Connect-ROD - development and qualitative evaluation of a community-based group intervention to support well-being in patients with a rare or orphan disease.

BACKGROUND: Patients living with various rare or orphan diseases (ROD) experience common psychosocial difficulties. Those need emerge from a combination of factors, such as the large variety of patients and the rarity of resources, as well as concentrated efforts on physical health needs that yielded increases in life expectancy and quality in patients. A gap is therefore rising in the consideration of psychosocial needs of patients, such as coping with the impacts of physical limitations, reducing social isolation and distress. To contribute to address this gap, we developed, pilot-tested and evaluated the acceptability, feasibility, implementation, and short-term effects of Connect-ROD, an online group intervention to support adult patients with a ROD (AP-ROD), which aims to improve coping mechanisms, reinforce sense of control, and support personal goals of AP-ROD. A qualitative study comprising of in-depth pretests, post-test interviews and standardized questionnaires, was conducted with 14 participants in two consecutive intervention groups. RESULTS: The Connect-ROD intervention is strongly anchored in acceptance and commitment therapy as well as community psychology approaches. A pilot test allowed us to improve on the initial structure and to produce a manualized 10-week program delivered online, made up of 2-h sessions comprising formal activities, exchanges and homework. The evaluation showed satisfactory acceptability and accessibility, compliant delivery by facilitators, and promising short-term effects on personal objectives, sense of control, coping mechanisms, symptom management, acceptance of the emotions associated with the disease, distress, self-efficacy, social support and connectedness. The program did not show short-term effects on overall quality of life. CONCLUSION: It is recommended that Connect-ROD is evaluated on a larger scale. It seems promising to support various AP-ROD who live with the complex psychosocial consequences of their disease.

Neuropsychology intervention for managing invisible symptoms of MS (NIMIS-MS) group: A pilot effectiveness and acceptability study.

BACKGROUND: People with MS (pwMS) commonly experience a range of hidden symptoms, including cognitive impairment, anxiety and depression, fatigue, pain, and sensory difficulties. These "invisible" symptoms can significantly impact wellbeing, relationships, employment and life goals. We developed a novel bespoke online group neuropsychological intervention combining psychoeducation and cognitive rehabilitation with an Acceptance and Commitment Therapy (ACT)-informed approach for pwMS in an acute tertiary hospital. This 'Neuropsychological Intervention for Managing Invisible Symptoms' in MS (NIMIS-MS) consisted of 6 sessions, each with a psychoeducation and ACT component. The content included psychoeducation around managing cognitive difficulties, fatigue, pain, sleep and other unpleasant sensations in MS with the general approach of understanding, monitoring, and recognising patterns and potential triggers. Specific cognitive rehabilitation and fatigue management strategies were introduced. The ACT-informed component focussed on three core ACT areas of the 'Triflex' of psychological flexibility (Harris, 2019): Being Present, Opening Up, and Doing What Matters. METHODS: 118 pwMS attended the NIMIS-MS group intervention which was delivered 14 times in six-week blocks over an 18-month period. To evaluate the effectiveness and acceptability, participants completed measures of depression and anxiety (HADS), functional impairment (WSAS), Values- Progress (VQ) and Values- Obstruction (VQ), and Acceptance of MS (MSAS) pre and post NIMIs-MS group intervention. Qualitative feedback was obtained during focus groups after the final session and via online feedback questionnaires RESULTS: Pre-post analysis showed that symptoms of depression and anxiety were significantly lower and acceptance of MS was significantly higher following completion of the NIMIS-MS group. Qualitative feedback showed that participants reported that they felt more equipped to manage the "invisible" symptoms of MS following completion of the group, and benefited from using ACT-based strategies and techniques. Participants highly valued the peer support that evolved during the NIMIS-MS groups. The online format was considered more accessible than in-person groups, due to less concerns of travel time, cost, fatigue, and comfort and infection. CONCLUSION: Evaluation suggests that our novel NIMIS-MS groups is an acceptable, beneficial and feasible approach for providing neuropsychological interventions to individuals with MS.

Evaluation of "Cognitive Behavioral Intervention for Trauma in Schools" (CBITS) in child welfare programs in Germany: study protocol of a randomized controlled trial.

BACKGROUND: Children and adolescents growing up in child welfare institutions have been frequently exposed to traumatic events and psychosocial stress and show elevated rates of mental disorders. Yet, there is a lack of empirically supported treatments to provide adequate mental health care for children in care suffering from trauma-related mental disorders such as posttraumatic stress disorder (PTSD), depression, and anxiety. The Cognitive Behavioral Intervention for Trauma in Schools (CBITS) is an evaluated trauma-focused cognitive-behavioral group intervention, which has proven to be effective in reducing symptoms of PTSD, depression, and anxiety for traumatized children in group settings. The trial will evaluate the effectiveness of the CBITS intervention as an outreach treatment compared with an enhanced treatment-as-usual condition (TAU +) within the German mental health and child welfare system. METHODS: In a randomized controlled trial (RCT) involving N = 90 children and adolescents, we will compare CBITS with TAU + . Participants between 8 and 16 years, reporting at least one traumatic event and moderate posttraumatic stress symptoms (PTSS), will be randomized within their child welfare institution to either one of the conditions using a CATS-2 severity-stratified block randomization. Assessments will take place at baseline, as well as 4 months and 10 months after baseline. The primary outcome is the severity of PTSS after 4 months. Secondary outcomes are depression, anxiety, irritability/anger, quality of life, and global functioning level. DISCUSSION: The results of our trial will provide evidence regarding effective treatment options for traumatized children in care, which represent an understudied population with limited access to mental health care. Additionally, it could serve as a blueprint for implementing trauma-focused outreach group treatments for children in care and increase the accessibility to appropriate treatment. TRIAL REGISTRATION: Clinical Trials.gov NCT06038357 D. September 13, 2023.

A pilot study of the Moving On In My Recovery program for people in recovery from substance use.

Background: This study pilot tested Moving On In My Recovery (MOIMR), a 12-session, acceptance-based, cognitive-behavioral, manual-guided group program for individuals in recovery from substance use. MOIMR aims to bridge the gap between formal treatment and sustained recovery. Method: Participants were 61 people in recovery from substance use and in the catchment area of the Betsi Cadwaladr Health Board, North Wales, United Kingdom. Using a variety of questionnaires, participants' psychological flexibility and wellbeing were assessed at baseline, post-treatment, and a three-month follow-up. Participants who dropped out were contacted at the follow-up and interviewed about their experience. Results: The study successfully recruited participants from real-world treatment services. During the study, significant improvements were observed in participants' social functioning, experiential avoidance, recovery capital, low mood, and anxiety. The proportion of participants who achieved abstinence also improved. Qualitative feedback confirmed the benefits that participants derived from attending the MOIMR groups. Conclusion: The program offered significant benefits for the participants despite many of them having apprehensions about undertaking a group-based approach. The gains established by quantitative analysis appeared to be supported by the qualitative findings. These findings suggest that a full randomized controlled trial of MOIMR would be feasible.

Dose-Response Effects of MittEcho, a Measurement Feedback System, in an Indicated Mental Health Intervention for Children in Municipal and School Services in Norway.

Including routine client feedback can increase the effectiveness of mental health interventions for children, especially when implemented as intended. Rate of implementation, or dose, of such feedback interventions has been shown to moderate results in some studies. Variation in implementation and use of client feedback may also contribute to the mixed results observed within the feedback literature. This study evaluates dose-response associations of client feedback using a novel Measurement Feedback System (MFS) within an indicated group intervention. The primary aim was to determine whether the rate of MFS implementation predicts symptom reduction in anxiety and depression among school-aged children. The secondary aim was to assess whether the rate of MFS implementation influences children's satisfaction with the group intervention or their dropout rates. Data were collected via a randomized factorial study (clinicaltrials.gov NCT04263558) across 58 primary schools in Norway. Children aged 8 to 12 years (N = 701) participated in a group-based, transdiagnostic intervention targeting elevated symptoms of anxiety or depression. Half of the child groups also received the feedback intervention using the MittEcho MFS. Group leaders (N = 83), recruited locally, facilitated the interventions. The MFS dose was measured using the Implementation Index, which combines the use of MFS by both children and providers (group leaders) into a single dose variable. Results showed no significant additional effect of dose of MFS on change in depression or anxiety scores, on user satisfaction with the intervention or on intervention dropout. The discussion addresses potential reasons for these non-significant findings and implications for MFS implementation in preventive, group-based interventions in school settings.

Group Intervention Program to Facilitate Post-Traumatic Growth and Reduce Stigma in HIV.

Background: Research on post-traumatic growth (PTG) and HIV is scarce and the relationship between PTG and stigma is controversial. Group psychotherapeutic interventions to facilitate PTG in clinical samples are effective but none exist to simultaneously decrease stigma in the HIV population. The main objective was to evaluate the effectiveness of an intervention in increasing PTG and decreasing stigma in HIV, as well as to explore relationships between the variables. Methods: Quasi-experimental design with a sample of 42 HIV-positive adults (M = 46.26, SD = 11.90). The experimental group (EG) was subjected to a 9-week group intervention. Instruments: CBI, PTGI-X, PSS-10, HIV stigma, emotional expression, HIV stress indicators, HIV literacy, and skills. Multiple linear regression analysis was performed to assess the relationship between the variables. Results: There was an increase in PTG and a significant decrease in stigma in all domains and subscales in the EG. Compared to the control group, stigma (t(42) = -3.040, p = 0.004) and negative self-image (W = -2.937, p = 0.003) were significant, showing the efficacy of the intervention. Discussion: The intervention demonstrated success in facilitating PTG, attesting that in order to increase PTG, personal strength, and spiritual change, it is necessary to reduce stigma and negative self-image. The research provides more information on group interventions for PTG in HIV, relationships between variables, and population-specific knowledge for professionals.

A pilot randomised control study to investigate the effect of the South African Adolescence Group Sleep Intervention (SAASI) on adolescent sleep and PTSD.

Background: Trauma exposure prevalence and consequent post-traumatic stress disorder among South African adolescents are significant. Sleep disturbances are among the most frequently reported difficulties faced by those dealing with PTSD. The current study examined the feasibility and preliminary efficacy of the South African Adolescence Group Sleep Intervention on PTSD symptom severity and sleep disturbance.Method: Sixty-one adolescents with PTSD diagnoses and sleep disturbance were randomly assigned (1:1) to one individual and four group sessions of a sleep intervention (SAASI) or a control group. Participants completed the Child PTSD symptom scale for DSM5 (CPSS-5) and the Pittsburgh Sleep Quality Index (PSQI) among other sleep and psychiatric measures. The trial was registered on the Pan African Trial Registry (PACTR202208559723690).Results: There was a significant but similar decrease in PSQI scores in both groups over time indicating no overall intervention effect (Wald test = -2.18, p = .029), mean slope = -0.2 (95% CI: -0.37 to -0.02) (p = .583). On the CPSS-5, interaction between groups was also not significant (p = .291). Despite this overall finding, the mean difference in CPSS-SR-5 scores increased over time, with the difference between groups post-treatment -9.10 (95%CI: -18.00 to -0.21), p = .045 and the 1-month follow-up contrast - 11.22 (95%CI: -22.43 to -0.03), p = .049 suggesting that PTSD symptom severity decreased more in the intervention group than the control group. The dropout rate was higher than expected for both the intervention (n = 10; 32%) and control (n = 8; 26.7%) groups. Dropout were mostly school commitments or travel related.Conclusions: Early findings suggest a trend towards dual improvement in sleep quality and PTSD symptom severity in adolescents with a sleep disturbance and PTSD receiving a group sleep intervention (SAASI). Further investigation in a properly powered RCT with detailed retention planning is indicated.

A four-week group sleep intervention seems feasible in adolescents with PTSD and sleep disturbances in a low-resource South African setting.Utilising less specialised mental health resources such as nurses and counsellors in intervention delivery was feasible and effective.Preliminary results are promising and support further research to establish the efficacy of the intervention.

Acceptability and feasibility of a short-term group therapy for people with borderline personality disorder symptoms.

OBJECTIVE: This study evaluated the acceptance, feasibility and safety of a short-term group program for adults (18 years and older) and youth (16 to 18 years) with borderline personality disorder (BPD) symptoms. Termed Road Maps, the content and development were informed by common treatment factors identified from evidence-based therapies for BPD. METHOD: Two-hundred and eight people consented to participate in the research trial and completed baseline measures. Intervention participants rated the acceptability and subjective experience of the group. Attrition rates informed feasibility, and serious adverse events were tracked to identify potential harms. RESULTS: Participant post-group ratings of the group's acceptability and subjective experience were above average across both adult and youth populations. Attrition rate after commencement of group was 38% for adults and 27% among youth. The incidence rate of emergency department presentations was reduced by 41% in the 6 months post-group, relative to 6 months pre-group. CONCLUSIONS: The current study provides preliminary support for the acceptability and feasibility of a short-term group therapy program for people with a diagnosis of BPD. Road Maps may be a useful intermediate intervention in a broader model of stepped care. Australian New Zealand Clinical Trials Registry, https://www.anzctr.org.au/ACTRN12622000849796.aspx, (ACTRN12622000849796).

Examining the Impact of Group-Based Social Skills Intervention in Autistic Children Aged Eight to 15 Years.

Introduction Autism spectrum disorder (ASD) is a neurological and developmental disorder, which poses challenges to social communication and behavior, particularly affecting social functioning. Individuals with ASD face significant social challenges, including difficulty understanding social cues and body language, limited ability to engage in reciprocal social interactions, and challenges with establishing empathy. A preference for routines and repetitive behaviors limits their ability to adapt to new or unexpected social situations. These problems tend to escalate during adolescence. These often cause distress to the individual as well as the caregivers. Group-based social skills interventions (GSSIs) are a widely used and effective modality for addressing core social impairments in children with autism. This study aims to assess the impact of GSSI on the broad age group of eight to 15 years, involving parents to enhance the transferability of children's social skills. Methods This was a single-arm interventional study where 30 verbal autistic children, aged eight to 15 years, with intelligence quotient (IQ) > 70 were enrolled after utilizing the Binet Kamat Test of Intelligence (BKT) to assess IQ and the Indian Scale for Assessment of Autism (ISAA) to grade severity of autism. The children received GSSI from interdisciplinary therapists for 12 sessions, on a weekly basis, lasting 90 minutes each for a period of three months. After each therapy session, parents received summaries of each session and were delegated reinforcing homework assignments to enable generalization and maintenance of the skills taught. Outcome measures were taken at three points in time by utilizing the Social Communication Questionnaire (SCQ) and the parent-rated Social Responsiveness Scale 2 (p-SRS-2): T1: pre-therapy at the time of enrolment; T2: immediately post-therapy at the end of three months of training; and T3: long-term follow-up, three months after the end of training. Results Mean SCQ scores were as follows: T1 = 21.87, T2 = 18.57, and T3 = 18.57 (p = 0.000). This progressive decline at T1, T2, and T3 indicated a decreasing trend in the severity of difficulties in the social communication domain. Mean p-SRS-2 scores were as follows: T1 = 73.00, T2 = 64.57, and T3 = 64.30 (p < 0.0001). This declining trend at T1, T2, and T3 suggested a statistically significant decrease in the severity of difficulties faced in various social aspects tested by the p-SRS-2, i.e., social awareness, social cognition, social communication, and social motivation, along with a reduction in restricted interests and repetitive behaviors (RRBs). Very strong correlation coefficients were obtained for SCQ scores (T1-T2 = 0.921, T1-T3 = 0.921, and T2-T3 = 1.000), as well as for p-SRS-2 scores (T1-T2 = 0.743, T1-T3 = 0.746, and T2-T3 = 0.989), which reinforced the statistical significance of the data. Conclusion GSSI is an effective parent-assisted intervention for adolescents with ASD, with effects lasting up to three months post-intervention.

Practicing self-hypnosis to reduce chronic pain: A qualitative exploratory study of HYlaDO.

Background: Nearly a quarter of Canada's population suffers from chronic pain, a long-lasting medical condition marked by physical pain and psychological suffering. Opioids are the primary treatment for pain management in this condition; yet, this approach involves several undesirable side effects. In contrast to this established approach, non-pharmacological interventions, such as medical hypnosis, represent an efficient alternative for pain management in the context of chronic pain. HYlaDO is a self-hypnosis program designed to improve pain management for people with chronic pain. Purpose: This research aimed to evaluate the HYlaDO program based on the proof-of-concept level of the ORBIT model and investigated participants' subjective experience. Research design: Qualitative study. Study sample: Seventeen participants with chronic pain took part in this study. Data collection: We conducted individual semi-structured interviews with patients who had participated in HYlaDO to identify the three targets of desired change: pain, anxiety and autonomy in self-hypnosis practice. Results: Thematic analysis revealed that the practice of hetero-hypnosis and self-hypnosis decreased (i) pain and (ii) anxiety. Also, it (iii) indicated the development of an independent and beneficial self-hypnosis practice by having integrated the techniques taught. Conclusion: These results confirm that the established targets were reached and support further development, implementation and scaling up of this program. Consequently, we believe it is justified to move to the next step of program development.

Group-Related Variables in Intervention Programs for Intimate Partner Violence Perpetrators: A Systematic Review.

Intervention programs for male intimate partner violence (IPV) perpetrators mostly use the group intervention modality. Notwithstanding, the literature has neglected the study of group-related variables and their possible association with these interventions' functioning and outcomes. This systematic review aimed to analyze group-related variables, their predictors, and their relation to the functioning and outcomes of intervention programs for IPV perpetrators. The systematic review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The following databases were searched from inception to November 2022: Web of Science, Scopus, PUBMED, and PsycINFO. Of the 5,941 identified studies, 13 were included in the review. The main predictors of group-related variables were: intervention stage, motivational strategies, and leadership (counseling approach). The group-related variables as predictors of intervention outcomes were: group management behaviors and support (facilitator behavior within the group); positive confrontation, protherapeutic behavior, active involvement, positive interaction with peers, and positive interaction with the facilitator (participant behavior within the group); and group cohesion and group climate (group dynamics). Group cohesion and participants' protherapeutic behavior stood out for their association with positive treatment outcomes (i.e., greater participation and working alliance, lower rates of violent behavior during follow-up). The findings from this review suggest that group processes are key factors in intervention programs for IPV perpetrators, and a better understanding of how these group processes are shaped, and how they can contribute to positive program outcomes, provides a new approach and insights to improve their effectiveness.

Digital adaptation of the Standing up for Myself intervention in young people and adults with intellectual disabilities: the STORM feasibility study.

Background: Stigma contributes to the negative social conditions persons with intellectual disabilities are exposed to, and it needs tackling at multiple levels. Standing Up for Myself is a psychosocial group intervention designed to enable individuals with intellectual disabilities to discuss stigmatising encounters in a safe and supportive setting and to increase their self-efficacy in managing and resisting stigma. Objectives: To adapt Standing Up for Myself to make it suitable as a digital intervention; to evaluate the feasibility and acceptability of Digital Standing Up for Myself and online administration of outcome measures in a pilot; to describe usual practice in the context of the coronavirus disease 2019 pandemic to inform future evaluation. Design: Adaptation work followed by a single-arm pilot of intervention delivery. Setting and participants: Four third and education sector organisations. Individuals with mild-to-moderate intellectual disabilities, aged 16+, members of existing groups, with access to digital platforms. Intervention: Digital Standing Up for Myself intervention. Adapted from face-to-face Standing Up for Myself intervention, delivered over four weekly sessions, plus a 1-month follow-up session. Outcomes: Acceptability and feasibility of delivering Digital Standing Up for Myself and of collecting outcome and health economic measures at baseline and 3 months post baseline. Outcomes are mental well-being, self-esteem, self-efficacy in rejecting prejudice, reactions to discrimination and sense of social power. Results: Adaptation to the intervention required changes to session duration, group size and number of videos; otherwise, the content remained largely the same. Guidance was aligned with digital delivery methods and a new group member booklet was produced. Twenty-two participants provided baseline data. The intervention was started by 21 participants (four groups), all of whom were retained at 3 months. Group facilitators reported delivering the intervention as feasible and suggested some refinements. Fidelity of the intervention was good, with over 90% of key components observed as implemented by facilitators. Both facilitators and group members reported the intervention to be acceptable. Group members reported subjective benefits, including increased confidence, pride and knowing how to deal with difficult situations. Digital collection of all outcome measures was feasible and acceptable, with data completeness ≥ 95% for all measures at both time points. Finally, a picture of usual practice has been developed as an intervention comparator for a future trial. Limitations: The pilot sample was small. It remains unclear whether participants would be willing to be randomised to a treatment as usual arm or whether they could be retained for 12 months follow-up. Conclusions: The target number of groups and participants were recruited, and retention was good. It is feasible and acceptable for group facilitators with some training and supervision to deliver Digital Standing Up for Myself. Further optimisation of the intervention is warranted. Future work: To maximise the acceptability and reach of the intervention, a future trial could offer the adapted Digital Standing Up for Myself, potentially alongside the original face-to-face version of the intervention. Study registration: This study was registered as ISRCTN16056848. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 17/149/03) and is published in full in Public Health Research; Vol. 12, No. 1. See the NIHR Funding and Awards website for further award information.

People with intellectual disabilities (or 'learning disabilities' in United Kingdom language) are more likely to experience poor physical and mental health than the general population. Stigma (negative stereotypes, prejudice and discrimination) has been linked to lower self-esteem, quality of life, and mental and physical ill health. Efforts to empower people with intellectual disabilities themselves to challenge stigma with a view to improving well-being, health and self-esteem are lacking. In 2017, we developed Standing Up for Myself, a brief group-based programme for people with mild-to-moderate intellectual disabilities aged 16+ to address this gap. As this study got underway, face-to-face meetings were suspended due to the coronavirus disease 2019 pandemic. We used the opportunity to assess whether Standing Up for Myself could be delivered through web-based meetings. We adapted Standing Up for Myself for digital delivery, with close input from advisors with intellectual disabilities and experienced group facilitators. We then tested the digital version in charity and education settings to evaluate if Digital Standing Up for Myself could be delivered as planned and how acceptable it was to group facilitators and participants. Four groups, with a total of 22 members, signed up to try Digital Standing Up for Myself. One participant dropped out before starting Standing Up for Myself, and the other 21 continued until the end of the programme. Retention and attendance were good; participants on average attended four of the five sessions. Ninety per cent of the core programme requirements were fully delivered as detailed in the Digital Standing Up for Myself manual. Problems with technology were manageable, although facilitators found using the Standing Up for Myself Wiki platform (an online platform for storage and sharing of resources) difficult, particularly when sharing video content. Facilitators felt acceptable levels of privacy were achieved and there were no reports of undue distress. All facilitators and many group members said they would recommend Digital Standing Up for Myself to others. Group members shared how the programme benefitted them, noting increased awareness about disabilities, and for some increased confidence, pride and independence. Some had learnt how to stand up for themselves and manage difficult situations and took pride in this. Completing outcome and health cost measures via web-based meetings was acceptable and data were largely fully complete and useable.

Effects of Group Exercise Intervention on Quality of Life and Physical Parameters in Patients with Childhood Cancer: A Systematic Review.

BACKGROUND: Although the survival rates of childhood cancer are increasing, children diagnosed as having cancer experience psychological and physical problems and a declining quality of life (QOL). METHODS: A systematic review of PubMed databases was conducted up to September 2023 to identify studies reporting the effects of group exercise intervention in children with cancer. The inclusion criteria were pre-specified, including children aged ≤19 years old who received group exercise intervention and interventional studies written in English. Studies involving non-exercise intervention or non-group intervention were excluded. RESULTS: Five studies were included in the present review. In three studies, QOL and physical parameters were improved after group exercise intervention, and in two studies, only physical parameters were improved. Improvements in QOL were achieved through psychosocial variables, improved scores of subscales of pain and hurt, nausea, and procedure-related anxiety, and reduced cancer-related fatigue. All studies had high numbers of participants who completed the intervention. However, all studies showed a high risk of bias regarding the selection of the reported results, and most studies showed a high risk of bias regarding deviations from the intended intervention and outcome measurement. CONCLUSION: The reviewed studies showed that group exercise intervention for children with cancer could improve their QOL and/or physical parameters.

Acceptability of a Self-Led Mindfulness-Based Intervention for Teens with Type 1 Diabetes: Pilot Randomized Controlled Trial.

BACKGROUND: Diabetes distress among adolescents with type 1 diabetes has been associated with suboptimal diabetes outcomes, including lower quality of life, increased diabetes self-management challenges, and suboptimal glycemic outcomes. OBJECTIVE: This study examined the feasibility and acceptability of a scalable self-led mindfulness-based intervention to reduce diabetes distress in adolescents with type 1 diabetes. METHODS: Adolescents (N=25) aged between 14 and 18 years diagnosed with type 1 diabetes completed a baseline assessment. Participants were randomized to receive a 10-week self-guided mindfulness-based stress reduction workbook program (e-book or paper option) immediately (n=15) or after a 10-week wait (n=10). During the intervention period, participants completed weekly assignments and feedback surveys. At 10 weeks and 20 weeks, follow-up assessments were completed. RESULTS: Findings indicated that participants did not find the original intervention feasible or acceptable. Adolescents reported barriers to completing the weekly material, such as that they forgot or that the material was not sufficiently related to their diabetes management. Adolescents also reported that a digital format rather than a workbook or e-book may be more acceptable. Results from weekly surveys provided the foundation for recommendations for future iterations of the mindfulness-based intervention for adolescents with type 1 diabetes. CONCLUSIONS: Participant feedback informed recommendations for self-led mindfulness programs for youth with type 1 diabetes. Adolescents indicated that a shorter, digital mindfulness-based intervention focused on diabetes-specific behaviors may be more helpful. TRIAL REGISTRATION: ClinicalTrials.gov NCT05115175; https://clinicaltrials.gov/study/NCT05115175.

Nature-based social interventions to address loneliness among vulnerable populations: a common study protocol for three related randomized controlled trials in Barcelona, Helsinki, and Prague within the RECETAS European project.

BACKGROUND: The negative effects of loneliness on population health and wellbeing requires interventions that transcend the medical system and leverage social, cultural, and public health system resources. Group-based social interventions are a potential method to alleviate loneliness. Moreover, nature, as part of our social and health infrastructure, may be an important part of the solutions that are needed to address loneliness. The RECETAS European project H2020 (Re-imagining Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) is an international research project aiming to develop and test the effectiveness of nature-based social interventions to reduce loneliness and increase health-related quality of life. METHODS: This article describes the three related randomized controlled trials (RCTs) that will be implemented: the RECETAS-BCN Trial in Barcelona (Spain) is targeting people 18+ from low socio-economic urban areas; the RECETAS-PRG Trial in Prague (Czech Republic) is addressing community-dwelling older adults over 60 years of age, and the RECETAS-HLSNK trial is reaching older people in assisted living facilities. Each trial will recruit 316 adults suffering from loneliness at least sometimes and randomize them to nature-based social interventions called "Friends in Nature" or to the control group. "Friends in Nature" uses modifications of the "Circle of Friends" methodology based on group processes of peer support and empowerment but including activities in nature. Participants will be assessed at baseline, at post-intervention (3 months), and at 6- and 12-month follow-up after baseline. Primary outcomes are the health-related quality-of-life according to 15D measure and The De Jong Gierveld 11-item loneliness scale. Secondary outcomes are health and psychosocial variables tailored to the specific target population. Nature exposure will be collected throughout the intervention period. Process evaluation will explore context, implementation, and mechanism of impact. Additionally, health economic evaluations will be performed. DISCUSSION: The three RECETAS trials will explore the effectiveness of nature-based social interventions among lonely people from various ages, social, economic, and cultural backgrounds. RECETAS meets the growing need of solid evidence for programs addressing loneliness by harnessing the beneficial impact of nature on enhancing wellbeing and social connections. TRIAL REGISTRATION: Barcelona (Spain) trial: ClinicalTrials.gov, ID: NCT05488496. Registered 29 July 2022. Prague (Czech Republic) trial: ClinicalTrials.gov, ID: NCT05522140. Registered August 25, 2022. Helsinki (Finland) trial: ClinicalTrials.gov, ID: NCT05507684. Registered August 12, 2022.

Exploring mechanisms of change in the metacognitive training for depression.

The Metacognitive Training for Depression (D-MCT) is a highly structured group therapy that has been shown to be effective in reducing depressive symptoms. First evidence suggests that need for control represents a mechanism of change. However, more research is needed to evaluate the mode of action of each module and identify predictors of treatment response. Two sequential studies (one naturalistic pilot study [study I, N = 45] and one randomized controlled trial [study II, N = 32]) were conducted to evaluate the session-specific effects and predictors of D-MCT in patients with depression. The D-MCT was conducted over eight weeks, and patients answered a questionnaire on dysfunctional beliefs (e.g., negative filter) and depressive symptoms (e.g., lack of energy, self-esteem) before and after each session. Linear mixed-effects models showed that several dysfunctional beliefs and symptoms improved over the course of the treatment; three modules were able to evoke within-session effects, but no between-session effects were found. The improvement in lack of energy in one module was identified as a relevant predictor in study I via lasso regression but was not replicated in study II. Exploratory analyses revealed further predictors that warrant replication in future studies. The identified predictors were inconclusive when the two studies were compared, which may be explained by the different instruments administered. Even so, the results may be used to revise questionnaires and improve the intervention.

Mapping evidence-based interventions to the care of unaccompanied minor refugees using a group formulation approach.

BACKGROUND: How we adapt treatment algorithms to complex, clinically untested, difficult-to-engage patient groups without losing evidence base in everyday practice is a clinical challenge. Here we describe process and reasoning for fast, pragmatic, context-relevant and service-based adaptations of a group intervention for unaccompanied minor asylum seekers (UASC) arriving in Europe. We employed a distillation-matching model and deployment-focused process in a mixed-method, top-down (theory-driven) and bottom-up (participant-informed) approach. Prevalence of mental disorders amongst UASC is extremely high. They also represent a marginalised and hard-to-engage group with limited evidence for effective treatments. METHOD: Content and process adaptations followed four steps: (1) descriptive local group characterisation and theoretical formulation of problems; (2) initial adaptation of evidenced treatment, based on problem-to-component grid; (3) iterative adaptation using triangulated feedback; and (4) small-scale pilot evaluation. RESULTS: Based on evidence and participant feedback, adaptations included minimising verbal demands, facilitating in-session inductive learning, fostering social connectedness via games, enhancing problem-solving skills, accounting for multi-traumatisation, uncertainty and deportation. Quantitative evaluation suggested improved feasibility, with increased attendance, low drop-out and symptom improvement on depression and trauma scores. CONCLUSIONS: By describing the principles under-pinning development of a group intervention for severely traumatised UASC, we contribute to the literature supporting dynamic adaptations of psychological interventions, without losing reference to evidence base. Complex and difficult-to-reach clinical groups are often those in most need of care, yet least researched and most affected by inequality of care. Pragmatic adaptations of proven programs are often necessary to increase feasibility.

Connecting, learning, supporting: Caregivers' experiences of a stress and distress biopsychosocial group intervention.

BACKGROUND: Family caregivers are fundamental in supporting people living with dementia to remain at home, however, psychological distress can occur as a result of their caring role. Research into interventions for caregivers of people living with young-onset dementia, including their experience of and the mediating processes of such interventions, remains limited. METHODS: An Interpretative Phenomenological Analysis explored caregiver experiences and influence on caregiving of participating in a "Responding to Distress in Dementia" group. Five family caregivers were interviewed with discussions covering the period from first noticing symptoms to the interview session. RESULTS: Within the group experience, four superordinate themes were identified: 'connecting to other caregivers', 'learning about caregiving', 'group factors' and 'reduced caregiver distress'. During the post-group period, three superordinate themes were recognised: 'maintaining support', 'applying learning', and 'normalising caregiving'. CONCLUSIONS: The study highlighted several interrelated themes involving creating connections amongst caregivers with similar experiences, social learning, and supportive learning through group structure and facilitation. Many of the processes reflected those found in existing dementia caregiver intervention research. Recommendations included facilitating peer support groups and exploring whole-family approaches.

Feasibility, acceptability and clinical benefit of a trauma-focused stabilisation group for post-traumatic stress disorder patients with complex presentations on primary care waitlists.

BACKGROUND: Large numbers of people showing complex presentations of post-traumatic stress disorder (PTSD) in the NHS Talking Therapies services routinely require multi-faceted and extended one-to-one National Institute of Clinical Excellence (NICE) recommended treatment approaches. This can lead to longer waits for therapy and prolong patient suffering. We therefore evaluated whether a group stabilisation intervention delivered to patients on the waitlist for individual trauma-focused psychological treatment could help address this burden. AIMS: The study aimed to ascertain a trauma-focused stabilisation group's acceptability, feasibility, and preliminary clinical benefit. METHOD AND RESULTS: Fifty-eight patients with PTSD waiting for trauma-focused individual treatment were included in the study. Two therapists delivered six 5-session groups. The stabilisation group was found to be feasible and acceptable. Overall, PTSD symptom reduction was medium to large, with a Cohen's d of .77 for intent-to-treat and 1.05 for per protocol analyses. Additionally, for depression and anxiety, there was minimal symptom deterioration. CONCLUSIONS: The study provided preliminary evidence for the acceptability, feasibility and clinical benefit of attending a psychoeducational group therapy whilst waiting for one-to-one trauma therapy.