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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Per Carlbring, PhD, Umeå University
ClinicalTrials.gov Identifier:
NCT01570400
First received: March 29, 2012
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Social Phobia
Behavioral: Internet-administered cognitive behavioral therapy (iCBT)
Behavioral: Cognitive bias modification training program variant 1
Behavioral: Cognitive bias modification training program variant 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Reduction of Social Phobia Symptoms With Combined Internet-Based Cognitive Bias Modification and Cognitive Behavioral Therapy

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR) [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR) [ Time Frame: Two weeks into treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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: 11 weeks ] [ 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: 4 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 Quality Of Life Inventory (QOLI) [ Time Frame: 2 weeks into treatment ] [ 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 Social Phobia Scale + Social Interaction Anxiety Scale [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Self-rated measurements of social anxiety/phobia.

  • Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
    Self-rated measurements of social anxiety/phobia.

  • Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Self-rated measurements of social anxiety/phobia.

  • Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale [ Time Frame: 2 weeks into treatment ] [ Designated as safety issue: No ]
    Self-rated measurements of social anxiety/phobia.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 2 weeks into treatment ] [ Designated as safety issue: No ]
    9-item depression rating scale.

  • Change from baseline in mini-SPIN [ Time Frame: Daily, 1-15 days into treatment ] [ Designated as safety issue: No ]
    Mini-SPIN is a three-item self-rating scale for assessment of symptoms of social phobia using a five-point Likert scale.

  • Change from baseline in mini-SPIN [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
    Mini-SPIN is a three-item self-rating scale for assessment of symptoms of social phobia using a five-point Likert scale.

  • Change from baseline in mini-SPIN [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Mini-SPIN is a three-item self-rating scale for assessment of symptoms of social phobia using a five-point Likert scale.


Estimated Enrollment: 128
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570400

Locations
Sweden
Department of Psychology, Umeå University
Umeå, Västerbotten, Sweden, 90187
Sponsors and Collaborators
Umeå University
Investigators
Principal Investigator: Per Carlbring, Professor Department of Psychology, Umeå University
  More Information

No publications provided by Umeå University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Per Carlbring, PhD, Professor, Umeå University
ClinicalTrials.gov Identifier: NCT01570400     History of Changes
Other Study ID Numbers: SOFIE13a
Study First Received: March 29, 2012
Last Updated: January 15, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:
social phobia
social anxiety
cognitive bias modification

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014