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CompletedNCT04380909ROCOUpdated Aug 24, 2021

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

An interventional study of Internet-based self-help and Internet-based self-help after 3 weeks in Psychological Distress, Adjustment, Psychological and Coronavirus, sponsored by University of Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-24.

Sponsored by University of Bern · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
107
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Psychological Distress
  • Adjustment, Psychological
  • Coronavirus
03

In context

Coronavirus Infections

929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.

This study's enrollment of 107 is close to the median of 107 across 541 interventional studies indexed under Coronavirus Infections.

Browse Coronavirus Infections studies →

Lead sponsor

University of Bern is the lead sponsor of 207 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Suicidal tendencies (SBQ-R Score ≥ 8)
  • Existence of a known diagnosis of a psychotic or bipolar disorder
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
107 participants (actual)

Study arms

  • 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

  • Other
    Waiting control group

    Access to internet-based intervention after 3 weeks.

    Behavioral: Internet-based self-help after 3 weeks

Interventions

  • BehavioralInternet-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.

  • BehavioralInternet-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.

06

What researchers measure

Primary outcomes

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

    9-item questionnaire assessing depressive symptoms

    Time frame: up to 18 weeks

Secondary outcomes

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

    4-item questionnaire assessing suicidal ideation

    Time frame: up to 18 weeks

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

    21-item questionnaire assessing depression, anxiety and stress symptoms

    Time frame: up to 18 weeks

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

    12-item questionnaire assessing various aspects of well-being

    Time frame: up to 18 weeks

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

    10-item questionnaire assessing optimism and pessimism

    Time frame: up to 18 weeks

  5. Berner Verbitterungsinventar Kurzversion (Znoj, 2008)

    6-item questionnaire assessing embitterment

    Time frame: up to 18 weeks

  6. Emotion regulation skills SEK-27 (Berking & Znoj, 2008)

    27-item questionnaire assessing emotion regulation skills

    Time frame: up to 18 weeks

  7. SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)

    10-item questionnaire assessing general self-efficacy

    Time frame: up to 18 weeks

  8. UCLA Loneliness Scale (Döring & Bortz, 1993)

    9-item questionnaire assessing loneliness

    Time frame: up to 18 weeks

  9. Connor-Davidson Resilience Scale (Sarubin et al., 2015)

    10-item questionnaire assessing resilience

    Time frame: up to 18 weeks

  10. ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)

    8-item questionnaire assessing content with an online-program

    Time frame: at 3 weeks for experimental group and at 6 weeks for waiting control group

  11. SUS: System Usability Scale (Brooke, 1996)

    10-item questionnaire assessing usability of an online-program

    Time frame: at 3 weeks for experimental group and at 6 weeks for waiting control group

07

Study locations

1 site
  • Universität Bern
    Bern, 3012, Switzerland
08

References and documents

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. PubMed 33648555 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04380909
Lead sponsor
University of Bern
Responsible party
Sponsor
First posted
May 8, 2020
Start date
May 6, 2020
Primary completion
Jul 29, 2021
Completion
Jul 29, 2021
Last update
Aug 24, 2021

Study contacts

Hansjörg Znoj, Prof. Dr.
study director · University of Bern
Thomas Berger, Prof. Dr.
principal investigator · University of Bern

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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