Treatment of Social Phobia With Combined Cognitive Bias Modification and iCBT (SOFIE13a)

October 29, 2016 updated by: Per Carlbring, PhD, Umeå University

Reduction of Social Phobia Symptoms With Combined Internet-Based Cognitive Bias Modification and Cognitive Behavioral Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Västerbotten
      • Umeå, Västerbotten, Sweden, 90187
        • Department of Psychology, Umeå University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CBM training program variant 1 + iCBT
Cognitive bias modification training program variant 1 combined with iCBT
Behavioral: 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.
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.
EXPERIMENTAL: CBM training program variant 2 + iCBT
Cognitive bias modification training program variant 2 combined with iCBT
Behavioral: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
Time Frame: 24 hours
The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.
24 hours
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
Time Frame: 11 weeks
The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.
11 weeks
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
Time Frame: 4 months
The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.
4 months
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
Time Frame: Two weeks into treatment
The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.
Two weeks into treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: 24 hours
9-item depression rating scale.
24 hours
Change from baseline in Quality Of Life Inventory (QOLI)
Time Frame: 11 weeks
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.
11 weeks
Change from baseline in Quality Of Life Inventory (QOLI)
Time Frame: 4 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.
4 months
Change from baseline in Quality Of Life Inventory (QOLI)
Time Frame: 2 weeks into treatment
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.
2 weeks into treatment
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Time Frame: 24 hours
Self-rated measurements of social anxiety/phobia.
24 hours
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Time Frame: 11 weeks
Self-rated measurements of social anxiety/phobia.
11 weeks
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Time Frame: 4 months
Self-rated measurements of social anxiety/phobia.
4 months
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Time Frame: 2 weeks into treatment
Self-rated measurements of social anxiety/phobia.
2 weeks into treatment
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: 11 weeks
9-item depression rating scale.
11 weeks
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: 4 months
9-item depression rating scale.
4 months
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: 2 weeks into treatment
9-item depression rating scale.
2 weeks into treatment
Change from baseline in mini-SPIN
Time Frame: Daily, 1-15 days into treatment
Mini-SPIN is a three-item self-rating scale for assessment of symptoms of social phobia using a five-point Likert scale.
Daily, 1-15 days into treatment
Change from baseline in mini-SPIN
Time Frame: 11 weeks
Mini-SPIN is a three-item self-rating scale for assessment of symptoms of social phobia using a five-point Likert scale.
11 weeks
Change from baseline in mini-SPIN
Time Frame: 4 months
Mini-SPIN is a three-item self-rating scale for assessment of symptoms of social phobia using a five-point Likert scale.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

March 29, 2012

First Submitted That Met QC Criteria

April 3, 2012

First Posted (ESTIMATE)

April 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 29, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOFIE13a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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