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

NCT04380909 | Completed DMC

• 1 other identifier: 2020-00990
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Distress; Adjustment, Psychological; Coronavirus

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire (Löwe et al., 2002)

  9-item questionnaire assessing depressive symptoms

  up to 18 weeks

Secondary Outcomes (11)

• Suicide Behavior Questionnaire Revised (Glaesmer et al., 2018)

  up to 18 weeks

• DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)

  up to 18 weeks

• SF-12: Short Form Health Survey (Ware et al., 1996)

  up to 18 weeks

• LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)

  up to 18 weeks

• Berner Verbitterungsinventar Kurzversion (Znoj, 2008)

  up to 18 weeks

Study Arms (2)

Internet-based self-help

EXPERIMENTAL

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

Waiting control group

OTHER

Access to internet-based intervention after 3 weeks.

Behavioral: Internet-based self-help after 3 weeks

Interventions

Internet-based self-help BEHAVIORAL

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

Internet-based self-help after 3 weeks BEHAVIORAL

Six cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of psychological distress due to the Covid-19 situation.

Waiting control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Suicidal tendencies (SBQ-R Score ≥ 8)
• Existence of a known diagnosis of a psychotic or bipolar disorder

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

Universität Bern

Bern, 3012, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 33648555 DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Hansjörg Znoj, Prof. Dr.

  University of Bern

  STUDY DIRECTOR

• Thomas Berger, Prof. Dr.

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 8, 2020
• Study Start: May 6, 2020
• Primary Completion: July 29, 2021
• Study Completion: July 29, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)