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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04380909
Acronym
ROCO
Enrollment
107
Registered
2020-05-08
Start date
2020-05-06
Completion date
2021-07-29
Last updated
2021-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjustment, Psychological, Coronavirus, Psychological Distress

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.

Interventions

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.

Sponsors

University of Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
Patient Health Questionnaire (Löwe et al., 2002)up to 18 weeks9-item questionnaire assessing depressive symptoms

Secondary

MeasureTime frameDescription
DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)up to 18 weeks21-item questionnaire assessing depression, anxiety and stress symptoms
SF-12: Short Form Health Survey (Ware et al., 1996)up to 18 weeks12-item questionnaire assessing various aspects of well-being
LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)up to 18 weeks10-item questionnaire assessing optimism and pessimism
Berner Verbitterungsinventar Kurzversion (Znoj, 2008)up to 18 weeks6-item questionnaire assessing embitterment
Emotion regulation skills SEK-27 (Berking & Znoj, 2008)up to 18 weeks27-item questionnaire assessing emotion regulation skills
Suicide Behavior Questionnaire Revised (Glaesmer et al., 2018)up to 18 weeks4-item questionnaire assessing suicidal ideation
UCLA Loneliness Scale (Döring & Bortz, 1993)up to 18 weeks9-item questionnaire assessing loneliness
Connor-Davidson Resilience Scale (Sarubin et al., 2015)up to 18 weeks10-item questionnaire assessing resilience
ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)at 3 weeks for experimental group and at 6 weeks for waiting control group8-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 group10-item questionnaire assessing usability of an online-program
SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)up to 18 weeks10-item questionnaire assessing general self-efficacy

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026