Clinical trial NCT04380909: ROCO - Self-help for People With Psychological Distress Due to the Covid-19 Situation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Adjustment, Psychological
Coronavirus
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient Health Questionnaire (Löwe et al., 2002)
timeFrame: up to 18 weeks
Secondary outcomes:
measure: Suicide Behavior Questionnaire Revised (Glaesmer et al., 2018)
timeFrame: up to 18 weeks
measure: DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)
timeFrame: up to 18 weeks
measure: SF-12: Short Form Health Survey (Ware et al., 1996)
timeFrame: up to 18 weeks
measure: LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)
timeFrame: up to 18 weeks
measure: Berner Verbitterungsinventar Kurzversion (Znoj, 2008)
timeFrame: up to 18 weeks
measure: Emotion regulation skills SEK-27 (Berking & Znoj, 2008)
timeFrame: up to 18 weeks
measure: SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)
timeFrame: up to 18 weeks
measure: UCLA Loneliness Scale (Döring & Bortz, 1993)
timeFrame: up to 18 weeks
measure: Connor-Davidson Resilience Scale (Sarubin et al., 2015)
timeFrame: up to 18 weeks
measure: ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)
timeFrame: at 3 weeks for experimental group and at 6 weeks for waiting control group
measure: SUS: System Usability Scale (Brooke, 1996)
timeFrame: at 3 weeks for experimental group and at 6 weeks for waiting control group
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Universität Bern
Study officials:
affiliation: University of Bern
name: Hansjörg Znoj, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: University of Bern
name: Thomas Berger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.