An Internet-administered, Mindfulness Training Program for the Treatment of Anxiety

October 29, 2016 updated by: Per Carlbring, PhD, Umeå University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

91

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

  • Sweden
    • Västerbotten
      • Umeå, Västerbotten, Sweden, 90181
        • Department of Psychology, Umeå University

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:

  • 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 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Beck Anxiety Inventory (BAI)
Time Frame: 24 hours
21 item rating scale for anxiety symptoms.
24 hours
Change from baseline in Beck Anxiety Inventory (BAI)
Time Frame: 6 months
21 item rating scale for anxiety symptoms.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Quality Of Life Inventory (QOLI)
Time Frame: 24 hours
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
Change from baseline in Quality Of Life Inventory (QOLI)
Time Frame: 6 months
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
Change from baseline in Beck Depression Inventory (BDI)
Time Frame: 24 hours
21 item rating scale for depression symptoms.
24 hours
Change from baseline in Beck Depression Inventory (BDI)
Time Frame: 6 months
21 item rating scale for depression symptoms.
6 months
Change from baseline in Insomnia Severity Index (ISI)
Time Frame: 24 hours
7 item rating scale of insomnia symptoms.
24 hours
Change from baseline in Insomnia Severity Index (ISI)
Time Frame: 6 months
7 item rating scale of insomnia symptoms.
6 months

Collaborators and Investigators

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

Sponsor

Umeå University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

April 11, 2012

First Submitted That Met QC Criteria

April 11, 2012

First Posted (Estimate)

April 13, 2012

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 29, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMA

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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