ROCO - Self-help for People With Psychological Distress Due to the Covid-19 Situation

Study Overview
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Brief Summary
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As part of the ROCO project, the University of Bern is investigating an online self-help program for people who are psychologically distressed due to the situation surrounding Covid-19. The ROCO program offers support in overcoming this psychological distress. ROCO stands for a 3-week online self-help program comprising 6 modules. The aim of the study is to investigate the efficacy of an online self-help intervention for people with psychological distress due to the situation surrounding Covid-19. All participants will be randomized to one of two groups: The first group receives direct access to the online self-help intervention and the second group is a waiting control group that receives access to the program 3 weeks later. In both conditions additional care or treatment is allowed. There are 4 assessments, which all take place online: baseline, post assessment (after 3 weeks) and two follow-up assessments (after 6 and 18 weeks). All participants from both groups are asked to fill out all assessments.

Official Title
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Randomized Controlled Trial (RCT) to Evaluate the Efficacy of an Internet-based Self-help Program for People With Psychological Distress Due to Covid-19

Conditions
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Coronavirus, Psychological Distress, Adjustment, Psychological

Intervention / Treatment
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* Behavioral: Internet-based self-help
* Behavioral: Internet-based self-help after 3 weeks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years old Give a declaration of consent to participate in the study Have access to the internet Understand and master the German language to the degree that they understand the contents and instructions of the study Exceed a cut-off value of 4 points on the Brief Patient Health Questionnaire (PHQ-9; Löwe, Spitzer, Zipfel, & Herzog, 2002) Be able to specify an emergency address in the event of an acute crisis Exclusion Criteria: Suicidal tendencies (SBQ-R Score ≥ 8) Existence of a known diagnosis of a psychotic or bipolar disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based self-help<br>The self-help program consists of six text- and video-based modules. All participants in this group receive immediate access to the self-help program. The program's self-management approach does not provide for regular support from a specialist. However, participants can contact the study team if they need or want additional help. | Behavioral: Internet-based self-help<br>* Six cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of psychological distress due to the Covid-19 situation.<br>|
| Other: Waiting control group<br>Access to internet-based intervention after 3 weeks. | Behavioral: Internet-based self-help after 3 weeks<br>* Six cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of psychological distress due to the Covid-19 situation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire (Löwe et al., 2002) | 9-item questionnaire assessing depressive symptoms | up to 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicide Behavior Questionnaire Revised (Glaesmer et al., 2018) | 4-item questionnaire assessing suicidal ideation | up to 18 weeks | 
| DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995) | 21-item questionnaire assessing depression, anxiety and stress symptoms | up to 18 weeks | 
| SF-12: Short Form Health Survey (Ware et al., 1996) | 12-item questionnaire assessing various aspects of well-being | up to 18 weeks | 
| LOT-R: Revised Life Orientation Test (Herzberg et al., 2006) | 10-item questionnaire assessing optimism and pessimism | up to 18 weeks | 
| Berner Verbitterungsinventar Kurzversion (Znoj, 2008) | 6-item questionnaire assessing embitterment | up to 18 weeks | 
| Emotion regulation skills SEK-27 (Berking & Znoj, 2008) | 27-item questionnaire assessing emotion regulation skills | up to 18 weeks | 
| SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003) | 10-item questionnaire assessing general self-efficacy | up to 18 weeks | 
| UCLA Loneliness Scale (Döring & Bortz, 1993) | 9-item questionnaire assessing loneliness | up to 18 weeks | 
| Connor-Davidson Resilience Scale (Sarubin et al., 2015) | 10-item questionnaire assessing resilience | up to 18 weeks | 
| ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982) | 8-item questionnaire assessing content with an online-program | at 3 weeks for experimental group and at 6 weeks for waiting control group | 
| SUS: System Usability Scale (Brooke, 1996) | 10-item questionnaire assessing usability of an online-program | at 3 weeks for experimental group and at 6 weeks for waiting control group |