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

Primary Purpose

Psychological Distress, Adjustment, Psychological, Coronavirus

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Internet-based self-help
Internet-based self-help after 3 weeks
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychological Distress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universität Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Internet-based self-help

Waiting control group

Arm Description

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.

Access to internet-based intervention after 3 weeks.

Outcomes

Primary Outcome Measures

Patient Health Questionnaire (Löwe et al., 2002)
9-item questionnaire assessing depressive symptoms

Secondary Outcome Measures

Suicide Behavior Questionnaire Revised (Glaesmer et al., 2018)
4-item questionnaire assessing suicidal ideation
DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)
21-item questionnaire assessing depression, anxiety and stress symptoms
SF-12: Short Form Health Survey (Ware et al., 1996)
12-item questionnaire assessing various aspects of well-being
LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)
10-item questionnaire assessing optimism and pessimism
Berner Verbitterungsinventar Kurzversion (Znoj, 2008)
6-item questionnaire assessing embitterment
Emotion regulation skills SEK-27 (Berking & Znoj, 2008)
27-item questionnaire assessing emotion regulation skills
SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)
10-item questionnaire assessing general self-efficacy
UCLA Loneliness Scale (Döring & Bortz, 1993)
9-item questionnaire assessing loneliness
Connor-Davidson Resilience Scale (Sarubin et al., 2015)
10-item questionnaire assessing resilience
ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)
8-item questionnaire assessing content with an online-program
SUS: System Usability Scale (Brooke, 1996)
10-item questionnaire assessing usability of an online-program

Full Information

First Posted
May 7, 2020
Last Updated
August 23, 2021
Sponsor
University of Bern
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1. Study Identification

Unique Protocol Identification Number
NCT04380909
Brief Title
ROCO - Self-help for People With Psychological Distress Due to the Covid-19 Situation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 6, 2020 (Actual)
Primary Completion Date
July 29, 2021 (Actual)
Study Completion Date
July 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Distress, Adjustment, Psychological, Coronavirus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-based self-help
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting control group
Arm Type
Other
Arm Description
Access to internet-based intervention after 3 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based self-help
Intervention Description
Six cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of psychological distress due to the Covid-19 situation.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based self-help after 3 weeks
Intervention Description
Six cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of psychological distress due to the Covid-19 situation.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire (Löwe et al., 2002)
Description
9-item questionnaire assessing depressive symptoms
Time Frame
up to 18 weeks
Secondary Outcome Measure Information:
Title
Suicide Behavior Questionnaire Revised (Glaesmer et al., 2018)
Description
4-item questionnaire assessing suicidal ideation
Time Frame
up to 18 weeks
Title
DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)
Description
21-item questionnaire assessing depression, anxiety and stress symptoms
Time Frame
up to 18 weeks
Title
SF-12: Short Form Health Survey (Ware et al., 1996)
Description
12-item questionnaire assessing various aspects of well-being
Time Frame
up to 18 weeks
Title
LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)
Description
10-item questionnaire assessing optimism and pessimism
Time Frame
up to 18 weeks
Title
Berner Verbitterungsinventar Kurzversion (Znoj, 2008)
Description
6-item questionnaire assessing embitterment
Time Frame
up to 18 weeks
Title
Emotion regulation skills SEK-27 (Berking & Znoj, 2008)
Description
27-item questionnaire assessing emotion regulation skills
Time Frame
up to 18 weeks
Title
SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)
Description
10-item questionnaire assessing general self-efficacy
Time Frame
up to 18 weeks
Title
UCLA Loneliness Scale (Döring & Bortz, 1993)
Description
9-item questionnaire assessing loneliness
Time Frame
up to 18 weeks
Title
Connor-Davidson Resilience Scale (Sarubin et al., 2015)
Description
10-item questionnaire assessing resilience
Time Frame
up to 18 weeks
Title
ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)
Description
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
Title
SUS: System Usability Scale (Brooke, 1996)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hansjörg Znoj, Prof. Dr.
Organizational Affiliation
University of Bern
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thomas Berger, Prof. Dr.
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universität Bern
City
Bern
ZIP/Postal Code
3012
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33648555
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.
Results Reference
derived

Learn more about this trial

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

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