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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2021
Source University of Bern
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
Internet-based self-help
Six cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of psychological distress due to the Covid-19 situation.
Internet-based self-help after 3 weeks
Six cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of psychological distress due to the Covid-19 situation.

Locations

Country Name City State
Switzerland Universität Bern Bern

Sponsors (1)

Lead Sponsor Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

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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