NCT04380909: ROCO

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

Completed NA Last updated 24 August 2021

What this trial tests

NA trial testing Internet-based self-help in Psychological Distress in 107 participants. Completed in 29 July 2021.

Timeline

6 May 2020

Primary endpoint
29 July 2021

29 July 2021

Quick facts

Lead sponsor	University of Bern
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	107
Start date	6 May 2020
Primary completion	29 July 2021
Estimated completion	29 July 2021
Sites	1 location across Switzerland

Drugs / interventions tested

• Internet-based self-help
• Internet-based self-help after 3 weeks

Conditions studied

• Psychological Distress — all drugs for Psychological Distress →
• Adjustment, Psychological — all drugs for Adjustment, Psychological →
• Coronavirus — all drugs for Coronavirus →

Sponsor

University of Bern

Who can join

18 and older, any sex, with Psychological Distress or Adjustment, Psychological. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of an internet-based self-help intervention for psychological distress due to COVID-19: Results of a randomized controlled trial.
   Brog NA, Hegy JK, Berger T, Znoj H. · · 2022 · cited 28× · PMID 34956841 · DOI 10.1016/j.invent.2021.100492
2. An internet-based self-help intervention for people with psychological distress due to COVID-19: study protocol for a randomized controlled trial.
   Brog NA, Hegy JK, Berger T, Znoj H. · · 2021 · cited 10× · PMID 33648555 · DOI 10.1186/s13063-021-05089-9
3. Long-term improvement of psoriasis patients' adherence to topical drugs: testing a patient-supporting intervention delivered by healthcare professionals.
   Svendsen MT, Feldman SR, Möller S, Kongstad LP, et al · · 2021 · cited 8× · PMID 34696820 · DOI 10.1186/s13063-021-05707-6
4. Age, Motivation, and Emotion Regulation Skills Predict Treatment Outcome in an Internet-Based Self-Help Intervention for COVID-19 Related Psychological Distress.
   Brog NA, Hegy JK, Berger T, Znoj H. · · 2022 · cited 2× · PMID 35757638 · DOI 10.3389/fpubh.2022.835356
5. An internet-based self-help intervention for people with psychological distress due to COVID-19: study protocol for a randomized controlled trial.
   Brog NA, Hegy J, Berger T, Znoj H. · · 2021 · DOI 10.21203/rs.3.rs-59343/v2