An Internet-administered, Mindfulness Training Program for the Treatment of Anxiety
This study is currently recruiting participants.
Verified April 2012 by Umeå University
Sponsor:
Umeå University
Information provided by (Responsible Party):
Per Carlbring, PhD, Umeå University
ClinicalTrials.gov Identifier:
NCT01577290
First received: April 11, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Anxiety Depression Insomnia |
Behavioral: Internet-administered Mindfulness Training Program Behavioral: Discussion group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Internet-administered, Mindfulness Training Program for the Treatment of Anxiety |
Resource links provided by NLM:
Further study details as provided by Umeå University:
Primary Outcome Measures:
- Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]21 item rating scale for anxiety symptoms.
- Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]21 item rating scale for anxiety symptoms.
Secondary Outcome Measures:
- Change from baseline in Beck Depression Inventory (BDI) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]21 item rating scale for depression symptoms.
- Change from baseline in Beck Depression Inventory (BDI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]21 item rating scale for depression symptoms.
- Change from baseline in Quality Of Life Inventory (QOLI) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]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.
- Change from baseline in Quality Of Life Inventory (QOLI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- Change from baseline in Insomnia Severity Index (ISI) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]7 item rating scale of insomnia symptoms.
- Change from baseline in Insomnia Severity Index (ISI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]7 item rating scale of insomnia symptoms.
| Estimated Enrollment: | 128 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Mindfulness training
Group receives mindfulness training.
|
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.
|
|
Active Comparator: Discussion group
Group has access to a discussion group.
|
Behavioral: Discussion group
Access to a discussion group with the possibility of sharing experiences, methods of relief, and the like.
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577290
Locations
| Sweden | |
| Department of Psychology, Umeå University | Recruiting |
| Umeå, Västerbotten, Sweden, 90181 | |
| Contact: Per Carlbring, Professor +46 90-786 78 33 per.carlbring@psy.umu.se | |
| Principal Investigator: Per Carlbring, Professor | |
Sponsors and Collaborators
Umeå University
Investigators
| Principal Investigator: | Per Carlbring, Professor | Department of Psychology, Umeå University |
More Information
No publications provided
| Responsible Party: | Per Carlbring, PhD, Professor, Umeå University |
| ClinicalTrials.gov Identifier: | NCT01577290 History of Changes |
| Other Study ID Numbers: | IMA |
| Study First Received: | April 11, 2012 |
| Last Updated: | April 11, 2012 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Umeå University:
|
Anxiety Depression Insomnia Mindfulness Internet |
Additional relevant MeSH terms:
|
Anxiety Disorders Depression Depressive Disorder Sleep Initiation and Maintenance Disorders Mental Disorders Behavioral Symptoms |
Mood Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013