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

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ClinicalTrials.gov Identifier: NCT02659436
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):
Karen Rowa, St. Joseph's Healthcare Hamilton

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.

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Other: Verbal-linguistic CBT Other: Imagery-based CBT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Imagery-based CBT for Social Anxiety Disorder: Piloting a Treatment Augmentation Protocol
Study Start Date : January 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: Verbal-linguistic CBT
Participants will receive 4 sessions of verbal cognitive restructuring and exposure therapy delivered in an individual therapy format.
Other: Verbal-linguistic CBT
Participants will receive 4 sessions of individual therapy focused on traditional cognitive restructuring and exposure therapy.

Experimental: Imagery-based CBT
Participants will receive 4 sessions of imagery-based cognitive work and behavioural experiments delivered in an individual therapy format.
Other: Imagery-based CBT
Participants will receive 4 sessions of individual therapy focused on imagery-based cognitive work and behavioural experiments.




Primary Outcome Measures :
  1. Social Phobia Inventory [ 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. ]
    Measures social anxiety symptoms


Secondary Outcome Measures :
  1. Vividness of Visual Imagery Questionnaire [ 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. ]
    Measures the ability to visualize several visual images

  2. Homework Adherence Scale [ 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. ]
    Measures the quality of homework completion

  3. Treatment Satisfaction Scale [ 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. ]
    Measures the participant's satisfaction with their treatment

  4. Brief Fear of Negative Evaluation Scale [ 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. ]
    Measures fears about being negatively evaluated by others

  5. Illness Intrusiveness Rating Scale [ 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. ]
    Measures how much anxiety interferes with functioning



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02659436


Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Investigators
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Principal Investigator: Karen Rowa, Ph. D St. Joseph's Healthcare Hamilton
Publications:
American Psychiatric Association (2013). Diagnostic and statistical manual of mental disorders (5th edition). Washington, DC: APA.
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
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

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Responsible Party: Karen Rowa, Associate Professor and Psychologist, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT02659436    
Other Study ID Numbers: 0986
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016
Keywords provided by Karen Rowa, St. Joseph's Healthcare Hamilton:
Cognitive Behavioural Therapy
Additional relevant MeSH terms:
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Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders