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

Psychological Distress Clinical Trial

— ROCO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04380909
• Other study ID #: 2020-00990
• Status: Completed
• Phase: N/A
• Start date: May 6, 2020
• Est. completion date: July 29, 2021

Study information

• Verified date: August 2021
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: July 29, 2021
• Est. primary completion date: July 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adjustment, Psychological
• Coronavirus
• Coronavirus Infections
• Psychological Distress

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Universität Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire (Löwe et al., 2002)	9-item questionnaire assessing depressive symptoms	up to 18 weeks
Secondary	Suicide Behavior Questionnaire Revised (Glaesmer et al., 2018)	4-item questionnaire assessing suicidal ideation	up to 18 weeks
Secondary	DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)	21-item questionnaire assessing depression, anxiety and stress symptoms	up to 18 weeks
Secondary	SF-12: Short Form Health Survey (Ware et al., 1996)	12-item questionnaire assessing various aspects of well-being	up to 18 weeks
Secondary	LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)	10-item questionnaire assessing optimism and pessimism	up to 18 weeks
Secondary	Berner Verbitterungsinventar Kurzversion (Znoj, 2008)	6-item questionnaire assessing embitterment	up to 18 weeks
Secondary	Emotion regulation skills SEK-27 (Berking & Znoj, 2008)	27-item questionnaire assessing emotion regulation skills	up to 18 weeks
Secondary	SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)	10-item questionnaire assessing general self-efficacy	up to 18 weeks
Secondary	UCLA Loneliness Scale (Döring & Bortz, 1993)	9-item questionnaire assessing loneliness	up to 18 weeks
Secondary	Connor-Davidson Resilience Scale (Sarubin et al., 2015)	10-item questionnaire assessing resilience	up to 18 weeks
Secondary	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
Secondary	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