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Imagery-based CBT for Social Anxiety Disorder: Piloting a Treatment Augmentation Protocol

Primary Purpose

Social Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Verbal-linguistic CBT
Imagery-based CBT
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Cognitive Behavioural Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Completed eight out of twelve sessions of standard verbal-linguistic group cognitive behavioural therapy for social anxiety disorder
  • Presented with a Social Phobia Inventory (SPIN) score of greater than 19 post-treatment
  • Interested in further treatment

Exclusion Criteria:

  • Has another mental health concern of greater importance than social anxiety disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Verbal-linguistic CBT

    Imagery-based CBT

    Arm Description

    Participants will receive 4 sessions of verbal cognitive restructuring and exposure therapy delivered in an individual therapy format.

    Participants will receive 4 sessions of imagery-based cognitive work and behavioural experiments delivered in an individual therapy format.

    Outcomes

    Primary Outcome Measures

    Social Phobia Inventory
    Measures social anxiety symptoms

    Secondary Outcome Measures

    Vividness of Visual Imagery Questionnaire
    Measures the ability to visualize several visual images
    Homework Adherence Scale
    Measures the quality of homework completion
    Treatment Satisfaction Scale
    Measures the participant's satisfaction with their treatment
    Brief Fear of Negative Evaluation Scale
    Measures fears about being negatively evaluated by others
    Illness Intrusiveness Rating Scale
    Measures how much anxiety interferes with functioning

    Full Information

    First Posted
    January 14, 2016
    Last Updated
    December 28, 2016
    Sponsor
    St. Joseph's Healthcare Hamilton
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02659436
    Brief Title
    Imagery-based CBT for Social Anxiety Disorder: Piloting a Treatment Augmentation Protocol
    Official Title
    Imagery-based CBT for Social Anxiety Disorder: Piloting a Treatment Augmentation Protocol
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St. Joseph's Healthcare Hamilton

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this pilot study is to explore whether there is a differential impact of verbal versus imagery-based cognitive behavioural therapy (CBT) as a treatment augmentation strategy for individuals with social anxiety disorder (SAD). Clients who have not demonstrated clinically significant change following group CBT for SAD will receive four additional sessions of either verbal-based CBT or imagery-based CBT. We hypothesize that that individuals who receive imagery-based CBT will experience even stronger improvements and be more satisfied with their treatment than individuals who received traditional verbal-linguistic CBT.
    Detailed Description
    Social Anxiety Disorder (SAD) is a debilitating disorder, marked by significant functional impairment and high personal distress for those who suffer. Psychological treatment for SAD has traditionally been verbal-linguistic cognitive behavioural therapy (CBT). However, a significant number of individuals who complete CBT for SAD do not achieve full response and continue to struggle with significant residual symptoms. One innovation that has received attention recently in the literature is using imagery-based CBT as a way to augment treatment outcome in SAD. Results from a pilot and benchmarking study suggest that participants who received imagery-based CBT were more likely to complete treatment than those who received traditional CBT and treatment outcome was strong for both groups, but stronger in the imagery-based CBT group. However, before re-training hundreds of practitioners in using a completely novel treatment approach, it is important to see if a brief augmentation of traditional CBT programs is effective in producing further change for individuals with residual symptoms after group CBT. It is possible that individuals just require a few more sessions of the same verbal-linguistic CBT to consolidate treatment gains or work on lingering triggers of anxiety. It is also possible that more of the same is not as valuable as offering therapy using a different modality, such as imagery. Therefore, we propose to evaluate a brief imagery-based augmentation of traditional group CBT to explore its effects on further symptom reduction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Social Anxiety Disorder
    Keywords
    Cognitive Behavioural Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Verbal-linguistic CBT
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive 4 sessions of verbal cognitive restructuring and exposure therapy delivered in an individual therapy format.
    Arm Title
    Imagery-based CBT
    Arm Type
    Experimental
    Arm Description
    Participants will receive 4 sessions of imagery-based cognitive work and behavioural experiments delivered in an individual therapy format.
    Intervention Type
    Other
    Intervention Name(s)
    Verbal-linguistic CBT
    Intervention Description
    Participants will receive 4 sessions of individual therapy focused on traditional cognitive restructuring and exposure therapy.
    Intervention Type
    Other
    Intervention Name(s)
    Imagery-based CBT
    Intervention Description
    Participants will receive 4 sessions of individual therapy focused on imagery-based cognitive work and behavioural experiments.
    Primary Outcome Measure Information:
    Title
    Social Phobia Inventory
    Description
    Measures social anxiety symptoms
    Time Frame
    This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
    Secondary Outcome Measure Information:
    Title
    Vividness of Visual Imagery Questionnaire
    Description
    Measures the ability to visualize several visual images
    Time Frame
    This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
    Title
    Homework Adherence Scale
    Description
    Measures the quality of homework completion
    Time Frame
    This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
    Title
    Treatment Satisfaction Scale
    Description
    Measures the participant's satisfaction with their treatment
    Time Frame
    This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
    Title
    Brief Fear of Negative Evaluation Scale
    Description
    Measures fears about being negatively evaluated by others
    Time Frame
    This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.
    Title
    Illness Intrusiveness Rating Scale
    Description
    Measures how much anxiety interferes with functioning
    Time Frame
    This will be administered at the end of the 4 session protocol which will take place approximately 4 -6 weeks after entry into the study.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Completed eight out of twelve sessions of standard verbal-linguistic group cognitive behavioural therapy for social anxiety disorder Presented with a Social Phobia Inventory (SPIN) score of greater than 19 post-treatment Interested in further treatment Exclusion Criteria: Has another mental health concern of greater importance than social anxiety disorder
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Karen Rowa, Ph. D
    Organizational Affiliation
    St. Joseph's Healthcare Hamilton
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    Citation
    American Psychiatric Association (2013). Diagnostic and statistical manual of mental disorders (5th edition). Washington, DC: APA.
    Results Reference
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    PubMed Identifier
    9612449
    Citation
    Antony MM, Roth D, Swinson RP, Huta V, Devins GM. Illness intrusiveness in individuals with panic disorder, obsessive-compulsive disorder, or social phobia. J Nerv Ment Dis. 1998 May;186(5):311-5. doi: 10.1097/00005053-199805000-00008.
    Results Reference
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    Citation
    Bieling, P.J., Rowa, K., Antony, M.M., Summerfeldt, L.J., & Swinson, R.P. (2001). Factor structure of the Illness Intrusiveness Ratings Scale in patients diagnosed with anxiety disorders. Journal of Psychopathology and Behavioral Assessment, 23, 223-230. doi: 10.1023/A:1012723318964
    Results Reference
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    PubMed Identifier
    16675196
    Citation
    Carleton RN, Collimore KC, Asmundson GJ. Social anxiety and fear of negative evaluation: construct validity of the BFNE-II. J Anxiety Disord. 2007;21(1):131-41. doi: 10.1016/j.janxdis.2006.03.010. Epub 2006 May 3. Erratum In: J Anxiety Disord. 2007;21(4):600-1.
    Results Reference
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    PubMed Identifier
    7614328
    Citation
    Devins GM. Illness intrusiveness and the psychosocial impact of lifestyle disruptions in chronic life-threatening disease. Adv Ren Replace Ther. 1994 Oct;1(3):251-63. doi: 10.1016/s1073-4449(12)80007-0.
    Results Reference
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    PubMed Identifier
    11567172
    Citation
    Devins GM, Dion R, Pelletier LG, Shapiro CM, Abbey S, Raiz LR, Binik YM, McGowan P, Kutner NG, Beanlands H, Edworthy SM. Structure of lifestyle disruptions in chronic disease: a confirmatory factor analysis of the Illness Intrusiveness Ratings Scale. Med Care. 2001 Oct;39(10):1097-104. doi: 10.1097/00005650-200110000-00007.
    Results Reference
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    PubMed Identifier
    10846808
    Citation
    Hackmann A, Clark DM, McManus F. Recurrent images and early memories in social phobia. Behav Res Ther. 2000 Jun;38(6):601-10. doi: 10.1016/s0005-7967(99)00161-8.
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    PubMed Identifier
    12880646
    Citation
    Hirsch CR, Clark DM, Mathews A, Williams R. Self-images play a causal role in social phobia. Behav Res Ther. 2003 Aug;41(8):909-21. doi: 10.1016/s0005-7967(02)00103-1.
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    PubMed Identifier
    19222316
    Citation
    Holmes EA, Lang TJ, Shah DM. Developing interpretation bias modification as a "cognitive vaccine" for depressed mood: imagining positive events makes you feel better than thinking about them verbally. J Abnorm Psychol. 2009 Feb;118(1):76-88. doi: 10.1037/a0012590.
    Results Reference
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    Citation
    Leary, M. R. (1983). A brief version of the Fear of Negative Evaluation Scale. Personality and Social Psychology Bulletin, 9, 371-376. doi: 10.1177/0146167283093007
    Results Reference
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    PubMed Identifier
    24561919
    Citation
    McEvoy PM, Saulsman LM. Imagery-enhanced cognitive behavioural group therapy for social anxiety disorder: a pilot study. Behav Res Ther. 2014 Apr;55:1-6. doi: 10.1016/j.brat.2014.01.006. Epub 2014 Feb 7.
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    PubMed Identifier
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    Citation
    McEvoy PM, Erceg-Hurn DM, Saulsman LM, Thibodeau MA. Imagery enhancements increase the effectiveness of cognitive behavioural group therapy for social anxiety disorder: a benchmarking study. Behav Res Ther. 2015 Feb;65:42-51. doi: 10.1016/j.brat.2014.12.011. Epub 2014 Dec 27.
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    Citation
    Moscovitch DA, Gavric DL, Merrifield C, Bielak T, Moscovitch M. Retrieval properties of negative vs. positive mental images and autobiographical memories in social anxiety: outcomes with a new measure. Behav Res Ther. 2011 Aug;49(8):505-17. doi: 10.1016/j.brat.2011.05.009. Epub 2011 May 26.
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    Imagery-based CBT for Social Anxiety Disorder: Piloting a Treatment Augmentation Protocol

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