Randomized Controlled Trial (RCT) to Evaluate the Efficacy of an Internet-based Self-help Program for People With Psychological Distress Due to Covid-19
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Bern
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- Patient Health Questionnaire (Löwe et al., 2002)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Waiting control group
Access to internet-based intervention after 3 weeks.
Intervention: Internet-based self-help after 3 weeks (Behavioral)
Internet-based self-help
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.
Intervention: Internet-based self-help (Behavioral)
Outcomes
Primary Outcomes
Patient Health Questionnaire (Löwe et al., 2002)
Time Frame: up to 18 weeks
9-item questionnaire assessing depressive symptoms
Secondary Outcomes
- DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)(up to 18 weeks)
- UCLA Loneliness Scale (Döring & Bortz, 1993)(up to 18 weeks)
- Suicide Behavior Questionnaire Revised (Glaesmer et al., 2018)(up to 18 weeks)
- ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)(at 3 weeks for experimental group and at 6 weeks for waiting control group)
- LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)(up to 18 weeks)
- Berner Verbitterungsinventar Kurzversion (Znoj, 2008)(up to 18 weeks)
- SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)(up to 18 weeks)
- Connor-Davidson Resilience Scale (Sarubin et al., 2015)(up to 18 weeks)
- SF-12: Short Form Health Survey (Ware et al., 1996)(up to 18 weeks)
- SUS: System Usability Scale (Brooke, 1996)(at 3 weeks for experimental group and at 6 weeks for waiting control group)
- Emotion regulation skills SEK-27 (Berking & Znoj, 2008)(up to 18 weeks)