NCT02659436

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 29, 2016

Status Verified

December 1, 2016

Enrollment Period

11 months

First QC Date

January 14, 2016

Last Update Submit

December 28, 2016

Conditions

Keywords

Cognitive Behavioural Therapy

Outcome Measures

Primary Outcomes (1)

  • Social Phobia Inventory

    Measures social anxiety symptoms

    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 Outcomes (5)

  • Vividness of Visual Imagery Questionnaire

    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.

  • Homework Adherence Scale

    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.

  • Treatment Satisfaction Scale

    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.

  • Brief Fear of Negative Evaluation Scale

    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.

  • Illness Intrusiveness Rating Scale

    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.

Study Arms (2)

Verbal-linguistic CBT

ACTIVE COMPARATOR

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

Other: Verbal-linguistic CBT

Imagery-based CBT

EXPERIMENTAL

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

Other: Imagery-based CBT

Interventions

Participants will receive 4 sessions of individual therapy focused on traditional cognitive restructuring and exposure therapy.

Verbal-linguistic CBT

Participants will receive 4 sessions of individual therapy focused on imagery-based cognitive work and behavioural experiments.

Imagery-based CBT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • American Psychiatric Association (2013). Diagnostic and statistical manual of mental disorders (5th edition). Washington, DC: APA.

    BACKGROUND
  • 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.

    PMID: 9612449BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 16675196BACKGROUND
  • 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.

    PMID: 7614328BACKGROUND
  • 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.

    PMID: 11567172BACKGROUND
  • 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.

    PMID: 10846808BACKGROUND
  • 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.

    PMID: 12880646BACKGROUND
  • 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.

    PMID: 19222316BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 24561919BACKGROUND
  • 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.

    PMID: 25569339BACKGROUND
  • 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.

    PMID: 21683343BACKGROUND

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Karen Rowa, Ph. D

    St. Joseph's Healthcare Hamilton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Psychologist

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 20, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 29, 2016

Record last verified: 2016-12