Treatment of Social Phobia With Combined Cognitive Bias Modification and iCBT

NCT ID: NCT01570400

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether an internet-based treatment program, consisting of combined cognitive bias modification and cognitive behavioral therapy, reduces symptoms of social phobia among a population diagnosed with this disorder.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Previous studies have shown that individuals with social phobia have attention biases, often focusing on or avoiding aversive stimuli (such as judging facial expressions) and thereby reinforcing the bias. Computerized training programs have been developed to implicitly direct the users attention. In this study, such a program -- combined with an established, well-researched and proven effective form of internet-based cognitive behavioral therapy (iCBT) -- will be provided to 128 participants that meet the diagnostic criteria for social phobia, and the pre/post-measurements will be compared. Participants will be randomized to one of two groups, receiving one of two variants of the cognitive bias modification program (both receive iCBT).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Social Phobia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

social phobia social anxiety cognitive bias modification

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CBM training program variant 1 + iCBT

Cognitive bias modification training program variant 1 combined with iCBT

Group Type EXPERIMENTAL

Internet-administered cognitive behavioral therapy (iCBT)

Intervention Type BEHAVIORAL

Established form of internet-administered cognitive behavioral therapy. Controlled progress, self-help modules with psychoeducative texts, assignments and homework. Therapist assisted.

Cognitive bias modification training program variant 1

Intervention Type BEHAVIORAL

Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 4. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (\< or \>) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more negative word or face.

Duration: approx. 10 min. per session. Frequency: Once every day for 2 weeks.

CBM training program variant 2 + iCBT

Cognitive bias modification training program variant 2 combined with iCBT

Group Type EXPERIMENTAL

Internet-administered cognitive behavioral therapy (iCBT)

Intervention Type BEHAVIORAL

Established form of internet-administered cognitive behavioral therapy. Controlled progress, self-help modules with psychoeducative texts, assignments and homework. Therapist assisted.

Cognitive bias modification training program variant 2

Intervention Type BEHAVIORAL

Computerized, internet-based control training program, variant 2. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (\< or \>) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe follows the more positive stimulus and the more negative stimulus with equal frequency.

Duration: approx. 10 min. per session. Frequency: Once every day for 2 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Internet-administered cognitive behavioral therapy (iCBT)

Established form of internet-administered cognitive behavioral therapy. Controlled progress, self-help modules with psychoeducative texts, assignments and homework. Therapist assisted.

Intervention Type BEHAVIORAL

Cognitive bias modification training program variant 1

Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 4. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (\< or \>) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more negative word or face.

Duration: approx. 10 min. per session. Frequency: Once every day for 2 weeks.

Intervention Type BEHAVIORAL

Cognitive bias modification training program variant 2

Computerized, internet-based control training program, variant 2. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (\< or \>) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe follows the more positive stimulus and the more negative stimulus with equal frequency.

Duration: approx. 10 min. per session. Frequency: Once every day for 2 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Written informed consent provided
* Diagnosed social phobia (according to DSM-IV criteria)
* Access to computer with internet connection

Exclusion Criteria

* Severe depression (and/or suicidal behavior)
* Suffer from other severe psychiatric condition (e.g. psychosis)
* Non-stable use of medication (3 months stable dosage)
* Undergoing other, parallel psychological treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Umeå University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Per Carlbring, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Per Carlbring, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Psychology, Umeå University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Psychology, Umeå University

Umeå, Västerbotten County, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Boettcher J, Andersson G, Carlbring P; SOFIE-13 Research Group. Combining attention training with cognitive-behavior therapy in Internet-based self-help for social anxiety: study protocol for a randomized controlled trial. Trials. 2013 Mar 8;14:68. doi: 10.1186/1745-6215-14-68.

Reference Type BACKGROUND
PMID: 23497513 (View on PubMed)

Boettcher J, Hasselrot J, Sund E, Andersson G, Carlbring P. Combining attention training with internet-based cognitive-behavioural self-help for social anxiety: a randomised controlled trial. Cogn Behav Ther. 2014;43(1):34-48. doi: 10.1080/16506073.2013.809141. Epub 2013 Jul 30.

Reference Type RESULT
PMID: 23898817 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SOFIE13a

Identifier Type: -

Identifier Source: org_study_id