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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

March 29, 2012
January 15, 2013
September 2012
September 2014   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01570400 on ClinicalTrials.gov Archive Site
  • 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.
  • 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: 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: 12 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: 24 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 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: 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: 12 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: 24 months ] [ 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: 4 months ] [ Designated as safety issue: No ]
    9-item depression rating scale.
  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    9-item depression rating scale.
  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    9-item depression rating scale.
Not Provided
Not Provided
 
Treatment of Social Phobia With Combined Cognitive Bias Modification and iCBT
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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Social Phobia
  • 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.

  • 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.

  • Experimental: CBM training program variant 1 + iCBT
    Cognitive bias modification training program variant 1 combined with iCBT
    Interventions:
    • Behavioral: Internet-administered cognitive behavioral therapy (iCBT)
    • Behavioral: Cognitive bias modification training program variant 1
  • Experimental: CBM training program variant 2 + iCBT
    Cognitive bias modification training program variant 2 combined with iCBT
    Interventions:
    • Behavioral: Internet-administered cognitive behavioral therapy (iCBT)
    • Behavioral: Cognitive bias modification training program variant 2
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
128
December 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01570400
SOFIE13a
No
Per Carlbring, PhD, Umeå University
Umeå University
Not Provided
Principal Investigator: Per Carlbring, Professor Department of Psychology, Umeå University
Umeå University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP