Effects of a Chatbot-Based Intervention on Stress and Health-Related Parameters in a Stressed Sample: Randomized Controlled Trial.

BACKGROUND: Stress levels and the prevalence of mental disorders in the general population have been rising in recent years. Chatbot-based interventions represent novel and promising digital approaches to improve health-related parameters. However, there is a lack of research on chatbot-based interventions in the area of mental health. OBJECTIVE: The aim of this study was to investigate the effects of a 3-week chatbot-based intervention guided by the chatbot ELME, specifically with respect to the ability to reduce stress and improve various health-related parameters in a stressed sample. METHODS: In this multicenter two-armed randomized controlled trial, 118 individuals with medium to high stress levels were randomized to the intervention group (n=59) or the treatment-as-usual control group (n=59). The ELME chatbot guided participants of the intervention group through 3 weeks of training based on the topics stress, mindfulness, and interoception, with practical and psychoeducative elements delivered in two daily interactive intervention sessions via a smartphone (approximately 10-20 minutes each). The primary outcome (perceived stress) and secondary outcomes (mindfulness; interoception or interoceptive sensibility; subjective well-being; and emotion regulation, including the subfacets reappraisal and suppression) were assessed preintervention (T1), post intervention (T2; after 3 weeks), and at follow-up (T3; after 6 weeks). During both conditions, participants also underwent ecological momentary assessments of stress and interoceptive sensibility. RESULTS: There were no significant changes in perceived stress (ß03=-.018, SE=.329; P=.96) and momentary stress. Mindfulness and the subfacet reappraisal significantly increased in the intervention group over time, whereas there was no change in the subfacet suppression. Well-being and momentary interoceptive sensibility increased in both groups over time. CONCLUSIONS: To gain insight into how the intervention can be improved to achieve its full potential for stress reduction, besides a longer intervention duration, specific sample subgroups should be considered. The chatbot-based intervention seems to have the potential to improve mindfulness and emotion regulation in a stressed sample. Future chatbot-based studies and interventions in health care should be designed based on the latest findings on the efficacy of rule-based and artificial intelligence-based chatbots. TRIAL REGISTRATION: German Clinical Trials Register DRKS00027560; https://drks.de/search/en/trial/DRKS00027560. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-doi.org/10.3389/fdgth.2023.1046202.

ACTonDiabetes: study protocol of a pragmatic randomised controlled trial for the evaluation of an acceptance and commitment-based internet-based and mobile-based intervention for adults living with type 1 or type 2 diabetes.

INTRODUCTION: Living with diabetes can be burdensome and lead to serious emotional distress and impaired mental health. Acceptance and commitment therapy (ACT) can support people facing the challenges of living with diabetes. This trial aims to evaluate the effectiveness and cost-effectiveness of the internet-based and mobile-based intervention (IMI) 'ACTonDiabetes' in reducing diabetes distress against enhanced treatment as usual (TAU+) following specialised diabetes care. METHODS AND ANALYSIS: A two-armed pragmatic randomised controlled trial will be conducted to evaluate the guided IMI ACTonDiabetes against TAU+. A total of 210 adults with type 1 or type 2 diabetes and elevated diabetes distress (Problem Areas in Diabetes ≥40) will be recruited at a specialised diabetes centre. The intervention begins 2-4 weeks after hospital discharge and takes about 7-10 weeks to complete. Assessments are performed at baseline and 5 and 10 weeks as well as 6 and 12 months after randomisation. The primary outcome is diabetes distress at a 10-week follow-up (T2). Secondary outcomes are depression (Patient Health Questionnaire-8), psychological well-being (WHO-5), quality of life (Assessment of Quality of Life-8 Dimension), Diabetes-related Self-Management Questionnaire, diabetes acceptance (Acceptance and Action Diabetes Questionnaire) and negative treatment effects (Inventory for the Assessment of Negative Effects of Psychotherapy). All statistical analyses will be performed based on the intention-to-treat principle with additional per-protocol analyses. Changes in outcomes will be evaluated using the general linear model. A health-economic evaluation will be conducted from a societal perspective. Reasons for drop-out will be systematically investigated. ETHICS AND DISSEMINATION: This clinical trial has been approved by the State Medical Chamber of Baden-Württemberg (file no. B-F-2019-010). Trial results will be submitted for publication in a peer-reviewed journal and presented at conferences. TRIAL REGISTRATION NUMBER: DRKS00016738.

Psychological and pharmacological interventions for depression in patients with coronary artery disease.

BACKGROUND: Depression occurs frequently in individuals with coronary artery disease (CAD) and is associated with a poor prognosis. OBJECTIVES: To determine the effects of psychological and pharmacological interventions for depression in CAD patients with comorbid depression. SEARCH METHODS: We searched the CENTRAL, MEDLINE, Embase, PsycINFO, and CINAHL databases up to August 2020. We also searched three clinical trials registers in September 2021. We examined reference lists of included randomised controlled trials (RCTs) and contacted primary authors. We applied no language restrictions. SELECTION CRITERIA: We included RCTs investigating psychological and pharmacological interventions for depression in adults with CAD and comorbid depression. Our primary outcomes included depression, mortality, and cardiac events. Secondary outcomes were healthcare costs and utilisation, health-related quality of life, cardiovascular vital signs, biomarkers of platelet activation, electrocardiogram wave parameters, non-cardiac adverse events, and pharmacological side effects. DATA COLLECTION AND ANALYSIS: Two review authors independently examined the identified papers for inclusion and extracted data from the included studies. We performed random-effects model meta-analyses to compute overall estimates of treatment outcomes. MAIN RESULTS: Thirty-seven trials fulfilled our inclusion criteria. Psychological interventions may result in a reduction in end-of-treatment depression symptoms compared to controls (standardised mean difference (SMD) -0.55, 95% confidence interval (CI) -0.92 to -0.19, I2 = 88%; low certainty evidence; 10 trials; n = 1226). No effect was evident on medium-term depression symptoms one to six months after the end of treatment (SMD -0.20, 95% CI -0.42 to 0.01, I2 = 69%; 7 trials; n = 2654). The evidence for long-term depression symptoms and depression response was sparse for this comparison. There is low certainty evidence that psychological interventions may result in little to no difference in end-of-treatment depression remission (odds ratio (OR) 2.02, 95% CI 0.78 to 5.19, I2 = 87%; low certainty evidence; 3 trials; n = 862). Based on one to two trials per outcome, no beneficial effects on mortality and cardiac events of psychological interventions versus control were consistently found. The evidence was very uncertain for end-of-treatment effects on all-cause mortality, and data were not reported for end-of-treatment cardiovascular mortality and occurrence of myocardial infarction for this comparison. In the trials examining a head-to-head comparison of varying psychological interventions or clinical management, the evidence regarding the effect on end-of-treatment depression symptoms is very uncertain for: cognitive behavioural therapy compared to supportive stress management; behaviour therapy compared to person-centred therapy; cognitive behavioural therapy and well-being therapy compared to clinical management. There is low certainty evidence from one trial that cognitive behavioural therapy may result in little to no difference in end-of-treatment depression remission compared to supportive stress management (OR 1.81, 95% CI 0.73 to 4.50; low certainty evidence; n = 83). Based on one to two trials per outcome, no beneficial effects on depression remission, depression response, mortality rates, and cardiac events were consistently found in head-to-head comparisons between psychological interventions or clinical management. The review suggests that pharmacological intervention may have a large effect on end-of-treatment depression symptoms (SMD -0.83, 95% CI -1.33 to -0.32, I2 = 90%; low certainty evidence; 8 trials; n = 750). Pharmacological interventions probably result in a moderate to large increase in depression remission (OR 2.06, 95% CI 1.47 to 2.89, I2 = 0%; moderate certainty evidence; 4 trials; n = 646). We found an effect favouring pharmacological intervention versus placebo on depression response at the end of treatment, though strength of evidence was not rated (OR 2.73, 95% CI 1.65 to 4.54, I2 = 62%; 5 trials; n = 891). Based on one to four trials per outcome, no beneficial effects regarding mortality and cardiac events were consistently found for pharmacological versus placebo trials, and the evidence was very uncertain for end-of-treatment effects on all-cause mortality and myocardial infarction. In the trials examining a head-to-head comparison of varying pharmacological agents, the evidence was very uncertain for end-of-treatment effects on depression symptoms. The evidence regarding the effects of different pharmacological agents on depression symptoms at end of treatment is very uncertain for: simvastatin versus atorvastatin; paroxetine versus fluoxetine; and escitalopram versus Bu Xin Qi. No trials were eligible for the comparison of a psychological intervention with a pharmacological intervention. AUTHORS' CONCLUSIONS: In individuals with CAD and depression, there is low certainty evidence that psychological intervention may result in a reduction in depression symptoms at the end of treatment. There was also low certainty evidence that pharmacological interventions may result in a large reduction of depression symptoms at the end of treatment. Moderate certainty evidence suggests that pharmacological intervention probably results in a moderate to large increase in depression remission at the end of treatment. Evidence on maintenance effects and the durability of these short-term findings is still missing. The evidence for our primary and secondary outcomes, apart from depression symptoms at end of treatment, is still sparse due to the low number of trials per outcome and the heterogeneity of examined populations and interventions. As psychological and pharmacological interventions can seemingly have a large to only a small or no effect on depression, there is a need for research focusing on extracting those approaches able to substantially improve depression in individuals with CAD and depression.

Blended Care in In-Patient Acute Psychiatric Care. The Example of a Group Training for Social Competences in Adults-A Pretest-Posttest Feasibility Study.

INTRODUCTION: Deficits in social skills can be an important modulating factor in the development and progress of various mental disorders. However, limited resources in inpatient care often impede effective social skills training. This study investigates the feasibility of a blended group training for social skills (SST) in an inpatient psychiatric setting. Methods and Analysis: For this one-group pretest-posttest trial, inpatients with a diagnosed mental disorder were recruited. Participation in the blended SST lasted four weeks and took place within usual inpatient psychiatric care. The blended intervention comprised four face-to-face group sessions and three complementary online modules within four weeks. Assessments took place before (t1) and after (t2) the training. Feasibility outcomes (use, acceptance, satisfaction, implementability into usual psychiatric inpatient care) and effectiveness outcomes regarding social skills were assessed. RESULTS: N = 15 participants were recruited. Most patients completed all questionnaires (93%) and all modules of the blended SST concept (60%). All participants (100%) would recommend the blended intervention to a friend. Regarding social skills, exploratory analyses revealed a non-significant medium-sized effect (Cohen's d = 0.5 95%CI 0.3 to 1.25, p = 0.08). DISCUSSION: This trial shows that a blended care SST is feasible for the use in acute psychiatric inpatient care setting. Although the wards were acute, with high turnover and change of inpatients, 60% of participants were treated per protocol over four weeks. Overall, the evidence on blended care concepts in psychiatric care settings is extremely poor to date. Hence, this trial should encourage intensified blended inpatient psychiatric care research.

ACTonDiabetes-a guided psychological internet intervention based on Acceptance and Commitment Therapy (ACT) for adults living with type 1 or 2 diabetes: results of a randomised controlled feasibility trial.

OBJECTIVES: This two-group randomised controlled trial evaluates the feasibility of an Acceptance and Commitment Therapy (ACT)-based internet intervention for diabetes distress in people with diabetes type 1 or type 2. Participants were assigned to a guided self-help intervention (EG) or waitlist control group (CG). SETTING: Recruitment took place following an open recruitment strategy including different diabetes centres, self-help groups and social media platforms. PARTICIPANTS: Eligibility criteria comprised being 18 years of age or older, self-reported diagnosis of type 1 or type 2 diabetes, internet access, sufficient German language skills and written informed consent. INTERVENTION: ACTonDiabetes is an internet-based and mobile-based intervention and comprises an introduction and seven modules (one module per week, processing time about 45-60 min). Intervention contents are based on ACT. PRIMARY AND SECONDARY OUTCOME MEASURES: Participants were assessed before and 8 weeks after randomisation. Primary outcome was feasibility (trial recruitment, acceptability). Potential group differences in diabetes distress and other outcomes at follow-up were analysed using linear regression models with baseline values as predictors. All analyses were based on an intention-to-treat principle, potential negative effects were analysed on per-protocol basis. RESULTS: From October 2017 to April 2018, N=42 people with diabetes consented and were randomised (EG n=21, CG n=21). Forty-three per cent of the EG completed all treatment modules within 8 weeks. Across modules, formative user feedback revealed that contents could be optimised regarding comprehensibility (34%), individualisation (20%) and text amount (21%). Overall, 57% of participants dropped out prior to full treatment completion. There were reductions of diabetes distress in the EG (d=0.65, p=0.042). CONCLUSIONS: Modifications of the intervention content according to the user feedback will be performed to further improve acceptability. Mechanisms to foster intervention adherence should be considered for lowering the attrition rate. ACTonDiabetes is feasible for the implementation in a confirmatory trial. TRIAL REGISTRATION NUMBER: WHO International Clinical Trials Registry Platform via the German Clinical Trials Register (DRKS) (DRKS00013193).

Feasibility of a Software agent providing a brief Intervention for Self-help to Uplift psychological wellbeing ("SISU"). A single-group pretest-posttest trial investigating the potential of SISU to act as therapeutic agent.

BACKGROUND: Software agents are computer-programs that conduct conversations with a human. The present study evaluates the feasibility of the software agent "SISU" aiming to uplift psychological wellbeing. Methods: Within a one-group pretest-posttest trial, N = 30 German-speaking participants were recruited. Assessments took place before (t1), during (t2) and after (t3) the intervention. The ability of SISU to guide participants through the intervention, acceptability, and negative effects were investigated. Data analyses are based on intention-to-treat principles. Linear mixed models will be used to investigate short-term changes over time in mood, depression, anxiety. INTERVENTION: The intervention consists of two sessions. Each session comprises writing tasks on autobiographical negative life events and an Acceptance- and Commitment Therapy-based exercise respectively. Participants interact with the software agent on two consecutive days for about 30 min each. RESULTS: All participants completed all sessions within two days. User experience was positive, with all subscales of the user experience questionnaire (UEQ) M > 0.8. Participants experienced their writings as highly self-relevant and personal. However, 57% of the participants reported at least one negative effect attributed to the intervention. Results on linear mixed models indicate an increase in anxiety over time (ß = 1.33, p = .001). Qualitative User Feedback revealed that the best thing about SISU was its innovativeness (13%) and anonymity (13%). As worst thing about SISU participants indicated that the conversational style of SISU often felt unnatural (73%). CONCLUSION: SISU successfully guided participants through the two-day intervention. Moreover, SISU has the potential to enter the inner world of participants. However, intervention contents have the potential to evoke negative effects in individuals. Expectable short-term symptom deterioration due to writing about negative autobiographical life events could not be prevented by acceptance and commitment therapy-based exercises. Hence, results suggest a revision of intervention contents as well as of the conversational style of SISU. The good adherence rate indicates the useful and acceptable format of SISU as a mental health chatbot. Overall, little is known about the effectiveness of software agents in the context of psychological wellbeing. Results of the present trial underline that the innovative technology bears the potential of SISU to act as therapeutic agent but should not be used with its current intervention content. TRIAL-REGISTRATION: The Trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Studies Register (DRKS): DRKS00014933 (date of registration: 20.06.2018). Link: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014933.

Lessons learned from an attempted randomized-controlled feasibility trial on "WIDeCAD" - An internet-based depression treatment for people living with coronary artery disease (CAD).

Despite the high prevalence of comorbid depression in people living with coronary artery disease (CAD), uptake of psychological treatment is generally low. This study was designed to investigate the feasibility of an internet-based cognitive-behavioral (iCBT) depression intervention for people with CAD and depressive symptoms. METHODS: People with CAD and depressive symptoms (PHQ-9 ≥ 5) were randomly assigned to the eight modules comprising iCBT (N = 18), or waitlist-control (N = 16). Measures were taken at baseline (t1) and at post-treatment (eight weeks after randomization, t2). Feasibility-related outcomes were recruitment strategy, study attrition, intervention dropout, satisfaction, negative effects as well as the potential of the intervention to affect likely outcomes in a future full-scale trial (depression, anxiety, quality of life, fear of progression). Data analyses were based on intention-to-treat principles. Linear regression models were used to detect between group differences. Linear Mixed Models were used to model potential changes over time. RESULTS: This trial was terminated prior to a-priori defined sample size has been reached given low recruitment success as well as high intervention dropout (88%) and study attrition (23%). On average, participants in the intervention group completed M = 2.78 (SD = 3.23) modules. Participants in the waitlist control group barely started one module (M = 0.82, SD = 1.81). The satisfaction with the intervention was low (M = 20.6, SD = 0.88). Participants reported no negative effects attributed to the iCBT. Differences between groups with regard to depression, anxiety, fear of progression and quality of life remained non-significant (p > 0.05). CONCLUSION: This trial failed to recruit a sufficient number of participants. Future work should explore potential pitfalls with regards to the reach and persuasiveness of internet interventions for people living with CAD. The study gives important indications for future studies with regard to the need for new ideas to reach and treat people with CAD and depression.

Study protocol of a randomised controlled trial on SISU, a software agent providing a brief self-help intervention for adults with low psychological well-being.

INTRODUCTION: Only a minority of people living with mental health problems are getting professional help. As digitalisation moves on, the possibility of providing internet/mobile-based interventions (IMIs) arises. One type of IMIs are fully automated conversational software agents (chatbots). Software agents are computer programs that can hold conversations with a human by mimicking a human conversational style. Software agents could deliver low-threshold and cost-effective interventions aiming at promoting psychological well-being in a large number of individuals. The aim of this trial is to evaluate the clinical effectiveness and acceptance of the brief software agent-based IMI SISU in comparison with a waitlist control group. METHODS AND ANALYSIS: Within a two-group randomised controlled trial, a total of 120 adult participants living with low well-being (Well-being Scale/WHO-5) will be recruited in Germany, Austria and Switzerland. SISU is based on therapeutic writing and acceptance and commitment therapy-based principles. The brief intervention consists of three modules. Participants work through the intervention on 3 consecutive days. Assessment takes place before (t1), during (t2) and after (t3) the interaction with SISU, as well as 4 weeks after randomisation (t4). Primary outcome is psychological well-being (WHO-5). Secondary outcomes are emotional well-being (Flourishing Scale), psychological flexibility (Acceptance and Action Questionnaire-II), quality of life (Assessment of Quality of Life -8D), satisfaction with the intervention (Client Satisfaction Questionnaire-8) and side effects (Inventory for the assessment of negative effectsof psychotherapy). Examined mediators and moderators are sociodemographic variables, personality (Big Five Inventory-10), emotion regulation (Emotion Regulation Questionnaire), alexithymia (Toronto Alexithymia Scale-20), centrality of events (Centrality of Events Scale), treatment expectancies (Credibility Expectancy Questionnaire) and technology alliance (Inventory of Technology Alliance-Online Therapy). Data analysis will be based on intention-to-treat principles. SISU guides participants through a 3-day intervention. ETHICS AND DISSEMINATION: This trial has been approved by the ethics committee of the Ulm University (No. 448/18, 18.02.2019). Results will be submitted for publication in a peer-reviewed journal and presented at conferences. TRIAL REGISTRATION: The trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Trials Register (DRKS): DRKS00016799 (date of registration: 25 April 2019). In case of important protocol modifications, trial registration will be updated. This is protocol version number 1.

Associations of depression and diabetes distress with self-management behavior and glycemic control.

OBJECTIVE: To analyze the independent associations of depression and diabetes distress with self-management and glycemic outcome in Type I (T1DM) and Type 2 diabetes (T2DM). METHOD: Six hundred six people with T1DM or T2DM participated in a cross-sectional survey including measures of depression (PHQ-9), diabetes distress (PAID-5), self-management behavior (DSMQ), and glycemic outcome (HbA1c). Structural equation modeling was performed to analyze the independent linear associations (standardized coefficients) between these variables. RESULTS: In those with T1DM (n = 339), both depressive symptoms and diabetes distress were associated with lower self-management (-0.34, p < .001, and -0.16, p = .007, respectively) and thereover (indirectly) with higher HbA1c (0.20, p < .001, and 0.10, p = .016, respectively); direct associations with HbA1c were not observed. In those with T2DM (n = 267), only depressive symptoms were associated with lower self-management (-0.41, p < .001) and thus (indirectly) with higher HbA1c (0.17, p < .001). Diabetes distress, by contrast, was directly associated with higher HbA1c (0.20, p = .003) but not with self-management. CONCLUSIONS: The results are consistent with the hypothesis that depression is linked to less optimal diabetes self-management, thus leading to less optimal glycemic outcome. The associations were relatively consistent across diabetes types. Diabetes distress was additionally associated with higher glycemic levels, suggesting that people with both depression and diabetes distress might have the least optimal outcome. The conclusions are limited by the cross-sectional study design, self-report assessment of behavior, and potential bias arising from questionnaire measures. Further research is needed to support these findings. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Digital interventions in adult mental healthcare settings: recent evidence and future directions.

PURPOSE OF REVIEW: Internet and mobile-based interventions (IMI) can be used as online delivered forms of psychotherapeutic mental health treatments. These interventions can be an effective as well as time and cost-efficient treatment with the potential to scale up mental healthcare. In this review, we map implementation possibilities into routine mental healthcare settings and provide the most recent evidence. RECENT FINDINGS: Fourteen articles on digital mental healthcare approaches published in the last 18 months were included. Despite the limited number, the studies provide evidence for the effectiveness of IMI in treating inpatients and outpatients with various disorders in different mental healthcare settings. IMI were investigated as stand-alone interventions, in combination with other treatment forms (blended-care), or as aftercare. SUMMARY: Although there is encouraging evidence for the effectiveness of IMI in mental healthcare settings, several limitations have to be considered. The small number of studies conducted within the healthcare system, especially with inpatient samples, calls for more collaboration between researchers and clinical practitioners to unravel barriers and develop efficient protocols for the integration into routine care. Nonetheless, IMI are a promising tool for the endeavour of closing the treatment gap and should, therefore, be further explored in varying settings.

Can acute suicidality be predicted by Instagram data? Results from qualitative and quantitative language analyses.

BACKGROUND: Social media has become increasingly important for communication among young people. It is also often used to communicate suicidal ideation. AIMS: To investigate the link between acute suicidality and language use as well as activity on Instagram. METHOD: A total of 52 participants, aged on average around 16 years, who had posted pictures of non-suicidal self-injury on Instagram, and reported a lifetime history of suicidal ideation, were interviewed using Instagram messenger. Of those participants, 45.5% reported suicidal ideation on the day of the interview (acute suicidal ideation). Qualitative text analysis (software ATLAS.ti 7) was used to investigate experiences with expressions of active suicidal thoughts on Instagram. Quantitative text analysis of language use in the interviews and directly on Instagram (in picture captions) was performed using the Linguistic Inquiry and Word Count software. Language markers in the interviews and in picture captions, as well as activity on Instagram were added to regression analyses, in order to investigate predictors for current suicidal ideation. RESULTS: Most participants (80%) had come across expressions of active suicidal thoughts on Instagram and 25% had expressed active suicidal thoughts themselves. Participants with acute suicidal ideation used significantly more negative emotion words (Cohen's d = 0.66, 95% CI: 0.088-1.232) and words expressing overall affect (Cohen's d = 0.57, 95% CI: 0.001-1.138) in interviews. However, activity and language use on Instagram did not predict acute suicidality. CONCLUSIONS: While participants differed with regard to their use of language in interviews, differences in activity and language use on Instagram were not associated with acute suicidality. Other mechanisms of machine learning, like identifying picture content, might be more valuable.

Internet- Based Interventions in Chronic Somatic Disease.

BACKGROUND: Clinical guidelines recommend psychosocial care as an integral part of medical treatment, but access is often limited. Technology-based approaches provide an attractive opportunity to optimize health outcomes and quality of life in people with chronic somatic diseases e.g. by means of Internet- and mobile-based interventions (IMIs). The present article provides an overview on the basics of IMIs, applications and their evidence base for people living with chronic somatic diseases. METHODS: We conducted a selective literature search in the PubMed and Cochrane databases. Reviews which included randomized controlled trials investigating psychological IMIs were discussed pertaining to their relevance for the population described. RESULTS: IMIs lead to a change in unfavorable behavior connected to chronic somatic diseases. IMIs can foster protective factors like balanced physical activity or risk factors like smoking or alcohol consumption. However, studies reveal small effect sizes of d=0.25 for physical activity and an averaged effect size of d=0.20 for smoking and alcohol consumption. Additionally, IMIs can be used for the (co-)treatment of chronic somatic diseases, for instance to increase disease-specific selfefficacy in patients with diabetes (d=0.23). Studies included in meta-analyses are often highly heterogenous and are investigated in research contexts with limited health care services relevance. CONCLUSION: IMIs are potentially effective when aiming at lifestyle changes and supporting medical treatment in people with chronic somatic diseases. However, results are still heterogenous and the evidence base is limited regarding specific settings, compounding the discussion of possible ways of implementing IMIs into our healthcare systems.

Efficacy of a guided internet-based intervention (iSOMA) for somatic symptoms and related distress in university students: study protocol of a randomised controlled trial.

INTRODUCTION: Persistent and distressing somatic symptoms are common in younger age cohorts such as university students. However, the majority does not receive adequate psychosocial care. Internet-based and mobile-based interventions may represent low threshold and effective extensions to reduce somatic and associated mental symptom severity. The planned study aims to investigate the feasibility and efficacy of an internet-based intervention in reducing somatic and psychological symptoms in an international population of university students with somatic symptom burden. METHODS AND ANALYSIS: This parallel two-armed randomised controlled trial evaluates an 8-week guided intervention, including web-based consecutive modules based on cognitive behavioural therapy (CBT) principles against a waitlist control group. Guidance will be provided by trained psychologists with weekly written supportive feedback. As part of the 'Studicare' project, the present study aims to recruit n=154 university students indicating somatic symptom burden at baseline in German-speaking universities. Self-report assessments will take place at baseline and after intervention completion (8, 16 weeks after randomisation). The primary outcome will be the severity of somatic symptoms and associated mental distress. Secondary outcomes include depression, (health) anxiety, disability, intervention satisfaction and adherence. ETHICS AND DISSEMINATION: Ethics approval has been granted. Results from this study will be published in peer-reviewed journals and presented at international conferences. TRIAL REGISTRATION NUMBER: DRKS00014375; Pre-results.

My Sadness - Our Happiness: Writing About Positive, Negative, and Neutral Autobiographical Life Events Reveals Linguistic Markers of Self-Positivity and Individual Well-Being.

Objective: Narratives of autobiographical events contain rich information about an individual's private experience, his/her deepest thoughts, feelings, and emotions. The present study investigates linguistic markers of emotion expression and subjective well-being in adults during one session of positive, negative, and neutral expressive writing. Participants (N = 28 healthy participants, N = 7 adults with depressive symptoms), all native speakers of German were instructed to write expressively about personally relevant autobiographical life events of negative, positive, and neutral content. Methods: Quantitative text analysis was performed to determine the amount of emotional words, first person pronouns (singular vs. plural), and cognitive function words used in positive, negative, and neutral narratives and to examine the potency of these classes of words as linguistic markers of positivity/negativity, self-reference, and cognitive reappraisal. Additionally, the relationship between expressive writing and subjective well-being was explored by assessing changes in self-reported psychosomatic symptoms and in bodily and emotional awareness immediately after positive, negative, and neutral writing. Results: Regarding healthy participants, negative narratives contained significantly more negative emotional words than positive or neutral narratives. However, negative narratives also contained more positive emotional words compared to negative emotional words in positive narratives. Moreover, negative narratives contained more cognitive function words than positive narratives, suggesting that healthy participants tried to reappraise negative experiences while writing about negative personal life events. Positive narratives were characterized by an increased use of positive words and of pronouns of the first person plural ("we"), supporting a positivity bias and an extension of self-reference from first person singular to plural (we-reference) during positive expressive writing. Similarly, writing about neutral events was characterized by a positivity bias. Although based on descriptive analysis only, preferential use of positive words and cognitive function words in negative narratives was absent in participants reporting depressive symptoms. Positive, negative, and neutral expressive writing was accompanied by differential changes in bodily sensations, emotional awareness, and self-reported psychosomatic symptoms in all participants. Discussion: The findings are discussed with respect to previous research, a self-positivity bias, and a universal positivity bias in language use highlighting the relevance of these biases as markers of subjective well-being.