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Completed

NCT Number: NCT04380909

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

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.

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Key information

Conditions

Psychological Distress Adjustment, Psychological Coronaviridae Infections Coronavirus Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universität Bern

Bern, 3012, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-based self-help

Behavioral

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

Behavioral

Six cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of psychological distress due to the Covid-19 situation.

Primary outcomes

  1. Patient Health Questionnaire (Löwe et al., 2002)

    Time frame: up to 18 weeks

    9-item questionnaire assessing depressive symptoms

Secondary outcomes

  1. Suicide Behavior Questionnaire Revised (Glaesmer et al., 2018)

    Time frame: up to 18 weeks

    4-item questionnaire assessing suicidal ideation

  2. DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)

    Time frame: up to 18 weeks

    21-item questionnaire assessing depression, anxiety and stress symptoms

  3. SF-12: Short Form Health Survey (Ware et al., 1996)

    Time frame: up to 18 weeks

    12-item questionnaire assessing various aspects of well-being

  4. LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)

    Time frame: up to 18 weeks

    10-item questionnaire assessing optimism and pessimism

  5. Berner Verbitterungsinventar Kurzversion (Znoj, 2008)

    Time frame: up to 18 weeks

    6-item questionnaire assessing embitterment

  6. Emotion regulation skills SEK-27 (Berking & Znoj, 2008)

    Time frame: up to 18 weeks

    27-item questionnaire assessing emotion regulation skills

  7. SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)

    Time frame: up to 18 weeks

    10-item questionnaire assessing general self-efficacy

  8. UCLA Loneliness Scale (Döring & Bortz, 1993)

    Time frame: up to 18 weeks

    9-item questionnaire assessing loneliness

  9. Connor-Davidson Resilience Scale (Sarubin et al., 2015)

    Time frame: up to 18 weeks

    10-item questionnaire assessing resilience

  10. ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)

    Time frame: at 3 weeks for experimental group and at 6 weeks for waiting control group

    8-item questionnaire assessing content with an online-program

  11. SUS: System Usability Scale (Brooke, 1996)

    Time frame: at 3 weeks for experimental group and at 6 weeks for waiting control group

    10-item questionnaire assessing usability of an online-program

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study 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

Acronym: ROCO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 8, 2020
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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