ROCO - Self-help for People With Psychological Distress Due to the Covid-19 Situation
NCT ID: NCT04380909
Last Updated: 2021-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
107 participants
INTERVENTIONAL
2020-05-06
2021-07-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Internet-based Self-help Treatment for Panic Disorder: Two Ways of Complementary Psychological Support
NCT02402322
A Online-delivered Cognitive-behavioral Intervention for Dysfunctional Worry Related to the Covid-19 Pandemic
NCT04341922
Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders
NCT01953042
Copeptin During a Standardized Psychological Stress Test
NCT01866137
Project H-COVID: Evaluating Hyper-Brief, Online Materials During the COVID-19 Pandemic
NCT04459455
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Waiting control group
Access to internet-based intervention after 3 weeks.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Existence of a known diagnosis of a psychotic or bipolar disorder
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Bern
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hansjörg Znoj, Prof. Dr.
Role: STUDY_DIRECTOR
University of Bern
Thomas Berger, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Bern
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universität Bern
Bern, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-00990
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.