoms of depression. The primary aim of this study was to compare group BPT with group cognitive behavioural psychotherapy (CBT) to test the hypothesis that BPT would be equally as effective as CBT. DESIGN: We conducted a randomized, controlled, assessor-blinded non-inferiority trial in which 156 outpatients meeting the criteria of a depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) were randomly assigned to one of the two intervention groups (CBT: N = 77, BPT: N = 79). METHODS: Intervention groups were manualized and treated for 10 weeks with a maximum of 11 participants and two therapists. The primary outcome was depressive symptom severity assessed with the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Patient Health questionnaire (PHQ-9) at the beginning and end of the treatment phase as well as one year after the end of treatment. RESULT: In both groups, depressive symptoms improved significantly by an average of one severity level, moving from moderate to mild depressive symptoms after therapy (MADRS difference scores: BPT -8.06, 95% CI [-10.85, -5.27], p < .001; CBT -5.99, 95% CI [-8.55, -3.44], p < .001). The non-inferiority of BPT in comparison with CBT was established on the basis of the lower bound of the 95% confidence interval falling above all of the predefined margins. BPT was found to be effective in both the short (d = 0.89) and long term (d = 1.15). CONCLUSION: Group BPT was found to be equally as effective as group CBT. Positive effects were maintained until at least 12 months after the end of therapy. Thus, BPT is a promising approach for broadening the therapeutic field of therapies for depression. PRACTITIONER POINTS: Physical activity is effective in the treatment of depression and current guidelines explicitly recommend it as a complementary method for the treatment of depression. Nevertheless, body-related interventions are still underrepresented in current treatments for depression. Bouldering psychotherapy (BPT) combines physical activity with psychotherapeutic content. Its concept relies on proven effective factors from CBT such as exposure training, problem solving and practicing new functional behaviours and is thus an enrichment and implementation of CBT methods on the bouldering wall. The positive effect of group bouldering psychotherapy (BPT) in reducing depressive symptoms in outpatients with depression is not inferior to the effect of group cognitive behavioural therapy (CBT). Additionally the 10-weeks BPT-programme significantly improved symptoms of anxiety and interpersonal sensitivity as well as health-related quality of life, coping, body image, self-efficacy, and global self-esteem.

Is bouldering-psychotherapy a cost-effective way to treat depression when compared to group cognitive behavioral therapy - results from a randomized controlled trial.

BACKGROUND: Bouldering-Psychotherapy (BPT) has proven to effectively reduce depressive symptoms, but evidence on its cost-effectiveness is lacking. Corresponding information is paramount to support health policy decision making on a potential implementation of BPT in routine care. METHODS: Using data from the German KuS trial BPT was compared with group Cognitive Behavioral Therapy (CBT). Severity of depression symptoms at end of the intervention was operationalized via Montgomery-Asberg Depression Rating Scale (MADRS) and Patient Health Questionnaire (PHQ-9). Adopting a societal perspective, direct medical costs and productivity loss were calculated based on standardized unit costs. To determine incremental cost-effectiveness ratios (ICER) and cost-effectiveness-acceptance curves (CEAC), adjusted mean differences (AMD) in costs (gamma-distributed model) and both effect parameters (Gaussian-distributed model) were obtained from 1000 simultaneous bootstrap replications. RESULTS: BPT was related to improved effects (AMDs: MADRS -2.58; PHQ-9: - 1.35) at higher costs (AMD: +€ 754). No AMD was significant. ICERs amounted to €288 per MADRS-point and €550 per PHQ-9-point. For both effect parameters about 20% of bootstrap replications indicated dominance of BPT, and about 75% larger effects at higher costs. At hypothetical willingness to pay (WTP) thresholds of €241 (MADRS) and €615 (PHQ-9) per unit of change BPT had a 50% probability of being cost-effective. CONCLUSION: BPT is a promising alternate treatment strategy which - in absence of established WTP thresholds for improving symptoms of depression - cannot unambiguously be claimed cost-effective. Further studies defining subgroups that particularly benefit from BPT appear paramount to delineate recommendations for an efficient prospective roll-out to routine care.

Predictors of institutionalization in users of day care facilities with mild cognitive impairment to moderate dementia.

BACKGROUND: Most people with dementia wish to remain at home for as long as possible. Therefore, it is important to know the predictors of institutionalization, especially those that can be influenced. The aim of the present study is to identify predictors of the institutionalization of people with mild cognitive impairment (MCI) to moderate dementia who attend day care facilities (DCFs) throughout Germany. METHODS: This study is a secondary analysis of longitudinal data from 371 dyads comprising a cognitively impaired care receiver (CR) and a caregiver (CG). The data were collected in DCFs and via telephone interviews at three measurement points. To investigate the extent to which 16 variables could predict the institutionalization of the CRs between the 6- and 12-month follow-up, in the first step bivariate Cox regressions were calculated. In the second step, significant predictors were included in a model using multivariate Cox regression. RESULTS: Between the 6- and 12-month evaluations, 39 CRs moved into an institution. The risk of institutionalization of people with MCI to moderate dementia attending a DCF increased significantly (p < .05) when the CRs showed more neuropsychiatric symptoms (Hazard ratio (HR) = 1.237), when the CRs and their CGs did not live together in the same house (HR = 2.560), or when the care level of the CRs is low (HR = 2.241). CONCLUSIONS: Neuropsychiatric symptoms could be a possible starting point for therapeutic interventions that are designed to delay or prevent institutionalization. CG who do not live with their CR in the same house and CG who care for a CR with impairment in performing daily routine tasks care are particularly likely to make the decision to institutionalize the CR. For this group, advice and support are particularly important. TRAIL REGISTRATION: ISRCTN16412551 .

Bouldering psychotherapy is effective in enhancing perceived self-efficacy in people with depression: results from a multicenter randomized controlled trial.

BACKGROUND: Recent studies have suggested that therapeutic climbing/bouldering may have positive effects on perceived self-efficacy. Nevertheless, there is still an urgent need for high-quality studies, as many existing studies have suffered from methodological problems. Therefore, the current work was aimed at investigating the effect of a manualized bouldering psychotherapy (BPT) on perceived self-efficacy in people with depression, compared with a home-based physical exercise program (EP) and state-of-the-art cognitive behavioral group therapy (CBT). METHODS: In a prospective, multicenter, randomized controlled trial, 233 people with depression were randomly assigned to one group (BPT, EP, or CBT). Perceived self-efficacy was assessed at baseline (t0) and directly after the 10-week intervention period (t1) with the GSE. In addition, depression was assessed with the PHQ-9 and the MADRS. We computed t tests, analyses of variance (ANOVAs), confounder-adjusted hierarchical regression analyses, mediation analyses, and several sensitivity analyses. RESULTS: BPT participants showed a significantly larger increase in perceived self-efficacy on the GSE compared with the EP (an increase of 3.04 vs. 1.26 points, p = .016, Cohen's d = 0.39). In the confounder-adjusted hierarchical multiple regression analysis, group allocation (BPT vs. EP) was found to be the only significant predictor of the postintervention GSE score (ß = .16, p = .014) besides the baseline GSE score (ß = .69, p < .001). No differences were found between BPT and CBT participants regarding the effect on perceived self-efficacy. Only in the CBT group, the relationship between depression at baseline and postintervention was partially mediated (23%) by perceived self-efficacy. CONCLUSIONS: Participation in the manualized BPT in a group setting leads to a clinically relevant enhancement of perceived self-efficacy in people with depression. This effect is superior to that of physical exercise alone. The results provide also initial indications that BPT is comparable to CBT in enhancing perceived self-efficacy, suggesting a strong case for a broader use of BPT as a supplement to existing health services. Future studies should focus on the modes of action of BPT and its effect on perceived self-efficacy in people with other mental or physical disorders. Trial registration ISRCTN12457760, registered partly retrospectively, 26 July 2017.

Bouldering psychotherapy is more effective in the treatment of depression than physical exercise alone: results of a multicentre randomised controlled intervention study.

BACKGROUND: Recent scientific studies have suggested that climbing/bouldering is effective in alleviating depression when the comparison group was a waitlist control group, even when physical activity and other therapeutic approaches were controlled for. In the present study, we aimed to investigate the effectiveness of a manualised psychotherapeutic bouldering intervention for depressed individuals, compared with an active control group performing physical exercise alone. METHODS: In a multicentre randomised controlled intervention trial, 133 outpatients with depression were assigned to either a bouldering psychotherapy (BPT) group or a home-based supervised exercise programme (EP). Severity of depression as the primary outcome was assessed at baseline and directly after a ten-week intervention period using the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary outcomes included anxiety, coping skills, self-esteem, body image, and interpersonal sensitivity. We applied t-tests to test for differences within the groups (t0 vs. t1) and between the BPT and the EP and a multiple regression analysis with the post-intervention MADRS score as the dependent variable. The robustness of estimates was investigated with a sensitivity analyses. RESULTS: Patients in the BPT group showed a significantly larger decrease in depression scores compared with the EP on the MADRS (drop of 8.4 vs. 3.0 points, p = .002, Cohen's d = 0.55). In the confounder-adjusted regression analyses, group allocation was found to be the only significant predictor of the post-intervention MADRS score (ß = - 5.60, p = .001) besides the baseline MADRS score. Further significant differences in change scores between the BPT and the EP were found for anxiety (p = .046, d = 0.35), body image (p = .018, d = 0.42), and global self-esteem (p = .011, d = 0.45). CONCLUSIONS: The study provides evidence that the manualised BPT is not only effective in alleviating depressive symptoms but even goes beyond the effect of mere physical exercise. Based on these findings, the BPT should be considered as a complementary therapeutic approach. TRIAL REGISTRATION: Trial identification number: ISRCTN12457760: Study KuS (Klettern und Stimmung - Climbing and Mood) combined boulder and psychotherapy against depression, registered retrospectively on July 26th, 2017.

[Impact of Sedating Drugs on Falls Resulting Injuries Among People with Dementia in a Nursing Home Setting]. / Einfluss zentralnervös dämpfender Arzneimittel auf Stürze mit Verletzungsfolgen bei Menschen mit Demenz in Pflegeheimen.

AIM: The aims of this study were to create a scale for measuring the sedating and activating effects of drugs and to analyse if the total value of this scale correlates significantly with falls requiring medical treatment in dementia patients. Furthermore, prescription of drugs in nursing homes included in the PRISCUS-List, Anticholinergic Cognitive Burden List (ACB-List) and usage of psychotropic drugs were investigated. METHOD: This is a data analysis of a randomized controlled trial which tested the effects of a non-pharmacological multimodal activation therapy (MAKS®) in 139 patients with degenerative dementia in 5 nursing homes. At the beginning of the study, all prescribed drugs were rated on a five-tier scale by 2 pharmacologists based on the drugs' sedating or activating effects. The scale ranged from severely activating (+2) to severely sedating (- 2). The "central nervous system (CNS) depressant score" of each patient was calculated by summing up the scale value of all the medications they were taking. The correlation between CNS-depressant score and falls resulting in injuries within an observation period of 12 months was investigated by binary logistic regression analysis. RESULTS: Nearly 30% of the nursing home residents received drugs listed in the PRISCUS-list, 50% received drugs on the ACB-List, 55% took psychotropic drugs and 66% received at least 5 drugs. Sedating drugs were prescribed to 62% of patients. During the observation period, 36 out of 139 nursing home residents suffered falls and medical treatment was necessary. In multivariate analysis, the CNS-depressant score was associated significantly (p=0.045) with falls with resulting injuries. Increased sedation resulted in a higher number of fall incidents. CONCLUSIONS: The CNS-depressant score is a useful tool to describe the degree of sedation. Due to the significant association between sedation and falls resulting in injuries, the sedating medication of people suffering from dementia should be minimised as much as possible to reduce the risk of undesirable side effects.

Long-term effects of bouldering psychotherapy on depression: benefits can be maintained across a 12-month follow-up.

BACKGROUND: Previous studies have identified positive effects of Bouldering Psychotherapy (BPT) on symptoms of depression. The aim of the present study was to investigate the short- and long-term effects of BPT on 97 participants with depression. METHODS: BPT took place once a week over a period of 8 weeks. In a waitlist control group design, participants were assessed at baseline and after 8 weeks (end of BPT for the intervention group; start of BPT for the waitlist group), 16 weeks, and 12 months. The main outcome was severity of depression measured with the Beck Depression Inventory II (BDI-II). RESULTS: Depression scores dropped by 7.21 on the BDI-II during the first intervention period with a Cohen's d of 0.59. A regression analysis at t1 showed that group allocation (p < .001) was the only significant predictor besides the baseline depression score (p < .001). A 12-month (after t0) follow-up measurement showed that the decrease in depression severity remained stable during that time, with values of d = 0.37 for the intervention group and d = 0.43 for the waitlist group. LIMITATIONS: Limitations of the study are the assessment of symptoms via only self-report, the lack of a control group during follow-up, and different durations of the follow-up period in the two groups. CONCLUSION: Our results augment the findings of previous studies regarding the short-term effects of BPT and provide initial evidence that the positive effects of BPT on depression severity can be maintained across a period of 12 months.

Responder Analysis of a Multicomponent Non-Pharmacological Intervention (MAKS) for People With Cognitive Impairment in the German Day-Care Study (DeTaMAKS).

Background: Multicomponent non-pharmacological therapies have been shown to be effective at reducing cognitive symptoms and slowing deterioration in abilities to perform activities of daily living (ADL) in individuals with cognitive impairment. However, little is known about response rates and predictors of response. Methods: We used data from the German day-care study (DeTaMAKS; De = dementia, Ta = Tagespflege/day-care, M = motor stimulation, A = activities of daily living stimulation, K = k/cognitive stimulation, S = social stimulation; n = 362), which was based on a cluster-randomized trial of the non-pharmacological, multicomponent, anti-dementia MAKS therapy for people with cognitive impairment in day-care centers. We investigated response (defined as improvement or no deterioration) for three different response criteria: cognition via Mini-Mental State Examination (MMSE) score, ADL via Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment (ETAM) score, and behavioral and psychological symptoms of dementia (BPSD) via Neuropsychiatric Inventory Questionnaire (NPI-Q) score. In addition, we calculated the number needed to treat (NTT) and response rates according to net gain analyses. Results: For all three criteria, the response rates were higher in the intervention group than in the control group (chi2 test: p = 0.058 to p = 0.003). Compared with non-responders, responders according to cognition had higher ETAM scores (= better ADL abilities) at baseline; responders according to ADL had lower ETAM scores (= poorer ADL abilities) at baseline; and responders according to BPSD had higher NPI-Q scores (= more BPSD) at baseline. Classification rates based on these predictors ranged from 60.6 to 68.3%. Discussion: The response rates to the non-pharmacological MAKS therapy were greater than those reported for anti-dementia drugs. There were only a few differences between responders and non-responders. Because of the low classification rates, these variables had only a small impact on response predictions. Therefore, there are no empirically substantiated selection criteria for the application of MAKS therapy in facilities. Clinical Trial Registration: www.ClinicalTrials.gov, identifier ISRCTN16412551.

Can brief telephone interventions reduce caregiver burden and depression in caregivers of people with cognitive impairment? - long-term results of the German day-care study (RCT).

BACKGROUND: Day-care and telephone counseling have been discussed as effective support measures for caregivers of people with cognitive impairment. METHODS: In a two-arm cluster-randomized trial involving multicomponent therapy for cognitively impaired persons in day-care centers and telephone counseling for their caregivers versus treatment as usual (TAU), we investigated long-term effects on caregivers' burden and depressiveness. Person-caregiver dyads involving home-dwelling persons with MCI, mild dementia, or moderate dementia were eligible. Day-care centers were randomized into an intervention group (IG) or a control group (CG). Outcome assessors were blinded. Out of 359 caregivers who had completed a 6-month intervention phase (nIG = 205, nCG = 154), a total of 304 of them were available at the 12-month follow-up (nIG = 173, nCG = 131). Instruments for assessing were the Burden Scale for Family Caregivers - short version (BSFC-s) (caregiver burden) and the Well-Being Index Score (WHO-5) (depressiveness). Mixed ANOVAs were used for the main analyses; descriptive statistics and subgroup analyses were additionally performed; secondary analyses involved multiple linear regressions for the main outcomes that were significant in the unadjusted main analysis. RESULTS: At follow-up, crude mean differences showed a nonsignificant advantage for the IG in caregiver burden [IG: -.20 (SD = 5.39) vs. CG: .76 (SD = 5.49), p = .126, d = .177] and depressiveness (reverse scored) [IG: -.05 (SD = 5.17) vs. CG: -.98 (SD = 5.65), p = .136, d = .173]. For caregiver burden, a mixed ANOVA resulted in significant main effects of group (F (1, 302) = 4.40; p = .037) and time (F (1.88, 568.96) = 3.56; p = .032) but not a significant interaction. The largest effects were found for the "mild dementia" subgroup (d = .443 for caregiver burden and d = .520 for depressiveness). DISCUSSION: Positive long-term effects of a combined intervention involving telephone counseling for caregivers and multicomponent activation for patients were observed especially for mild dementia. However, the treatment effects washed out after the intervention ended. TRIAL REGISTRATION: ISRCTN16412551 (date: 30 July 2014, retrospectively).

A German climbing study on depression: a bouldering psychotherapeutic group intervention in outpatients compared with state-of-the-art cognitive behavioural group therapy and physical activation - study protocol for a multicentre randomised controlled trial.

BACKGROUND: Besides classical approaches for treating depression, physical activity has been demonstrated to be an effective option. Bouldering psychotherapy (BPT) combines psychotherapeutic interventions with action-oriented elements from the field of climbing. The aim of this study is to investigate the effectiveness of BPT compared with a home-based exercise program (EP - active control group, superiority trial) and state-of-the-art cognitive behavioural therapy (CBT - non-inferiority trial). METHODS: The study is being conducted as a multicentre randomised controlled intervention trial at three locations in Germany. Participants are being randomised into three groups: BPT, CBT, or EP, each with a 10-week treatment phase. A power analysis indicated that about 240 people should initially be included. The primary outcome of the study is the Montgomery and Asberg Depression Rating Scale (MADRS) directly after the intervention. Additional measurement points are located three, six, and 12 months after the end of the intervention. The data are being collected via computer-assisted telephone interviews. Statistical analyses comprise regression analyses to test for the superiority of BPT over EP. To test for the non-inferiority of BPT and CBT, a non-inferiority margin of 1.9 points in the Patient Health Questionnaire (PHQ-9) and two non-inferiority margins for the MADRS (half of the two smallest Cohen's d values from the current meta-analyses) was predefined. The mean difference between CBT and EP is being used as a supplementary equivalence margin. DISCUSSION: This is the first study to investigate the effect of a bouldering psychotherapy (BPT) on outpatients' depressive symptoms compared with mere physical activity (superiority analysis) and state-of-the-art cognitive behavioural therapy (CBT, non-inferiority analysis). Methodological strengths of the study are the elaborated, multicentred, randomised, controlled design. Assessors are blinded with regard to group allocation which leads to high objectivity. The study is conducted in a naturalistic setting, which leads to high external validity. Methodological limitations might be the clinical heterogeneity of the sample, which may dilute the intervention effects. TRIAL REGISTRATION: ISRCTN12457760 (Registration date: 26 July 2017, retrospectively registered).

Brief telephone counselling is effective for caregivers who do not experience any major life events - caregiver-related outcomes of the German day-care study.

BACKGROUND: To date, there has been a dearth of scientifically tested, established intervention concepts focussed on supporting informal caregivers and embedded in routine health care structures. The aim of this study was to assess effects of a brief telephone intervention for caregivers of persons with cognitive impairment (PCIs) on caregivers' depressiveness and subjective burden. METHODS: A two-arm cluster-randomised controlled intervention study was carried out at 32 German day-care centres. During the six-month intervention period, informal caregivers in the intervention group (n = 205) received counselling in three phone calls focussed on stress reduction, development of self-management strategies, and how to deal with challenging behaviours. Both the control group (n = 154) and the intervention group were free to take part in any support programmes offered by the German Health Care System (TAU). Caregivers' subjective burden and depressiveness were measured with the Burden Scale for Family Caregivers - short version (BSFC-s) and the WHO-5 Well-Being Index (WHO-5). Outcomes were assessed by means of computer-assisted telephone interviews (CATIs) at baseline and at the end of the six-month intervention phase. Multiple regression analyses were used to show the influence of group allocation. RESULTS: After the intervention phase, group allocation was not found to significantly predict caregivers' subjective burden or depressiveness. The baseline scores (p < 0.001) were the only significant predictors of change in both outcomes. However, sensitivity analyses for caregivers who did not experience any events that they felt were major (in a negative or positive sense) during the six months (n = 271) showed that group allocation (p < 0.05) was a significant predictor of positive change in both outcomes (BSFC-s: Δ-1.3, [- 2.4, - 0.3], Cohen's d = 0.27; WHO-5: Δ1.5, [0.4, 2.7], Cohen's d = 0.26). Effect sizes were highest in the subgroup of caregivers of people with mild dementia (BSFC-s: Cohen's d = 0.43; WHO-5: Cohen's d = 0.42). CONCLUSIONS: A "low-dose" psychoeducative telephone intervention designed to empower caregivers is effective, especially in an early stage, if the overlap between the effect of the intervention and the effect of events that are experienced as major events in the caregiver's life is considered. TRIAL REGISTRATION: Identifier: ISRCTN16412551 (Registration date: 30 July 2014, registered retrospectively).