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

Sponsor

University of Bern (Other)

Overall Status

Completed

CT.gov ID

NCT04380909

Collaborator

(none)

107

Enrollment

Location

Arms

14.8

Actual Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychological Distress Adjustment, Psychological Coronavirus	Behavioral: Internet-based self-help Behavioral: Internet-based self-help after 3 weeks	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

107 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

May 6, 2020

Actual Primary Completion Date :

Jul 29, 2021

Actual Study Completion Date :

Jul 29, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Suicide Behavior Questionnaire Revised (Glaesmer et al., 2018) [up to 18 weeks]
4-item questionnaire assessing suicidal ideation
DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995) [up to 18 weeks]
21-item questionnaire assessing depression, anxiety and stress symptoms
SF-12: Short Form Health Survey (Ware et al., 1996) [up to 18 weeks]
12-item questionnaire assessing various aspects of well-being
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
Emotion regulation skills SEK-27 (Berking & Znoj, 2008) [up to 18 weeks]
27-item questionnaire assessing emotion regulation skills
SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003) [up to 18 weeks]
10-item questionnaire assessing general self-efficacy
UCLA Loneliness Scale (Döring & Bortz, 1993) [up to 18 weeks]
9-item questionnaire assessing loneliness
Connor-Davidson Resilience Scale (Sarubin et al., 2015) [up to 18 weeks]
10-item questionnaire assessing resilience
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universität Bern	Bern		Switzerland	3012

Sponsors and Collaborators

University of Bern

Investigators

Study Director: Hansjörg Znoj, Prof. Dr., University of Bern
Principal Investigator: Thomas Berger, Prof. Dr., University of Bern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Bern

ClinicalTrials.gov Identifier:

NCT04380909

Other Study ID Numbers:

2020-00990

First Posted:

May 8, 2020

Last Update Posted:

Aug 24, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronavirus Infections

Study Results

No Results Posted as of Aug 24, 2021