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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01577290
Other study ID # IMA
Secondary ID
Status Completed
Phase N/A
First received April 11, 2012
Last updated October 29, 2016
Start date March 2012
Est. completion date March 2014

Study information

Verified date October 2016
Source Umeå University
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the effects of a 10 week mindfulness training program -- without therapist-support -- as treatment of anxiety. Effects on depression, quality of life, and insomnia symptoms will also be studied.


Description:

Previous research has provided evidence for the thesis that training in mindfulness can decrease symptoms of anxiety and depression. This study will examine the effects of a 10 week mindfulness training program -- without therapist-support -- as treatment of anxiety. Effects on depression, quality of life, and insomnia symptoms will also be studied.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date March 2014
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Satisfy DSM-IV criteria for an anxiety disorder

- Living in Sweden and being able to read Swedish

- Access to computer with internet connection

Exclusion Criteria:

- Currently receiving other psychological treatment

- Non-stable use of psychoactive medication

- Deemed suicidal

- Deemed to suffer from other psychological disorder, e.g. psychosis, bipolarity etc.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Internet-administered Mindfulness Training Program
A 10 week, internet-administered mindfulness training program, featuring no therapist-support. 10 minutes of training, twice per day.
Discussion group
Access to a discussion group with the possibility of sharing experiences, methods of relief, and the like.

Locations

Country Name City State
Sweden Department of Psychology, Umeå University Umeå Västerbotten

Sponsors (1)

Lead Sponsor Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Boettcher J, Aström V, Påhlsson D, Schenström O, Andersson G, Carlbring P. Internet-based mindfulness treatment for anxiety disorders: a randomized controlled trial. Behav Ther. 2014 Mar;45(2):241-53. doi: 10.1016/j.beth.2013.11.003. Epub 2013 Nov 25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in Beck Anxiety Inventory (BAI) 21 item rating scale for anxiety symptoms. 24 hours No
Primary Change from baseline in Beck Anxiety Inventory (BAI) 21 item rating scale for anxiety symptoms. 6 months No
Secondary Change from baseline in Beck Depression Inventory (BDI) 21 item rating scale for depression symptoms. 24 hours No
Secondary Change from baseline in Beck Depression Inventory (BDI) 21 item rating scale for depression symptoms. 6 months No
Secondary Change from baseline in Quality Of Life Inventory (QOLI) The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health. 24 hours No
Secondary Change from baseline in Quality Of Life Inventory (QOLI) The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health. 6 months No
Secondary Change from baseline in Insomnia Severity Index (ISI) 7 item rating scale of insomnia symptoms. 24 hours No
Secondary Change from baseline in Insomnia Severity Index (ISI) 7 item rating scale of insomnia symptoms. 6 months No
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