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
About this trial
This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Cognitive Behavioural Therapy
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
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
NCT ID
NCT02659436
First Posted
January 14, 2016
Last Updated
December 28, 2016
Sponsor
St. Joseph's Healthcare Hamilton
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
background
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
background
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
background
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
background
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
background
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
background
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.
Results Reference
background
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.
Results Reference
background
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
background
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
background
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.
Results Reference
background
PubMed Identifier
25569339
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.
Results Reference
background
PubMed Identifier
21683343
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.
Results Reference
background
Learn more about this trial
Imagery-based CBT for Social Anxiety Disorder: Piloting a Treatment Augmentation Protocol
We'll reach out to this number within 24 hrs