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

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

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 Overview

• Status: Completed
• Conditions: Psychological Distress; Coronavirus; Adjustment, Psychological
• Intervention / Treatment: Behavioral: Internet-based self-help; Behavioral: Internet-based self-help after 3 weeks

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3012
    • Universität Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Other: Waiting control group; Access to internet-based intervention after 3 weeks.	Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Bern
• Investigators: Study Director: Hansjörg Znoj, Prof. Dr., University of Bern

Publications and helpful links

General Publications

• Brog NA, Hegy JK, Berger T, Znoj H. An internet-based self-help intervention for people with psychological distress due to COVID-19: study protocol for a randomized controlled trial. Trials. 2021 Mar 1;22(1):171. doi: 10.1186/s13063-021-05089-9.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2020
• Primary Completion (Actual): July 29, 2021
• Study Completion (Actual): July 29, 2021

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: 2020-00990

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No