Self-criticismiCompassionNCT02920320
iCompassion: Internet-based Self-help for More Self-compassion
A study testing Internet-based self-help program in people with Self-criticism, run by University of Bern at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Self-criticism
- What is being tested?
- Internet-based self-help program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2016to Sep 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Increased levels of self-criticism
- 18 years or older
- Internet account
- Sufficient German language skills
- Written informed consent
Who cannot join
- Substance dependence, psychotic disorder, bipolar disorder
- Acute suicidality
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Self-criticism
- Being tested
- Internet-based self-help program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based self-help programOther
| Study group | Role | What they receive |
|---|---|---|
| Internet-based self-help | Experimental | 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. Receives: Other: Internet-based self-help program |
| Waiting control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression anxiety stress scale (DASS)
Measured: 8-week
Secondary outcomes (11)
Self-Compassion Scale
Measured: Baseline, 8-week, 6-month
Mini International Neuropsychiatric Interview
Measured: Baseline, 8-week
Forms of Self-Criticism and Self-Reassurance Scale
Measured: Baseline, 8-week, 6-month
Comprehensive Inventory of Mindfulness Experiences
Measured: Baseline, 8-week, 6-month
Positive and Negative Affective Schedule
Measured: Baseline, 8-week, 6-month
Fear of Self-Compassion Scale
Measured: Baseline, 8-week, 6-month
Satisfaction with Life Scale
Measured: Baseline, 8-week, 6-month
Questionnaire for the Assessment of Adaptive and Maladaptive Shame
Measured: Baseline, 8-week, 6-month
Rosenberg Self-Esteem Scale
Measured: Baseline, 8-week, 6-month follow-up
Client Satisfaction Questionnaire
Measured: 8-week
Depression anxiety stress scale (DASS)
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-criticismStudies of the same condition, open and under way.
- 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
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Krieger, PhD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920320
- Sponsor's protocol ID
- TK001
- Acronym
- iCompassion
- Status last verified
- Oct 2017
- First submitted
- 27 Sep 2016
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iCompassion: Internet-based Self-help for More Self-compassion
- ClinicalTrials.gov ID
- NCT02920320
- Acronym / sponsor ID
- iCompassion / TK001
- Conditions
- Self-criticism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 30 Sep 2016 (estimated)
- 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.
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 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 | Other: Internet-based self-help programInternet-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. |
| Waiting control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Increased levels of self-criticism
- 18 years or older
- Internet account
- Sufficient German language skills
- Written informed consent
Key exclusion criteria (2 listed)
- Substance dependence, psychotic disorder, bipolar disorder
- Acute suicidality
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-help program | Other | Internet-based self-help |
Primary outcome
Depression anxiety stress scale (DASS)
Time frame: 8-week
11 secondary outcomes
Self-Compassion Scale
Time frame: Baseline, 8-week, 6-month
Mini International Neuropsychiatric Interview
Time frame: Baseline, 8-week
Forms of Self-Criticism and Self-Reassurance Scale
Time frame: Baseline, 8-week, 6-month
Comprehensive Inventory of Mindfulness Experiences
Time frame: Baseline, 8-week, 6-month
Positive and Negative Affective Schedule
Time frame: Baseline, 8-week, 6-month
Fear of Self-Compassion Scale
Time frame: Baseline, 8-week, 6-month
Satisfaction with Life Scale
Time frame: Baseline, 8-week, 6-month
Questionnaire for the Assessment of Adaptive and Maladaptive Shame
Time frame: Baseline, 8-week, 6-month
Rosenberg Self-Esteem Scale
Time frame: Baseline, 8-week, 6-month follow-up
Client Satisfaction Questionnaire
Time frame: 8-week
Depression anxiety stress scale (DASS)
Time frame: 6-month
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 18 Oct 2017.
- Individual participant dataSharing planned: Undecided
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Brief Interventions for Coping with Distress
Distress, Emotional, Emotional Dysfunction
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.
Tobias Krieger, PhD 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 program in people with Self-criticism, 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 5 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 18 Oct 2017. 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?
Depression anxiety stress scale (DASS) (time frame: 8-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2017.