We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01577290
First Posted: April 13, 2012
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Per Carlbring, PhD, Umeå University
  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
Intervention Model: Parallel Assignment
Masking: None (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 Per Carlbring, PhD, Umeå University:

Primary Outcome Measures:
  • Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 24 hours ]
    21 item rating scale for anxiety symptoms.

  • Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 6 months ]
    21 item rating scale for anxiety symptoms.


Secondary Outcome Measures:
  • Change from baseline in Beck Depression Inventory (BDI) [ Time Frame: 24 hours ]
    21 item rating scale for depression symptoms.

  • Change from baseline in Beck Depression Inventory (BDI) [ Time Frame: 6 months ]
    21 item rating scale for depression symptoms.

  • 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.

  • 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.

  • Change from baseline in Insomnia Severity Index (ISI) [ Time Frame: 24 hours ]
    7 item rating scale of insomnia symptoms.

  • Change from baseline in Insomnia Severity Index (ISI) [ Time Frame: 6 months ]
    7 item rating scale of insomnia symptoms.


Enrollment: 91
Study Start Date: March 2012
Study Completion Date: March 2014
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577290


Locations
Sweden
Department of Psychology, Umeå University
Umeå, Västerbotten, Sweden, 90181
Sponsors and Collaborators
Umeå University
Investigators
Principal Investigator: Per Carlbring, Professor Department of Psychology, Umeå University
  More Information

Publications:
Responsible Party: Per Carlbring, PhD, Professor, Umeå University
ClinicalTrials.gov Identifier: NCT01577290     History of Changes
Other Study ID Numbers: IMA
First Submitted: April 11, 2012
First Posted: April 13, 2012
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by Per Carlbring, PhD, Umeå University:
Anxiety
Depression
Insomnia
Mindfulness
Internet

Additional relevant MeSH terms:
Depression
Anxiety Disorders
Sleep Initiation and Maintenance Disorders
Behavioral Symptoms
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases