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

Primary Purpose

Anxiety, Depression, Insomnia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-administered Mindfulness Training Program
Discussion group
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Depression, Insomnia, Mindfulness, Internet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Psychology, Umeå University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness training

Discussion group

Arm Description

Group receives mindfulness training.

Group has access to a discussion group.

Outcomes

Primary Outcome Measures

Change from baseline in Beck Anxiety Inventory (BAI)
21 item rating scale for anxiety symptoms.
Change from baseline in Beck Anxiety Inventory (BAI)
21 item rating scale for anxiety symptoms.

Secondary Outcome Measures

Change from baseline in Beck Depression Inventory (BDI)
21 item rating scale for depression symptoms.
Change from baseline in Beck Depression Inventory (BDI)
21 item rating scale for depression symptoms.
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.
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.
Change from baseline in Insomnia Severity Index (ISI)
7 item rating scale of insomnia symptoms.
Change from baseline in Insomnia Severity Index (ISI)
7 item rating scale of insomnia symptoms.

Full Information

First Posted
April 11, 2012
Last Updated
October 29, 2016
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT01577290
Brief Title
An Internet-administered, Mindfulness Training Program for the Treatment of Anxiety
Official Title
An Internet-administered, Mindfulness Training Program for the Treatment of Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Insomnia
Keywords
Anxiety, Depression, Insomnia, Mindfulness, Internet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness training
Arm Type
Experimental
Arm Description
Group receives mindfulness training.
Arm Title
Discussion group
Arm Type
Active Comparator
Arm Description
Group has access to a discussion group.
Intervention Type
Behavioral
Intervention Name(s)
Internet-administered Mindfulness Training Program
Intervention Description
A 10 week, internet-administered mindfulness training program, featuring no therapist-support. 10 minutes of training, twice per day.
Intervention Type
Behavioral
Intervention Name(s)
Discussion group
Intervention Description
Access to a discussion group with the possibility of sharing experiences, methods of relief, and the like.
Primary Outcome Measure Information:
Title
Change from baseline in Beck Anxiety Inventory (BAI)
Description
21 item rating scale for anxiety symptoms.
Time Frame
24 hours
Title
Change from baseline in Beck Anxiety Inventory (BAI)
Description
21 item rating scale for anxiety symptoms.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline in Beck Depression Inventory (BDI)
Description
21 item rating scale for depression symptoms.
Time Frame
24 hours
Title
Change from baseline in Beck Depression Inventory (BDI)
Description
21 item rating scale for depression symptoms.
Time Frame
6 months
Title
Change from baseline in Quality Of Life Inventory (QOLI)
Description
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.
Time Frame
24 hours
Title
Change from baseline in Quality Of Life Inventory (QOLI)
Description
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.
Time Frame
6 months
Title
Change from baseline in Insomnia Severity Index (ISI)
Description
7 item rating scale of insomnia symptoms.
Time Frame
24 hours
Title
Change from baseline in Insomnia Severity Index (ISI)
Description
7 item rating scale of insomnia symptoms.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Carlbring, Professor
Organizational Affiliation
Department of Psychology, Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychology, Umeå University
City
Umeå
State/Province
Västerbotten
ZIP/Postal Code
90181
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24491199
Citation
Boettcher J, Astrom V, Pahlsson D, Schenstrom 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.
Results Reference
result

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

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