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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Umeå University.
Recruitment status was  Recruiting
Sponsor:
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
  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 April 17, 2014