Psychological DistressROCONCT04380909
ROCO - Self-help for People With Psychological Distress Due to the Covid-19 Situation
A study testing Internet-based self-help and Internet-based self-help after 3 weeks in people with Psychological Distress and Adjustment, Psychological, run by University of Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Distress, Adjustment, Psychological, Coronavirus
- What is being tested?
- Internet-based self-help and Internet-based self-help after 3 weeks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 May 2020to 29 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Suicidal tendencies (SBQ-R Score ≥ 8)
- Existence of a known diagnosis of a psychotic or bipolar disorder
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Internet-based self-help, Internet-based self-help after 3 weeks
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based self-helpBehavioural
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 weeksBehavioural
Six cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of psychological distress due to the Covid-19 situation.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based self-help | Experimental | 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. Receives: Behavioral: Internet-based self-help |
| Waiting control group | Other | Access to internet-based intervention after 3 weeks. Receives: Behavioral: Internet-based self-help after 3 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (Löwe et al., 2002)
9-item questionnaire assessing depressive symptoms
Measured: up to 18 weeks
Secondary outcomes (11)
Suicide Behavior Questionnaire Revised (Glaesmer et al., 2018)
4-item questionnaire assessing suicidal ideation
Measured: up to 18 weeks
DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)
21-item questionnaire assessing depression, anxiety and stress symptoms
Measured: up to 18 weeks
SF-12: Short Form Health Survey (Ware et al., 1996)
12-item questionnaire assessing various aspects of well-being
Measured: up to 18 weeks
LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)
10-item questionnaire assessing optimism and pessimism
Measured: up to 18 weeks
Berner Verbitterungsinventar Kurzversion (Znoj, 2008)
6-item questionnaire assessing embitterment
Measured: up to 18 weeks
Emotion regulation skills SEK-27 (Berking & Znoj, 2008)
27-item questionnaire assessing emotion regulation skills
Measured: up to 18 weeks
SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)
10-item questionnaire assessing general self-efficacy
Measured: up to 18 weeks
UCLA Loneliness Scale (Döring & Bortz, 1993)
9-item questionnaire assessing loneliness
Measured: up to 18 weeks
Connor-Davidson Resilience Scale (Sarubin et al., 2015)
10-item questionnaire assessing resilience
Measured: up to 18 weeks
ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)
8-item questionnaire assessing content with an online-program
Measured: at 3 weeks for experimental group and at 6 weeks for waiting control group
SUS: System Usability Scale (Brooke, 1996)
10-item questionnaire assessing usability of an online-program
Measured: at 3 weeks for experimental group and at 6 weeks for waiting control group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start6 May 2020
- Primary completion29 Jul 2021
- Study completion29 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hansjörg Znoj, Prof. Dr., Study director, University of BernThomas Berger, Prof. Dr., Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380909
- Sponsor's protocol ID
- 2020-00990
- Acronym
- ROCO
- Status last verified
- Aug 2021
- First submitted
- 7 May 2020
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33648555
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04380909
- Acronym / sponsor ID
- ROCO / 2020-00990
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 6 May 2020 (actual)
- Primary completion
- 29 Jul 2021 (actual)
- Study completion
- 29 Jul 2021 (actual)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based self-help | Experimental | Behavioral: Internet-based self-helpThe 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. |
| Waiting control group | Other | Behavioral: Internet-based self-help after 3 weeksAccess to internet-based intervention after 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- Suicidal tendencies (SBQ-R Score ≥ 8)
- Existence of a known diagnosis of a psychotic or bipolar disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based self-helpSix cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of psychological distress due to the Covid-19 situation. | Behavioural | Internet-based self-help |
| Internet-based self-help after 3 weeksSix cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of psychological distress due to the Covid-19 situation. | Behavioural | Waiting control group |
Primary outcome
Patient Health Questionnaire (Löwe et al., 2002)
Time frame: up to 18 weeks
9-item questionnaire assessing depressive symptoms
11 secondary outcomes
Suicide Behavior Questionnaire Revised (Glaesmer et al., 2018)
Time frame: up to 18 weeks
DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)
Time frame: up to 18 weeks
SF-12: Short Form Health Survey (Ware et al., 1996)
Time frame: up to 18 weeks
LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)
Time frame: up to 18 weeks
Berner Verbitterungsinventar Kurzversion (Znoj, 2008)
Time frame: up to 18 weeks
Emotion regulation skills SEK-27 (Berking & Znoj, 2008)
Time frame: up to 18 weeks
SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)
Time frame: up to 18 weeks
UCLA Loneliness Scale (Döring & Bortz, 1993)
Time frame: up to 18 weeks
Connor-Davidson Resilience Scale (Sarubin et al., 2015)
Time frame: up to 18 weeks
ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)
Time frame: at 3 weeks for experimental group and at 6 weeks for waiting control group
SUS: System Usability Scale (Brooke, 1996)
Time frame: at 3 weeks for experimental group and at 6 weeks for waiting control group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Derived from this study: PubMed 33648555Brog 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.
- Individual participant dataSharing planned: No
Related trials for Psychological Distress
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Recruiting
Effects of a Mindful Self-Compassion Intervention on Psychological Adjustment in Breast Cancer Survivors
Breast Cancer
Not yet recruiting
Group Psychological Intervention to Reduce Distress Among Nursing Undergraduates
Psychological Distress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hansjörg Znoj, Prof. Dr. study director
University of Bern
Thomas Berger, Prof. Dr. principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based self-help and Internet-based self-help after 3 weeks in people with Psychological Distress and Adjustment, Psychological, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (Löwe et al., 2002) (time frame: up to 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04380909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.