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

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ClinicalTrials.gov Identifier: NCT01570400
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Reduction of Social Phobia Symptoms With Combined Internet-Based Cognitive Bias Modification and Cognitive Behavioral Therapy
Study Start Date : September 2012
Primary Completion Date : September 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Phobias
U.S. FDA Resources

Arms and Interventions

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.



Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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. 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.

  5. Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale [ Time Frame: 24 hours ]
    Self-rated measurements of social anxiety/phobia.

  6. Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale [ Time Frame: 11 weeks ]
    Self-rated measurements of social anxiety/phobia.

  7. Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale [ Time Frame: 4 months ]
    Self-rated measurements of social anxiety/phobia.

  8. Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale [ Time Frame: 2 weeks into treatment ]
    Self-rated measurements of social anxiety/phobia.

  9. Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours ]
    9-item depression rating scale.

  10. Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 11 weeks ]
    9-item depression rating scale.

  11. Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 4 months ]
    9-item depression rating scale.

  12. Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 2 weeks into treatment ]
    9-item depression rating scale.

  13. 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.

  14. 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.

  15. 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.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Per Carlbring, PhD, Professor, Umeå University
ClinicalTrials.gov Identifier: NCT01570400     History of Changes
Other Study ID Numbers: SOFIE13a
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by Per Carlbring, PhD, Umeå University:
social phobia
social anxiety
cognitive bias modification

Additional relevant MeSH terms:
Phobic Disorders
Phobia, Social
Anxiety Disorders
Mental Disorders