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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02920320
Other study ID # TK001
Secondary ID
Status Completed
Phase N/A
First received September 27, 2016
Last updated October 16, 2017
Start date July 2016
Est. completion date September 2017

Study information

Verified date October 2017
Source University of Bern
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Internet-based self-help program


Locations

Country Name City State
Switzerland University of Bern Bern

Sponsors (1)

Lead Sponsor Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

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