NCT01570374

Brief Summary

The purpose of this study is to determine whether internet-administered cognitive behavior therapy is a feasible treatment for generalized anxiety disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

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

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 4, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

4 years

First QC Date

March 31, 2012

Last Update Submit

October 31, 2016

Conditions

Generalized Anxiety Disorder

Keywords

Cognitive behavioral therapyInternetAnxietyGeneralized anxiety disorder

Outcome Measures

Primary Outcomes (4)

  • Change from baseline in Penn State Worry Questionnaire (PSWQ)

    Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.

    24 hours

  • Change from baseline in Penn State Worry Questionnaire (PSWQ)

    Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.

    6 months

  • Change from baseline in Penn State Worry Questionnaire (PSWQ)

    Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.

    12 months

  • Change from baseline in Penn State Worry Questionnaire (PSWQ)

    Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.

    24 months

Secondary Outcomes (22)

  • Change from baseline in Beck Anxiety Inventory (BAI)

    24 hours

  • Change from baseline in Beck Anxiety Inventory (BAI)

    6 months

  • Change from baseline in Beck Anxiety Inventory (BAI)

    12 months

  • Change from baseline in Beck Anxiety Inventory (BAI)

    24 months

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

    24 hours

  • +17 more secondary outcomes

Study Arms (2)

iCBT

EXPERIMENTAL

Receives treatment.

Behavioral: Internet-based cognitive behavioral therapy (iCBT)

Waiting list control group

NO INTERVENTION

The waiting list control group initially receives no treatment, but do weekly screenings. After 9 weeks, the control group receives the same treatment as the other study arm.

Interventions

Internet-based cognitive behavioral therapy (iCBT)BEHAVIORAL

9 week internet-administered, therapist-assisted, controlled-progression cognitive behavioral therapy (iCBT). Individualized and disorder-specific.

iCBT

Eligibility Criteria

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

You may qualify if:

  • Satisfy DSM-IV criteria for generalized 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)

  • Dahlin M, Andersson G, Magnusson K, Johansson T, Sjogren J, Hakansson A, Pettersson M, Kadowaki A, Cuijpers P, Carlbring P. Internet-delivered acceptance-based behaviour therapy for generalized anxiety disorder: A randomized controlled trial. Behav Res Ther. 2016 Feb;77:86-95. doi: 10.1016/j.brat.2015.12.007. Epub 2015 Dec 21.

    PMID: 26731173RESULT

MeSH Terms

Conditions

Generalized Anxiety DisorderAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

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

March 31, 2012

First Posted

April 4, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

SE(1)