NCT01577290

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

April 11, 2012

Last Update Submit

October 29, 2016

Conditions

AnxietyDepressionInsomnia

Keywords

AnxietyDepressionInsomniaMindfulnessInternet

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in Beck Anxiety Inventory (BAI)

    21 item rating scale for anxiety symptoms.

    24 hours

  • Change from baseline in Beck Anxiety Inventory (BAI)

    21 item rating scale for anxiety symptoms.

    6 months

Secondary Outcomes (6)

  • Change from baseline in Beck Depression Inventory (BDI)

    24 hours

  • Change from baseline in Beck Depression Inventory (BDI)

    6 months

  • Change from baseline in Quality Of Life Inventory (QOLI)

    24 hours

  • Change from baseline in Quality Of Life Inventory (QOLI)

    6 months

  • Change from baseline in Insomnia Severity Index (ISI)

    24 hours

  • +1 more secondary outcomes

Study Arms (2)

Mindfulness training

EXPERIMENTAL

Group receives mindfulness training.

Behavioral: Internet-administered Mindfulness Training Program

Discussion group

ACTIVE COMPARATOR

Group has access to a discussion group.

Behavioral: Discussion group

Interventions

Internet-administered Mindfulness Training ProgramBEHAVIORAL

A 10 week, internet-administered mindfulness training program, featuring no therapist-support. 10 minutes of training, twice per day.

Mindfulness training
Discussion groupBEHAVIORAL

Access to a discussion group with the possibility of sharing experiences, methods of relief, and the like.

Discussion group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Satisfy DSM-IV criteria for an anxiety disorder
  • Living in Sweden and being able to read Swedish
  • Access to computer with internet connection

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, Umeå University

Umeå, Västerbotten County, 90181, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 24491199RESULT

MeSH Terms

Conditions

Anxiety DisordersDepressionSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Per Carlbring, Professor

    Department of Psychology, Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 11, 2012

First Posted

April 13, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2013

Study Completion

March 1, 2014

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

SE(1)