Project description:BackgroundThere is a need to improve psychotherapeutic approaches to treatment for vulnerable older adults with depression in terms of both clinical practice and health care supply. Against this background, PSY-CARE is testing the feasibility and effectiveness of outpatient psychotherapy for home-living older adults in need of care with depression in Berlin, Germany, and neighboring suburban areas.MethodsIn a two-arm single-center pragmatic randomized controlled trial (RCT), manual-guided outpatient psychotherapy will be compared to brief psychosocial counseling. The study population will be compromised of older adults with clinically significant depressive symptoms who have a long-term care grade, as assessed by the German compulsory state nursing care insurance. In the intervention group, individual cognitive-behavioral psychotherapy tailored to the specific needs of this population will be offered by residential psychotherapists as part of the regular healthcare service. In the active control group, participants will receive individual psychosocial telephone counselling and a self-help guide. The planned sample size is N = 130 (n = 65 participants per group). The reduction of depressive symptoms (primary outcome) as well as the maintaining of activities of daily living, quality of life, and functioning will be assessed with questionnaires provided at baseline, after the end of the intervention and after three months. Feasibility and process evaluation will be conducted qualitatively based on documentation and interviews with psychotherapists, gatekeepers and the participants.DiscussionPSY-CARE investigates the potentials and limitations of providing outpatient psychotherapeutic treatment meeting the demands of vulnerable home-living older adults with depression under the real conditions of the health care system. The study will provide practical implications to improve access to and quality of outpatient psychotherapy for this poorly supplied population.Trial registrationThe trial is registered at ISRCTN55646265 ; February 15, 2019.

Project description:BackgroundHundreds of youth psychotherapy randomized trials have generated scores of helpful empirically supported treatments (ESTs). However, the standardized structure of many ESTs and their focus on a single disorder or homogeneous cluster of problems may not be ideal for clinically referred youths who have comorbidity and whose treatment needs may shift from week to week. This concern has prompted development of flexible transdiagnostic, modular youth psychotherapies. One of these, designed for efficient training and implementation, is FIRST-a transdiagnostic intervention built on five empirically supported principles of change (i.e., feeling calm, increasing motivation, repairing thoughts, solving problems, and trying the opposite) and targeting common internalizing and externalizing youth mental health disorders and problems. FIRST has shown promise in improving youth mental health in three open trials. Now, in a more rigorous test, we seek to (1) conduct a randomized controlled trial comparing FIRST to usual care in real-world clinical practice settings; (2) examine a promising candidate mediator of change-regulation of negative emotions; and (3) explore variables that may influence clinicians' treatment implementation.MethodsThis is an assessor-naïve randomized controlled effectiveness trial in youth outpatient community clinics in New England and Texas. Using double randomization, clinic-employed clinicians and treatment-referred youths (7-15 years old) are independently randomly allocated (1:1) to FIRST or usual care. We aim to recruit 212 youth participants, all referred through normal community pathways, with elevated symptoms of anxiety, depression, conduct problems, or post-traumatic stress. This study will test the effectiveness of FIRST compared to usual care on mental health outcomes, examine whether those outcomes are mediated by regulation of negative emotions, and explore clinician factors that may be associated with FIRST implementation and outcomes. Session recordings are coded to assess treatment fidelity.DiscussionThis study will evaluate the effectiveness of FIRST in youth community mental health settings, relative to the care usually provided in those settings. If FIRST is found to be effective, it could offer an efficient and practical method to increase use of empirically supported treatment principles in real-world practice contexts.Trial registrationNIH Clinical Trials Registry, NCT04725721. Registered 27 January 2021, https://clinicaltrials.gov/ct2/show/study/NCT04725721.

Project description:BackgroundDepression is highly prevalent in the working population and is associated with significant loss of workdays; however, access to evidence-based treatment is limited.ObjectiveThis study evaluated the effectiveness of a Web-based intervention in reducing mild to moderate depression and sickness absence.MethodsIn an open-label randomized controlled trial, participants were recruited from a large-scale statutory health insurance and were assigned to two groups. The intervention group had access to a 12 week Web-based program consisting of structured interactive sessions and therapist support upon request. The wait-list control group had access to unguided Web-based psycho-education. Depressive symptoms were self-assessed at baseline, post-treatment, and follow-up (12 weeks after treatment) using the Patient Health Questionnaire (PHQ-9) and Beck Depression Inventory (BDI-II) as primary outcome measures. Data on sickness absence was retrieved from health insurance records. Intention-to-treat (ITT) analysis and per-protocol (PP) analysis were performed.ResultsOf the 180 participants who were randomized, 88 completed the post-assessment (retention rate: 48.8%, 88/180). ITT analysis showed a significant between-group difference in depressive symptoms during post-treatment in favor of the intervention group, corresponding to a moderate effect size (PHQ-9: d=0.55, 95% CI 0.25-0.85, P<.001, and BDI-II: d=0.41, CI 0.11-0.70, P=.004). PP analysis partially supported this result, but showed a non-significant effect on one primary outcome (PHQ-9: d=0.61, 95% CI 0.15-1.07, P=.04, and BDI-II: d=0.25 95% CI -0.18 to 0.65, P=.37). Analysis of clinical significance using reliable change index revealed that significantly more participants who used the Web-based intervention (63%, 63/100) responded to the treatment versus the control group (33%, 27/80; P<.001). The number needed to treat (NNT) was 4.08. Within both groups, there was a reduction in work absence frequency (IG: -67.23%, P<.001, CG: -82.61%, P<.001), but no statistical difference in sickness absence between groups was found (P=.07).ConclusionsThe Web-based intervention was effective in reducing depressive symptoms among adults with sickness absence. As this trial achieved a lower power than calculated, its results should be replicated in a larger sample. Further validation of health insurance records as an outcome measure for eHealth trials is needed.Trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 02446836; http://www.isrctn.com/ISRCTN02446836 (Archived by WebCite at http://www.webcitation.org/6jx4SObnw).

Project description:BackgroundPeople who self-harm are at high risk for future suicide and often suffer considerable emotional distress. Depression is common among people who self-harm and may be an underlying driver of self-harm behaviour. Self-harm is often repeated, and risk of repetition is highest immediately after an act of self-harm. Readily accessible brief talking therapies show promise in helping people who self-harm, but further evaluation of these approaches is needed. A brief talking therapy intervention for depression and self-harm has been designed for use in a community setting. This mixed methods feasibility study with repeated measures will examine the feasibility and acceptability of the Community Outpatient Psychological Engagement Service for Self-Harm (COPESS) for people with self-harm and depression in the community, compared to routine care.MethodsSixty participants with a history of self-harm within the last six months, who are also currently depressed, will be recruited to take part in a feasibility single-blind randomised controlled trial (RCT). Participants will be randomised 1:1 to receive COPESS plus treatment as usual (TAU) or TAU alone. Recruitment will be via General Practitioners (GP) and self-referral. Assessment of feasibility and acceptability will be assessed via quantitative and qualitative methods including measures of recruitment and retention to the feasibility trial, participants' experience of therapy, completion/completeness of outcome measures at relevant time-points and completion of a service use questionnaire.DiscussionThe results will indicate whether it is feasible to conduct a definitive full trial to determine whether COPESS is a clinically and cost effective intervention for people who self-harm in the community. Qualitative and quantitative data will in addition help identify potential strengths and/or challenges of implementing brief community-based interventions for people who self-harm.Trial registrationNCT04191122 registered 9th December 2019.

Project description:BackgroundOnly 11%-40% of those with a mental disorder in Germany receive treatment. In many cases, face-to-face psychotherapy is not available because of limited resources, such as an insufficient number of therapists in the area. New approaches to improve the German health care system are needed to counter chronification. Web-based interventions have been shown to be effective as stand-alone and add-on treatments to routine practice. Interventions designed for a wide range of mental disorders such as transdiagnostic interventions are needed to make treatment for mental disorders more accessible and thus shorten waiting times and mitigate the chronification of mental health problems. In general, interventions can be differentiated as having either a capitalization (CAP) focus-thus drawing on already existing strengths-or a compensation (COMP) focus-trying to compensate for deficits. Up to now, the effectiveness of transdiagnostic web-based interventions with either a CAP or a COMP focus has not yet been evaluated.ObjectiveThis study is the first to examine the effectiveness of two transdiagnostic web-based interventions: (1) the activation of resilience and drawing on existing strengths (CAP: Res-Up!) and (2) the improvement of emotion regulation (COMP: REMOTION), compared with care as usual (CAU) in routine outpatient psychotherapy.MethodsAdults with at least 1 mental health disorder will be recruited at 4 outpatient centers in Germany. Participants will then be randomized equally into 1 of the 2 intervention groups Res-Up! (CAP) and REMOTION (COMP) or into the control group (CAU). Assessments will be made at baseline (T0), at 6 weeks after treatment start (T1), and at 12 weeks after treatment start (T2). A primary outcome will be symptom severity (Brief Symptom Inventory-18). Secondary outcomes will focus on emotion regulation and resilience.ResultsParticipant recruitment and data collection started in April 2020 and were ongoing as of July 2022. We expect participants to benefit more from the interventions than from the CAU control on the dimensions of symptom severity, resilience, and emotion regulation. Furthermore, we expect to find possible differences between CAP and COMP. The results of the study are expected in 2023.ConclusionsThis randomized controlled trial will compare CAU with the transdiagnostic web-based interventions Res-Up! and REMOTION, and will thus inform future studies concerning the effectiveness of transdiagnostic web-based interventions in routine outpatient psychotherapy.Trial registrationClinicalTrials.gov NCT04352010; https://clinicaltrials.gov/ct2/show/NCT04352010.International registered report identifier (irrid)DERR1-10.2196/41413.

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Effectiveness and acceptance of a web-based depression intervention during waiting time for outpatient psychotherapy: study protocol for a randomized controlled trial.

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Effectiveness and acceptance of a web-based depression intervention during waiting time for outpatient psychotherapy: study protocol for a randomized controlled trial.

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