Comparison of the Working Alliance in Blended Cognitive Behavioral Therapy and Treatment as Usual for Depression in Europe: Secondary Data Analysis of the E-COMPARED Randomized Controlled Trial.

BACKGROUND: Increasing interest has centered on the psychotherapeutic working alliance as a means of understanding clinical change in digital mental health interventions in recent years. However, little is understood about how and to what extent a digital mental health program can have an impact on the working alliance and clinical outcomes in a blended (therapist plus digital program) cognitive behavioral therapy (bCBT) intervention for depression. OBJECTIVE: This study aimed to test the difference in working alliance scores between bCBT and treatment as usual (TAU), examine the association between working alliance and depression severity scores in both arms, and test for an interaction between system usability and working alliance with regard to the association between working alliance and depression scores in bCBT at 3-month assessments. METHODS: We conducted a secondary data analysis of the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment versus Treatment-as-usual) trial, which compared bCBT with TAU across 9 European countries. Data were collected in primary care and specialized services between April 2015 and December 2017. Eligible participants aged 18 years or older and diagnosed with major depressive disorder were randomized to either bCBT (n=476) or TAU (n=467). bCBT consisted of 6-20 sessions of bCBT (involving face-to-face sessions with a therapist and an internet-based program). TAU consisted of usual care for depression. The main outcomes were scores of the working alliance (Working Alliance Inventory-Short Revised-Client [WAI-SR-C]) and depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]) at 3 months after randomization. Other variables included system usability scores (System Usability Scale-Client [SUS-C]) at 3 months and baseline demographic information. Data from baseline and 3-month assessments were analyzed using linear regression models that adjusted for a set of baseline variables. RESULTS: Of the 945 included participants, 644 (68.2%) were female, and the mean age was 38.96 years (IQR 38). bCBT was associated with higher composite WAI-SR-C scores compared to TAU (B=5.67, 95% CI 4.48-6.86). There was an inverse association between WAI-SR-C and PHQ-9 in bCBT (B=-0.12, 95% CI -0.17 to -0.06) and TAU (B=-0.06, 95% CI -0.11 to -0.02), in which as WAI-SR-C scores increased, PHQ-9 scores decreased. Finally, there was a significant interaction between SUS-C and WAI-SR-C with regard to an inverse association between higher WAI-SR-C scores and lower PHQ-9 scores in bCBT (b=-0.030, 95% CI -0.05 to -0.01; P=.005). CONCLUSIONS: To our knowledge, this is the first study to show that bCBT may enhance the client working alliance when compared to evidence-based routine care for depression that services reported offering. The working alliance in bCBT was also associated with clinical improvements that appear to be enhanced by good program usability. Our findings add further weight to the view that the addition of internet-delivered CBT to face-to-face CBT may positively augment experiences of the working alliance. TRIAL REGISTRATION: ClinicalTrials.gov NCT02542891, https://clinicaltrials.gov/study/NCT02542891; German Clinical Trials Register DRKS00006866, https://drks.de/search/en/trial/DRKS00006866; Netherlands Trials Register NTR4962, https://www.onderzoekmetmensen.nl/en/trial/25452; ClinicalTrials.Gov NCT02389660, https://clinicaltrials.gov/study/NCT02389660; ClinicalTrials.gov NCT02361684, https://clinicaltrials.gov/study/NCT02361684; ClinicalTrials.gov NCT02449447, https://clinicaltrials.gov/study/NCT02449447; ClinicalTrials.gov NCT02410616, https://clinicaltrials.gov/study/NCT02410616; ISRCTN Registry ISRCTN12388725, https://www.isrctn.com/ISRCTN12388725?q=ISRCTN12388725&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10; ClinicalTrials.gov NCT02796573, https://classic.clinicaltrials.gov/ct2/show/NCT02796573. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-016-1511-1.

Support after return to alcohol use: a mixed-methods study on how abstinence motivation and app use change after return to alcohol use in an app-based aftercare intervention for individuals with alcohol use disorder.

BACKGROUND: As the return to alcohol use in individuals with alcohol use disorder (AUD) is common during treatment and recovery, it is important that abstinence motivation is maintained after such critical incidences. Our study aims to explore how individuals with AUD participating in an app-based intervention with telephone coaching after inpatient treatment perceived their abstinence motivation after the return to alcohol use, whether their app use behavior was affected and to identify helpful factors to maintain abstinence motivation. METHODS: Using a mixed-methods approach, ten participants from the intervention group of the randomized controlled trial SmartAssistEntz who returned to alcohol use and recorded this in the app Appstinence, a smartphone application with telephone coaching designed for individuals with AUD, were interviewed about their experiences. The interviews were recorded, transcribed and coded using qualitative content analysis. App use behavior was additionally examined by using log data. RESULTS: Of the ten interviewees, seven reported their abstinence motivation increased after the return to alcohol use. Reasons included the reminder of negative consequences of drinking, the desire to regain control of their situation as well as the perceived support provided by the app. App data showed that app use remained stable after the return to alcohol use with an average of 58.70 days of active app use (SD = 25.96, Mdn = 58.50, range = 24-96, IQR = 44.25) after the return to alcohol use which was also indicated by the participants' reported use behavior. CONCLUSIONS: The findings of the study tentatively suggest that the app can provide support to individuals after the return to alcohol use to maintain and increase motivation after the incidence. Future research should (1) focus on specifically enhancing identification of high risk situations and reach during such critical incidences, (2) actively integrate the experience of the return to alcohol use into app-based interventions to better support individuals in achieving their personal AUD behavior change goals, and (3) investigate what type of support individuals might need who drop out of the study and intervention and discontinue app use altogether. TRIAL REGISTRATION: The primary evaluation study is registered in the German Clinical Trials Register (DRKS, registration number DRKS00017700) and received approval of the ethical committee of the Friedrich-Alexander University Erlangen-Nuremberg (193_19 B).

Efficacy of an Internet- and Mobile-Based Intervention for Subclinical Anxiety and Depression (ICare Prevent) with Two Guidance Formats: Results from a Three-Armed Randomized Controlled Trial.

INTRODUCTION: Limited research exists on intervention efficacy for comorbid subclinical anxiety and depressive disorders, despite their common co-occurrence. Internet- and mobile-based interventions (IMIs) are promising to reach individuals facing subclinical symptoms. OBJECTIVE: This study aimed to evaluate the efficacy of a transdiagnostic and self-tailored IMI in reducing subclinical anxiety and depressive symptom severity with either individualized (IG-IMI) or automated (AG-IMI) guidance compared to a waitlist control group with care-as-usual access (WLC). METHODS: Participants included 566 adults with subclinical anxiety (GAD-7 ≥ 5) and/or depressive (CES-D ≥16) symptoms, who did not meet criteria for a full-syndrome depressive or anxiety disorder. In a three-arm randomized clinical trial, participants were randomized to a cognitive behavioral 7-session IMI plus booster session with IG-IMI (n = 186) or AG-IMI (n = 189) or WLC (n = 191). Primary outcomes included observer-rated anxiety (HAM-A) and depressive (QIDS) symptom severity 8 weeks after randomization assessed by blinded raters via telephone. Follow-up outcomes at 6 and 12 months are reported. RESULTS: Symptom severity was significantly lower with small to medium effects in IG-IMI (anxiety: d = 0.45, depression: d = 0.43) and AG-IMI (anxiety: d = 0.31, depression: d = 0.32) compared to WLC. No significant differences emerged between guidance formats in primary outcomes. There was a significant effect in HAM-A after 6 months favoring AG-IMI. On average, participants completed 85.38% of IG-IMI and 77.38% of AG-IMI. CONCLUSIONS: A transdiagnostic, self-tailored IMI can reduce subclinical anxiety and depressive symptom severity, but 12-month long-term effects were absent. Automated guidance holds promise for enhancing the scalability of IMIs in broad prevention initiatives.

Disgust-based approach-avoidance modification training for individuals suffering from elevated stress: A randomized controlled pilot study.

Perceived stress, a global health problem associated with various mental disorders, is assumed to be influenced by dysfunctional beliefs. It can be hypothesized that these beliefs can be modified with the help of approach-avoidance modification trainings (AAMTs). In the present study (conducted 2020-2022), we aimed to clarify whether the efficacy of AAMTs can be enhanced by utilizing the expression of emotions to move AAMT stimuli. For this purpose, we tested the feasibility and acceptability of a new AAMT paradigm in which the expression of disgust is used to move stress-increasing beliefs away from oneself and the expression of positive emotions is used to move stress-reducing beliefs towards oneself (AAMT-DP). Additionally, we explored the therapeutic potential of the AAMT-DP intervention by comparing it to an inactive control condition and to a conventional AAMT in which stimuli are moved by swipe movements (n = 10 in each condition). The primary outcome was perceived stress 1 week after the training as assessed with the Perceived Stress Scale. Findings indicate sufficient feasibility and acceptability of the intervention and that the decrease in perceived stress in the AAMT-DP condition was greater than in the inactive control condition (g = 0.72 [0.10, 1.72]) and than in the swipe control condition (g = 0.64 [0.01, 1.41]). In sum, findings provide preliminary evidence for the feasibility, acceptability, and the therapeutic potential of the AAMT-DP intervention.

Efficacy of a smartphone-based Cognitive Bias Modification program for emotion regulation: A randomized-controlled crossover trial.

Previous research has identified maladaptive emotion regulation as a key factor in psychopathology. Thus, addressing emotion regulation via scalable, low-threshold digital interventions - such as smartphone-based Cognitive Bias Modification (CBM) - holds important therapeutic potential. Using a randomized-controlled crossover trial, we tested the efficacy of an integrated CBM module within the Affect Regulation Training (ART, i.e., CBM-ART) that targeted emotion regulation through elements of appraisal-based and approach avoidance training. Undergraduate students reporting elevated stress were randomized to a one-week active intervention (Mindgames; including psychoeducation, a quiz, and CBM-ART; n = 40), active control training (Emo Shape; including placebo psychoeducation, a quiz, and a placebo swiping task; n = 36) or waitlist (n = 25). Before and after the intervention, we assessed emotion regulation, interpretation bias, stress and depression. We further tested post-training stress reactivity using an anagram task. Results indicated that the active intervention improved negative (OR = 0.35) and positive (OR = 2.40) interpretation biases and symptom measures (d = 0.52-0.87). However, active control training showed attenuated concurrent pre-post changes on interpretation biases (i.e., OR = 0.53 for negative, and OR = 1.49 for positive interpretations) and symptom measures (d = 0.26-0.91). The active intervention was rated positively in terms of acceptability and usability. These findings provide initial evidence for the efficacy and acceptability of an integrated app-based CBM intervention for emotion regulation in reducing interpretation biases and psychopathological symptoms, including stress. However, future studies should disentangle specific mechanisms underlying interventional effects.

A smartphone application to reduce problematic drinking: a feasibility trial.

BACKGROUND: Problematic drinking is common among college students and associated with various somatic and mental health problems. Given significant evidence for the efficacy of smartphone-based interventions and the frequent use of smartphones among college students, it can be assumed that such interventions have great potential to facilitate access to evidence-based interventions for students suffering from problematic drinking. Thus, we developed a brief intervention that combined a counseling session with an app that utilizes approach-avoidance modification training to reduce alcohol consumption. METHODS: To test the feasibility and explore the potential efficacy of the intervention, we conducted a before-after single-arm study with N = 11 participants reportedly engaging in problematic drinking, who were instructed to practice with the app for 14 days. Feasibility was assessed with the System Usability Scale (SUS). Outcomes included the reduction of self-reported problematic drinking behavior, dysfunctional attitudes about alcohol, and craving, as well as implicit associations between alcohol and self during the training period. Additionally, self-reported problematic drinking behavior was assessed at a 4-week follow-up. RESULTS: On average, participants rated app usability on the SUS (possible range: 0 to 100) with M = 84.32 (SD = 6.53). With regard to efficacy, participants reported a significant reduction of problematic drinking behavior (dpre vs. post = 0.91) which was sustained at follow-up (dfollow-up vs. baseline = 1.07). Additionally, participants reported a significant reduction of dysfunctional attitudes about alcohol (dpre vs. post = 1.48). Results revealed no significant changes in craving nor in implicit associations regarding alcohol. CONCLUSIONS: Findings from this feasibility study provide preliminary evidence that smartphone-based interventions might help reduce problematic drinking in college students. Further research needs to replicate these findings with larger samples in randomized controlled trials. TRIAL REGISTRATION: DRKS00014675 (retrospectively registered).

Additive effects of adjunctive app-based interventions for mental disorders - A systematic review and meta-analysis of randomised controlled trials.

Background: It is uncertain whether app-based interventions add value to existing mental health care. Objective: To examine the incremental effects of app-based interventions when used as adjunct to mental health interventions. Methods: We searched PubMed, PsycINFO, Scopus, Web of Science, and Cochrane Library databases on September 15th, 2023, for randomised controlled trials (RCTs) on mental health interventions with an adjunct app-based intervention compared to the same intervention-only arm for adults with mental disorders or respective clinically relevant symptomatology. We conducted meta-analyses on symptoms of different mental disorders at postintervention. PROSPERO, CRD42018098545. Results: We identified 46 RCTs (4869 participants). Thirty-two adjunctive app-based interventions passively or actively monitored symptoms and behaviour, and in 13 interventions, the monitored data were sent to a therapist. We found additive effects on symptoms of depression (g = 0.17; 95 % CI 0.02 to 0.33; k = 7 comparisons), anxiety (g = 0.80; 95 % CI 0.06 to 1.54; k = 3), mania (g = 0.2; 95 % CI 0.02 to 0.38; k = 4), smoking cessation (g = 0.43; 95 % CI 0.29 to 0.58; k = 10), and alcohol use (g = 0.23; 95 % CI 0.08 to 0.39; k = 7). No significant effects were found on symptoms of depression within a bipolar disorder (g = -0.07; 95 % CI -0.37 to 0.23, k = 4) and eating disorders (g = -0.02; 95 % CI -0.44 to 0.4, k = 3). Studies on depression, mania, smoking, and alcohol use had a low heterogeneity between the trials. For other mental disorders, only single studies were identified. Only ten studies had a low risk of bias, and 25 studies reported insufficient statistical power. Discussion: App-based interventions may be used to enhance mental health interventions to further reduce symptoms of depression, anxiety, mania, smoking, and alcohol use. However, the effects were small, except for anxiety, and limited due to study quality. Further high-quality research with larger sample sizes is warranted to better understand how app-based interventions can be most effectively combined with established interventions to improve outcomes.

Noise Robust Recognition of Depression Status and Treatment Response from Speech via Unsupervised Feature Aggregation.

In the presented work, we utilise a noisy dataset of clinical interviews with depression patients conducted over the telephone for the purpose of depression classification and automated detection of treatment response. Compared to most previous studies dealing with depression recognition from speech, our data set does not include a healthy group of subjects that have never been diagnosed with depression. Furthermore, it contains measurements at different time points for individual subjects, making it suitable for machine learning-based detection of treatment response. In our experiments, we make use of an unsupervised feature quantisation and aggregation method achieving 69.2% Unweighted Average Recall (UAR) when classifying whether patients are currently in remission or experiencing a major depressive episode (MDE). The performance of our model matches cutoff-based classification via Hamilton Rating Scale for Depression (HRSD) scores. Finally, we show that using speech samples, we can detect response to treatment with a UAR of 68.1%.

Zero-shot personalization of speech foundation models for depressed mood monitoring.

The monitoring of depressed mood plays an important role as a diagnostic tool in psychotherapy. An automated analysis of speech can provide a non-invasive measurement of a patient's affective state. While speech has been shown to be a useful biomarker for depression, existing approaches mostly build population-level models that aim to predict each individual's diagnosis as a (mostly) static property. Because of inter-individual differences in symptomatology and mood regulation behaviors, these approaches are ill-suited to detect smaller temporal variations in depressed mood. We address this issue by introducing a zero-shot personalization of large speech foundation models. Compared with other personalization strategies, our work does not require labeled speech samples for enrollment. Instead, the approach makes use of adapters conditioned on subject-specific metadata. On a longitudinal dataset, we show that the method improves performance compared with a set of suitable baselines. Finally, applying our personalization strategy improves individual-level fairness.

Sadness-Based Approach-Avoidance Modification Training for Subjective Stress in Adults: Pilot Randomized Controlled Trial.

BACKGROUND: A key vulnerability factor in mental health problems is chronic stress. There is a need for easy-to-disseminate and effective interventions to advance the prevention of stress-related illnesses. App-based stress management trainings can fulfill this need. As subjectively experienced stress may be influenced by dysfunctional beliefs, modifying their evaluations might reduce subjective stress. Approach-avoidance modification trainings (AAMT) can be used to modify stimulus evaluations and are promising candidates for a mobile stress intervention. As the standard training reactions of the AAMT (swiping and joystick motion) have little valence, emotions could be incorporated as approach and avoidance reactions to enhance the effectiveness of AAMTs. OBJECTIVE: We aimed to evaluate the feasibility of a mobile emotion-enhanced AAMT that engages users to display sadness to move stress-enhancing beliefs away and display positive emotions to move stress-reducing beliefs toward themselves (emotion-based AAMT using sadness and positive emotions [eAAMT-SP]). We explored the clinical efficacy of this novel intervention. METHODS: We allocated 30 adult individuals with elevated stress randomly to 1 of 3 conditions (eAAMT-SP, a swipe control condition, and an inactive control condition). We evaluated the feasibility of the intervention (technical problems, adherence, usability, and acceptability). To explore the clinical efficacy of the intervention, we compared pretest-posttest differences in perceived stress (primary clinical outcome) and 3 secondary clinical outcomes (agreement with and perceived helpfulness of dysfunctional beliefs, emotion regulation, and depressive symptoms) among the conditions. RESULTS: The predetermined benchmarks of 50% for intervention completion and 75% for feasibility of the study design (completion of the study design) were met, whereas the cutoff for technical feasibility of the study design (95% of trials without technical errors) was not met. Effect sizes for usability and acceptability were in favor of the eAAMT-SP condition (compared with the swipe control condition; intelligibility of the instructions: g=-0.86, distancing from dysfunctional beliefs: g=0.22, and approaching functional beliefs: g=0.55). Regarding clinical efficacy, the pretest-posttest effect sizes for changes in perceived stress were g=0.80 for the comparison between the eAAMT-SP and inactive control conditions and g=0.76 for the comparison between the eAAMT-SP and swipe control conditions. Effect sizes for the secondary clinical outcomes indicated greater pretest-posttest changes in the eAAMT-SP condition than in the inactive control condition and comparable changes in the swipe control condition. CONCLUSIONS: The findings regarding the feasibility of the intervention were satisfactory except for the technical feasibility of the intervention, which should be improved. The effect sizes for the clinical outcomes provide preliminary evidence for the therapeutic potential of the intervention. The findings suggest that extending the AAMT paradigm through the use of emotions may increase its efficacy. Future research should evaluate the eAAMT-SP in sufficiently powered randomized controlled trials. TRIAL REGISTRATION: German Clinical Trials Registry DRKS00023007; https://drks.de/search/en/trial/DRKS00023007.

Evaluating the feasibility and exploring the efficacy of an emotion-based approach-avoidance modification training (eAAMT) in the context of perceived stress in an adult sample - protocol of a parallel randomized controlled pilot study.

BACKGROUND: Stress levels and thus the risk of developing related physical and mental health conditions are rising worldwide. Dysfunctional beliefs contribute to the development of stress. Potentially, such beliefs can be modified with approach-avoidance modification trainings (AAMT). As previous research indicates that effects of AAMTs are small, there is a need for innovative ways of increasing the efficacy of these interventions. For this purpose, we aim to evaluate the feasibility of the intervention and study design and explore the efficacy of an innovative emotion-based AAMT version (eAAMT) that uses the display of emotions to move stress-inducing beliefs away from and draw stress-reducing beliefs towards oneself. METHODS: We will conduct a parallel randomized controlled pilot study at the Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany. Individuals with elevated stress levels will be randomized to one of eight study conditions (n = 10 per condition) - one of six variants of the eAAMT, an active control intervention (swipe-based AAMT), or an inactive control condition. Participants in the intervention groups will engage in four sessions of 20-30 min (e)AAMT training on consecutive days. Participants in the inactive control condition will complete the assessments via an online tool. Non-blinded assessments will be taken directly before and after the training and 1 week after training completion. The primary outcome will be perceived stress. Secondary outcomes will be dysfunctional beliefs, symptoms of depression, emotion regulation skills, and physiological stress measures. We will compute effect sizes and conduct mixed ANOVAs to explore differences in change in outcomes between the eAAMT and control conditions. DISCUSSION: The study will provide valuable information to improve the intervention and study design. Moreover, if shown to be effective, the approach can be used as an automated smartphone-based intervention. Future research needs to identify target groups benefitting from this intervention utilized either as stand-alone treatment or an add-on intervention that is combined with other evidence-based treatments. TRIAL REGISTRATION: The trial has been registered in the German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS00023007 ; September 7, 2020).

The Effect of Digital Mindfulness Interventions on Depressive, Anxiety, and Stress Symptoms in Pregnant Women: A Systematic Review and Meta-Analysis.

Introduction. Pregnancy is a unique time in a woman's life that can be both exciting and challenging. It is also a period that can be associated with significant stress, anxiety, and depression, which can have negative consequences for both the mother and the baby. Mindfulness interventions are known to be a well-suited treatment and prevention method for psychiatric symptoms in pregnancy, and web-based applications have been explored. We here present an up-to-date systematic review and meta-analysis of randomized-controlled trials to investigate the effect of digital-based mindfulness interventions on depressive, anxiety, and stress symptoms during pregnancy. Methods. The systematic literature search and data extraction was performed by two independent raters. It resulted in 13 eligible studies overall comprising 1373 participants. We conducted random-effects meta-analyses for depressive, anxiety, and stress symptoms after completion of a digital mindfulness intervention (compared to a control group). Results. Digital mindfulness intervention methods were significantly able to reduce depression (g = -0.47, 95% CI [-0.9; -0.09]) and anxiety symptoms (g = -0.41, 95% CI [-0.77; -0.05]), but not stress symptoms. These effects were moderated by the attrition rate (ßDepression = 0.025, pDepression < 0.01; ßAnxiety = 0.022, pAnxiety < 0.01; ßStress = 0.022, pStress < 0.01). Primiparity also had a significant influence on the intervention effect regarding depression symptoms (ß = 0.033, p = 0.024). Conclusions. Digital mindfulness interventions are a promising method to reduce mental health symptoms in pregnant women. We identified certain parameters moderating this effect, for example, primiparity and the attrition rate.

How to promote usage of telehealth interventions for farmers' mental health? A qualitative study on supporting and hindering aspects for acceptance and satisfaction with a personalized telephone coaching for depression prevention.

Low-threshold and remotely delivered preventive interventions, like telephone coaching, are warranted for farmers who experience multiple risk factors for depression, live in underserved areas, and show low help-seeking behavior. Factors facilitating uptake and actual use of effective remote interventions are important to reduce depression disease burden. This study aimed at identifying factors that potentially can influence acceptance of and satisfaction with a telephone coaching in this occupational group.Semi-structured interviews were based on the 'Unified Theory of Acceptance and Use of Technology', the 'Evaluation', and 'Discrepancy' models for satisfaction. Interviews were conducted with 20 of 66 invited participants of a 6-months telephone coaching during an effectiveness or implementation study. Audio-recorded interviews were transcribed and analyzed (deductive-inductive qualitative content analysis). Independent coding by two persons resulted in good agreement (Κ = 0.80). Participants validated results via questionnaire.Overall, 32 supporting (SF) and 14 hindering factors (HF) for acceptance and satisfaction were identified and organized into five dimensions: Coaching result (SF = 9, HF = 3), coach (SF = 9, HF = 1), organization (SF = 5, HF = 2), the telephone as communication medium (SF = 4, HF = 5) and participant characteristics (SF = 5, HF = 3). Most named SFs were 'Flexible appointment arrangement' (n = 19/95 %) and 'low effort' (n = 17/85 %), while most reported HFs were 'lack of visual cues' (n = 12/60 %) and 'social/professional involvement restricts change process' (n = 10/50 %).The perceived changes initiated by coaching, a low effort through telephone conduct, and the indicated personalization were identified as important influencing factors on acceptance and satisfaction based on interviewees' statements. Both may be further enhanced by offering choice and advice for delivery formats (e.g., video-calls) and training of coaches in farm-related issues. Study registration: German Clinical Trial Registrations: DRKS00017078 and DRKS00015655.

Case report for an internet- and mobile-based intervention for internet use disorder.

Background and aims: Internet use disorder (IUD), characterized as the inability to control one's internet use, is associated with reduced quality of life and mental health comorbidities such as depression, substance abuse, or anxiety. Evidence-based treatment options are scarce due to the novelty of the diagnosis. Internet- and mobile-based interventions (IMI) may be an effective means to deliver psychological treatment to individuals with IUD as they address affected individuals in their online setting. This study presents a newly developed IMI for IUD disclosing treatment satisfaction and preliminary effects by exemplifying with a case report. Methods: The case of a female participant with IUD, characterized by an excessive use of social media, is analyzed. The case report follows the CARE guidelines and presents qualitative and quantitative outcomes regarding potential symptom reduction measured by the Internet Addiction Test (IAT) and Compulsive Internet Use Scale (CIUS), treatment satisfaction measured by the Client Satisfaction Questionnaire (CSQ) and feasibility by analyzing participant's written feedback during treatment. Results: The case report shows that internet- and mobile-based interventions may be feasible in supporting an individual in reducing symptoms of IUD as well as depressive symptoms, anxiety and procrastination behavior. Treatment satisfaction was reported as good. Discussion and conclusions: This case report illustrates that IMIs can have the potential to be an easily accessible and possibly effective treatment option for IUD. Case studies on IMIs may provide insights into important mechanisms for symptom change. Further studies are needed to expand our understanding of this diverse disorder to provide adequate treatment. Clinical Trial Registration: https://clinicaltrials.gov/,DRKS00015314.

Hair Cortisol Research in Posttraumatic Stress Disorder - 10 Years of Insights and Open Questions. A Systematic Review.

BACKGROUND: Cortisol is one of the most extensively studied biomarkers in the context of trauma/posttraumatic stress disorder (PTSD). For more than a decade, hair cortisol concentrations (HCC) have been measured in this context, leading to a two-staged dysregulation model. Specifically, an elevated secretion during/immediately after trauma exposure eventually reverts to hyposecretion with increasing time since trauma exposure has been postulated. OBJECTIVE: The aim of our systematic review was to re-evaluate the two-staged secretion model with regard to the accumulated diagnostic, prognostic, and intervention-related evidence of HCC in lifetime trauma exposure and PTSD. Further, we provide an overview of open questions, particularly with re- spect to reporting standards and quality criteria. METHOD: A systematic literature search yielded 5,046 records, of which 31 studies were included. RESULTS: For recent/ongoing (traumatic) stress, the predictions of cortisol hypersecretion could be largely confirmed. However, for the assumed hyposecretion temporally more distal to trauma expo- sure, the results are more ambiguous. As most studies did not report holistic overviews of trauma his- tory and confounding influences, this may largely be attributable to methodological limitations. Data on the prognostic and intervention-related benefits of HCC remain sparse. CONCLUSION: Over the last decade, important insights could be gained about long-term cortisol secretion patterns following lifetime trauma exposure and PTSD. This systematic review integrates these insights into an updated secretion model for trauma/PTSD. We conclude with recommendations for improving HCC research in the context of trauma/PTSD in order to answer the remaining open questions.

Evaluating a multimodal, clinical and work-directed intervention (RTW-PIA) to support sustainable return to work among employees with mental disorders: study protocol of a multicentre, randomised controlled trial.

BACKGROUND: Mental disorders (MDs) are one of the leading causes for workforce sickness absence and disability worldwide. The burden, costs and challenges are enormous for the individuals concerned, employers and society at large. Although most MDs are characterised by a high risk of relapse after treatment or by chronic courses, interventions that link medical-psychotherapeutic approaches with work-directed components to facilitate a sustainable return to work (RTW) are rare. This protocol describes the design of a study to evaluate the (cost-)effectiveness and implementation process of a multimodal, clinical and work-directed intervention, called RTW-PIA, aimed at employees with MDs to achieve sustainable RTW in Germany. METHODS: The study consists of an effectiveness, a health-economic and a process evaluation, designed as a two-armed, multicentre, randomised controlled trial, conducted in German psychiatric outpatient clinics. Sick-listed employees with MDs will receive either the 18-month RTW-PIA treatment in conjunction with care as usual, or care as usual only. RTW-PIA consists of a face-to-face individual RTW support, RTW aftercare group meetings, and web-based aftercare. Assessments will be conducted at baseline and 6, 12, 18 and 24 months after completion of baseline survey. The primary outcome is the employees´ achievement of sustainable RTW, defined as reporting less than six weeks of working days missed out due to sickness absence within 12 months after first RTW. Secondary outcomes include health-related quality of life, mental functioning, RTW self-efficacy, overall job satisfaction, severity of mental illness and work ability. The health-economic evaluation will be conducted from a societal and public health care perspective, as well as from the employer's perspective in a cost-benefit analysis. The design will be supplemented by a qualitative effect evaluation using pre- and post-interviews, and a multimethod process evaluation examining various predefined key process indicators from different stakeholder perspectives. DISCUSSION: By applying a comprehensive, multimethodological evaluation design, this study captures various facets of RTW-PIA. In case of promising results for sustainable RTW, RTW-PIA may be integrated into standard care within German psychiatric outpatient clinics. TRIAL REGISTRATION: The study was prospectively registered with the German Clinical Trials Register ( DRKS00026232 , 1 September 2021).

Internet- and mobile-based psychological interventions for sexual dysfunctions: a systematic review and meta-analysis.

Sexual dysfunctions are highly prevalent and undertreated. Internet- and mobile-based psychological interventions (IMIs) could be a promising addition to close this treatment gap, given their accessibility, anonymity, and scalability. This systematic review and meta-analysis investigated the efficacy of IMIs for sexual dysfunctions. A comprehensive literature search was conducted in August 2021 on randomized controlled trials investigating the effects of IMIs on sexual functioning and satisfaction compared to a control condition. Twelve RCTs with 14 comparisons were reviewed with six IMIs targeting female and six IMIs targeting male sexual dysfunctions and n = 952 participants were evaluated in the meta-analysis. IMIs were significantly more effective than control conditions (k = 11 waitlist control group, k = 3 online discussion board) at post-treatment for female sexual functioning (g = 0.59, CI: 0.28-0.90, I2 = 0%) and satisfaction (g = 0.90, CI: 0.02-1.79, I2 = 82%), and male sexual functioning (g = 0.18, CI: 0.02-0.34, I2 = 0%). No significant effect was found for male sexual satisfaction (g = 0.69, CI: -0.13-1.51, I2 = 88%) with substantial heterogeneity in studies. Most studies showed high dropout, with ten studies indicating some concern of risk of bias, and two studies showing high risk of bias. The results suggest that IMIs can be an effective treatment for sexual dysfunctions, although additional high-quality research is needed. Given the limited availability of specialized treatment for sexual dysfunctions and individual preferences for discrete treatment options, IMIs seem to be a valuable addition to routine care, empowering individuals to promote their sexual health on a guided self-help basis.

Digital prevention of depression for farmers? A qualitative study on participants' experiences regarding determinants of acceptance and satisfaction with a tailored guided internet intervention program.

Introduction: Farmers, forest workers and gardeners have a higher risk of developing depression compared to other occupational populations. As part of the German pilot project "With us in balance", the potential of six guided internet- and mobile-based interventions (IMIs) to prevent depression among their insurants is examined. The IMI program is tailored to various risk factors of depression, individual symptoms, and needs. Although IMIs have been shown to be effective in reducing depressive symptoms, there is little qualitative research about the acceptance of digital preventive IMIs. The aim of this qualitative study is to gain insights into participants' experiences with the guided IMIs by focusing on determinants for acceptance and satisfaction. Methods: Semi-structured interviews were conducted with 22/171 (13 %) intervention group (IG) participants of a randomized controlled trial. The interview guide was developed based on theoretical models of user acceptance (Unified Theory of Acceptance and Use of Technology) and patient satisfaction (evaluation model, discrepancy theory). The interviews were evaluated independently by two coders performing a deductive-inductive content analysis and attaining a substantial level of agreement (K = 0.73). Results: The qualitative analysis revealed 71 determinants for acceptance and satisfaction across ten dimensions: performance expectancy, organisation, e-coach, usability, training content and structure, training usage, training outcome, financing, social influence, and behavioural intention. The most frequently identified drivers for the IMI use include "location independence", "positive relationship to the e-coach" (each n = 19, 86 %), "personal e-coach guidance", "expertise of the e-coach", "target group specific adaptation" (each n = 18, 82 %), "flexibility", "high willingness for renewed participation" (each n = 17, 77 %), "fast and easy availability", "training of health enhancing attitudes and behaviours" and "content with figurative expressions" (each n = 16, 73 %). Discussion: The qualitative findings predominantly suggest the acceptance of and satisfaction with the IMI program for the prevention of depression in famers and related lines of work. Many identified positive drivers are related to the e-coach guidance, which emphasizes its importance in the preventive setting from the perspective of the participants. Nevertheless, some negative aspects have been identified which help to understand potential weaknesses of the IMI program. Participants indicated different needs in terms of IMI content and usage, which points towards the potential benefit of individualisation. The possibility of being able to use IMIs anonymously, flexibly and independently of location might be highly relevant for this specific target group.

Telephone coaching for the prevention of depression in farmers: Results from a pragmatic randomized controlled trial.

INTRODUCTION: Farmers have a high risk for depression (MDD). Preventive measures targeting this often remotely living population might reduce depression burden. The study aimed to evaluate the effectiveness of personalized telephone coaching in reducing depressive symptom severity and preventing MDD in farmers compared to enhanced treatment as usual (TAU + ). METHODS: In a two-armed, pragmatic randomized controlled trial (N = 314) with post-treatment at 6 months, farming entrepreneurs, collaborating family members and pensioners with elevated depressive symptoms (PHQ-9 ≥ 5) were randomized to personalized telephone coaching or TAU + . The coaching was provided by psychologists and consists on average of 13 (±7) sessions a 48 min (±15) over 6 months. The primary outcome was depressive symptom severity (QIDS-SR16). RESULTS: Coaching participants showed a significantly greater reduction in depressive symptom severity compared to TAU + (d = 0.39). Whereas reliable symptom deterioration was significantly lower in the intervention group compared to TAU + , no significant group differences were found for reliable improvement and in depression onset. Further significant effects in favor of the intervention group were found for stress (d = 0.34), anxiety (d = 0.30), somatic symptoms (d = 0.39), burnout risk (d = 0.24-0.40) and quality of life (d = 0.28). DISCUSSION: Limiting, we did not apply an upper cutoff score for depressive symptom severity or controlled for previous MDD episodes, leaving open whether the coaching was recurrence/relapse prevention or early treatment. Nevertheless, personalized telephone coaching can effectively improve mental health in farmers. It could play an important role in intervening at an early stage of mental health problems and reducing disease burden related to MDD. TRIAL REGISTRATION NUMBER AND TRIAL REGISTER: German Clinical Trial Registration: DRKS00015655.

The efficacy of a transdiagnostic emotion regulation skills training in the treatment of binge-eating disorder-Results from a randomized controlled trial.

OBJECTIVES: Deficits in emotion regulation (ER) have been shown to be associated with binge-eating disorder (BED). To further clarify the causal nature of this association, we tested whether systematically enhancing ER skills would reduce symptoms of BED. METHODS: We randomly allocated N = 101 individuals meeting the criteria for BED to a transdiagnostic ER skills training or to a waitlist control condition (WLC). Primary outcome was the reduction in binges during the treatment-vs.-waiting period as assessed with the Eating Disorder Examination (EDE) interview. RESULTS: Mixed-model ANOVAs indicated that the average pre-to-post decrease in binges assessed with the EDE was significantly greater in the ER skills training condition than in the WLC (d = 0.66). These effects were stable over the 6-month follow-up period (d = 0.72). Remission rates at post/follow-up were 34.4/45.0% in the skills training and 7.5/20.0% in the WLC. Additionally, we found a greater reduction in general eating disorder psychopathology, of food consumption in a bogus taste test and of depression in the ER skills training condition. Moreover, the greater reduction in binge-eating episodes in the training condition was (partially) mediated by a greater increase in ER skills. CONCLUSIONS: The findings provide further support for the assumed importance of deficits in ER as a maintaining factor and, hence, as a target in the treatment of BED. As ER skills trainings have been shown to also reduce other kinds of psychopathology, they might be considered a promising transdiagnostic add-on component to disorder-specific interventions.