iCompassion: Internet-based Self-help for More Self-compassion (iCompassion)

October 16, 2017 updated by: University of Bern
In this study, people who suffer from strong self-critical tendencies will be randomized to two study conditions. The first group receives an account to an internet-based self-help intervention. The second group is a waiting control group. In both conditions additional care or treatment is allowed. The aim of the study is to investigate the effectiveness of an internet-based self-help intervention on depressive, anxiety and stress symptoms compared to a waiting list. Assessments are at baseline, 8-week and 6-months post-randomization. After 8 weeks, participants in the waiting control group get also access to the intervention and fill out questionnaires after 8 weeks again.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3012
        • University of Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Increased levels of self-criticism
  • 18 years or older
  • Internet account
  • Sufficient German language skills
  • Written informed consent

Exclusion Criteria:

  • Substance dependence, psychotic disorder, bipolar disorder
  • Acute suicidality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet-based self-help
Internet-based self-help on the basis of the program "Mindfulness-Based Compassionate Living" (van den Brink & Koster, 2015). The self-help program consists of seven text-based sessions, various exercises (z.B. breathing meditations, diaries,) and tasks. Participants have the possibility for guidance to the program on request.
Other: Internet-based self-help program
No Intervention: Waiting control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depression anxiety stress scale (DASS)
Time Frame: 8-week
8-week

Secondary Outcome Measures

Outcome Measure
Time Frame
Self-Compassion Scale
Time Frame: Baseline, 8-week, 6-month
Baseline, 8-week, 6-month
Mini International Neuropsychiatric Interview
Time Frame: Baseline, 8-week
Baseline, 8-week
Forms of Self-Criticism and Self-Reassurance Scale
Time Frame: Baseline, 8-week, 6-month
Baseline, 8-week, 6-month
Comprehensive Inventory of Mindfulness Experiences
Time Frame: Baseline, 8-week, 6-month
Baseline, 8-week, 6-month
Positive and Negative Affective Schedule
Time Frame: Baseline, 8-week, 6-month
Baseline, 8-week, 6-month
Fear of Self-Compassion Scale
Time Frame: Baseline, 8-week, 6-month
Baseline, 8-week, 6-month
Satisfaction with Life Scale
Time Frame: Baseline, 8-week, 6-month
Baseline, 8-week, 6-month
Questionnaire for the Assessment of Adaptive and Maladaptive Shame
Time Frame: Baseline, 8-week, 6-month
Baseline, 8-week, 6-month
Rosenberg Self-Esteem Scale
Time Frame: Baseline, 8-week, 6-month follow-up
Baseline, 8-week, 6-month follow-up
Client Satisfaction Questionnaire
Time Frame: 8-week
8-week
Depression anxiety stress scale (DASS)
Time Frame: 6-month
6-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bern

Investigators

  • Principal Investigator: Tobias Krieger, PhD, University of Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

September 28, 2016

First Posted (Estimate)

September 30, 2016

Study Record Updates

Last Update Posted (Actual)

October 18, 2017

Last Update Submitted That Met QC Criteria

October 16, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • TK001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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