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

Not Applicable

Completed

• Conditions: Adjustment, Psychological; Coronavirus; Psychological Distress
• Interventions: Behavioral: Internet-based self-help; Behavioral: Internet-based self-help after 3 weeks

• Registration Number: NCT04380909
• Lead Sponsor: University of Bern

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-06
• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-08
• Primary Completion: 2021-07-29
• Study Completion: 2021-07-29
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet-based self-help	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.
Waiting control group	Internet-based self-help after 3 weeks	Access to internet-based intervention after 3 weeks.

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (Löwe et al., 2002)	up to 18 weeks	9-item questionnaire assessing depressive symptoms

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universität Bern; 🇨🇭 Bern, Switzerland