Psychological Distress Clinical Trial
— ROCOOfficial title:
Randomized Controlled Trial (RCT) to Evaluate the Efficacy of an Internet-based Self-help Program for People With Psychological Distress Due to Covid-19
NCT number | NCT04380909 |
Other study ID # | 2020-00990 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 6, 2020 |
Est. completion date | July 29, 2021 |
Verified date | August 2021 |
Source | University of Bern |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 107 |
Est. completion date | July 29, 2021 |
Est. primary completion date | July 29, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Universität Bern | Bern |
Lead Sponsor | Collaborator |
---|---|
University of Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Health Questionnaire (Löwe et al., 2002) | 9-item questionnaire assessing depressive symptoms | up to 18 weeks | |
Secondary | Suicide Behavior Questionnaire Revised (Glaesmer et al., 2018) | 4-item questionnaire assessing suicidal ideation | up to 18 weeks | |
Secondary | DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995) | 21-item questionnaire assessing depression, anxiety and stress symptoms | up to 18 weeks | |
Secondary | SF-12: Short Form Health Survey (Ware et al., 1996) | 12-item questionnaire assessing various aspects of well-being | up to 18 weeks | |
Secondary | LOT-R: Revised Life Orientation Test (Herzberg et al., 2006) | 10-item questionnaire assessing optimism and pessimism | up to 18 weeks | |
Secondary | Berner Verbitterungsinventar Kurzversion (Znoj, 2008) | 6-item questionnaire assessing embitterment | up to 18 weeks | |
Secondary | Emotion regulation skills SEK-27 (Berking & Znoj, 2008) | 27-item questionnaire assessing emotion regulation skills | up to 18 weeks | |
Secondary | SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003) | 10-item questionnaire assessing general self-efficacy | up to 18 weeks | |
Secondary | UCLA Loneliness Scale (Döring & Bortz, 1993) | 9-item questionnaire assessing loneliness | up to 18 weeks | |
Secondary | Connor-Davidson Resilience Scale (Sarubin et al., 2015) | 10-item questionnaire assessing resilience | up to 18 weeks | |
Secondary | 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 | |
Secondary | 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 |
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