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Using a transdiagnostic, psychodynamic online self-help intervention to maintain inpatient psychosomatic treatment effects: Study protocol of a feasibility study.

ABSTRACT: Background:Online self-help interventions have proven to be effective in treating various specific mental disorders, mainly depression and anxiety. Knowledge regarding their acceptance, efficacy, and usefulness in addition to inpatient or outpatient psychotherapy is limited. Therefore, we plan to evaluate an affect-focused, transdiagnostic, psychodynamic online self-help intervention following inpatient psychotherapy for mixed diagnoses in a feasibility study to determine acceptance, satisfaction, and preliminary estimates of efficacy. Methods:The intervention is based on the book "Living Like You Mean It" by Ronald J. Frederick (2009) and the Swedish adaption by Johansson and colleagues (2013). The book was translated into German and thoroughly revised using parts of the Swedish adaption and additional tasks from their intervention. In a pilot phase, corrections concerning comprehensibility of the content and exercises were made based on patient's feedback. In the second step, we developed a website presenting the German adaption in eight units. In the third step, at least N = 66 patients from the Department of Psychosomatic Medicine and Psychotherapy will be recruited for a feasibility study. Patients are randomized into two groups. The intervention group (IG) will receive ten weeks of access to the online self-help intervention together with weekly therapeutic feedback on their progress. The wait-list control group (WLC) will receive access to the intervention for ten weeks as well, but without therapeutic feedback and with a ten-week delay. We will conduct assessments at the beginning of the intervention of the IG (T0), the end of the intervention of the IG (T1), two months later (only IG, T2), and at the end of the intervention of the WLC (T3). The primary outcome is satisfaction with the treatment as measured by the ZUF-8 at T1 and T3 respectively. Secondary outcome measures include emotional competence, depression, anxiety, and quality of life. Conclusion:We expect insight into the usefulness and acceptance of an online self-help intervention used to maintain inpatient treatment effects. Furthermore, we await both groups to benefit from the participation in the intervention. Pre- post and between subject differences will be used as estimate effect sizes to calculate the necessary sample size for a larger efficacy trial.

SUBMITTER: Becker J

PROVIDER: S-EPMC6096314 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Mental disorders have become a major health issue, and a substantial number of afflicted individuals do not get appropriate treatment. Web-based interventions are promising supplementary tools for improving health care for patients with mental disorders, as they can be delivered at low costs and used independently of time and location. Although psychodynamic treatments are used frequently in the face-to-face setting, there has been a paucity of studies on psychodynamic Web-based self-help interventions. OBJECTIVE:The objective of this study was to determine the feasibility and preliminary efficacy of a transdiagnostic affect-focused psychodynamic Web-based self-help intervention designed to increase emotional competence of patients with mental disorders. METHODS:A total of 82 psychotherapy inpatients with mixed diagnoses were randomized into two groups. Following discharge, the intervention group (IG) got access to a guided version of the intervention for 10 weeks. After a waiting period of 10 weeks, the wait-list control group (WLCG) got access to an unguided version of the intervention. We reported the assessments at the beginning (T0) and at the end of the intervention, resp. the waiting period (T1). The primary outcome was satisfaction with the treatment at T1. Secondary outcome measures included emotional competence, depression, anxiety, and quality of life. Statistical analyses were performed with descriptive statistics (primary outcome) and analysis of covariance; a repeated measurement analysis of variance was used for the secondary outcomes. Effect sizes were calculated using Cohen d and data were analyzed as per protocol, as well as intention-to-treat (ITT). RESULTS:Patients were chronically ill, diagnosed with multiple diagnoses, most frequently with depression (84%, 58/69), anxiety (68%, 47/69), personality disorder (38%, 26/69), and depersonalization-derealization disorder (22%, 15/69). A majority of the patients (86%, 36/42) logged into the program, of which 86% (31/36) completed the first unit. Satisfaction with the units mastered was rated as good (52%, 16/31) and very good (26%, 9/31). However, there was a steady decline of participation over the course of the program; only 36% of the participants (13/36) participated throughout the trial completing at least 50% of the sessions. According to the ITT analysis, participants improved statistically significantly and with moderate effect sizes (Cohen d) compared with the WLCG regarding depression (d=0.60), quality of life (d=0.53), and emotional competence (d=0.49). Effects were considerably stronger for the completers with respect to depression (d=1.33), quality of life (d=0.83), emotional competence (d=0.68), and general anxiety (d=0.62). CONCLUSIONS:Although overall program satisfaction and benefit of the program were favorable with respect to the indicators of emotional disorders, the rate of completion was low. Our findings point to the need to target the intervention more specifically to the needs and capabilities of participants and to the context of the intervention. TRIAL REGISTRATION:Clinicaltrials.gov NCT02671929; https://clinicaltrials.gov/ct2/show/NCT02671929 (Archived by WebCite at http://www.webcitation.org/6ntWg1yWb).

Project description:ObjectiveTo explore the feasibility of a dedicated online youth mental health help-seeking intervention and to evaluate using a randomised controlled trial (RCT) study design in order to identify any modifications needed before commencement of the full-scale RCT.DesignA pilot RCT with 1:1 randomisation to either the intervention or comparison arm.SettingAn online study conducted Australia-wide.Participants18-25?year olds living in Australia were recruited via social media.InterventionLink is a dedicated online mental health help-seeking navigation tool that matches user's mental health issues, severity and service-type preferences (online, phone and face-to-face) with appropriate youth-friendly services. The comparison arm was usual help-seeking strategies with a link to Google.com.Main outcome measuresThe primary outcome was the number of acceptability and feasibility criteria successfully met. Intervention and study design acceptability and feasibility were assessed by nine criteria. Secondary outcomes, via online surveys (at baseline, 1?week and 1?month) measured service use, help-seeking intentions, psychological distress, barriers to help-seeking, attitudes towards mental health help-seeking, mental health literacy, satisfaction and trust.ResultsFifty-one participants were randomised (intervention: n=24; comparison: n=27). Three out of four of the intervention and two out of five of the study design criteria were met. Unmet criteria could be addressed by modifications to the study design. Qualitative analysis demonstrated that Link was useful to participants and may have increased their positive experiences towards help-seeking. There were no observable differences between arms in any outcome measures and no harms were detected.ConclusionGenerally, the Link intervention and study design were acceptable and feasible with modifications suggested for the four out of nine unmet criteria. The main trial will hence have shorter surveys and a simpler recruitment process, use positive affect as the primary outcome and will not link to Google.com for the comparison arm.Trial registration numberAustralian New Zealand Clinical Trials Registry, ACTRN12614000386639.

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Using a transdiagnostic, psychodynamic online self-help intervention to maintain inpatient psychosomatic treatment effects: Study protocol of a feasibility study.

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