Social Anxiety DisorderNCT02659436
Imagery-based CBT for Social Anxiety Disorder: Piloting a Treatment Augmentation Protocol
A study testing Verbal-linguistic CBT and Imagery-based CBT in people with Social Anxiety Disorder, run by St. Joseph's Healthcare Hamilton.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Verbal-linguistic CBT and Imagery-based CBT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Has another mental health concern of greater importance than social anxiety disorder
About this study
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.
Read the 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.
- Conditions
- Social Anxiety Disorder
- Being tested
- Verbal-linguistic CBT, Imagery-based CBT
- Keywords
- Cognitive Behavioural Therapy
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal-linguistic CBTOther
Participants will receive 4 sessions of individual therapy focused on traditional cognitive restructuring and exposure therapy.
Imagery-based CBTOther
Participants will receive 4 sessions of individual therapy focused on imagery-based cognitive work and behavioural experiments.
| Study group | Role | What they receive |
|---|---|---|
| Verbal-linguistic CBT | Active comparator | Participants will receive 4 sessions of verbal cognitive restructuring and exposure therapy delivered in an individual therapy format. Receives: 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. Receives: Other: Imagery-based CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Phobia Inventory
Measures social anxiety symptoms
Measured: 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
Measures the ability to visualize several visual images
Measured: 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
Measures the quality of homework completion
Measured: 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
Measures the participant's satisfaction with their treatment
Measured: 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
Measures fears about being negatively evaluated by others
Measured: 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
Measures how much anxiety interferes with functioning
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Rowa, St. Joseph's Healthcare Hamilton
- Investigators
- Karen Rowa, Ph. D, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659436
- Sponsor's protocol ID
- 0986
- Status last verified
- Dec 2016
- First submitted
- 14 Jan 2016
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
American Psychiatric Association (2013). Diagnostic and statistical manual of mental disorders (5th edition). Washington, DC: APA.
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.
PubMed 9612449Bieling, 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
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.
PubMed 16675196Devins 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.
PubMed 7614328Devins 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.
PubMed 11567172Hackmann 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.
PubMed 10846808Hirsch 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.
PubMed 12880646Holmes 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.
PubMed 19222316Leary, 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
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.
PubMed 24561919McEvoy 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.
PubMed 25569339Moscovitch 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.
PubMed 21683343
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imagery-based CBT for Social Anxiety Disorder: Piloting a Treatment Augmentation Protocol
- ClinicalTrials.gov ID
- NCT02659436
- Acronym / sponsor ID
- 0986
- Conditions
- Social Anxiety Disorder
- Keywords
- Cognitive Behavioural Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verbal-linguistic CBT | Active comparator | Other: Verbal-linguistic CBTParticipants will receive 4 sessions of verbal cognitive restructuring and exposure therapy delivered in an individual therapy format. |
| Imagery-based CBT | Experimental | Other: Imagery-based CBTParticipants will receive 4 sessions of imagery-based cognitive work and behavioural experiments delivered in an individual therapy format. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Has another mental health concern of greater importance than social anxiety disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verbal-linguistic CBTParticipants will receive 4 sessions of individual therapy focused on traditional cognitive restructuring and exposure therapy. | Other | Verbal-linguistic CBT |
| Imagery-based CBTParticipants will receive 4 sessions of individual therapy focused on imagery-based cognitive work and behavioural experiments. | Other | Imagery-based CBT |
Primary outcome
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
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- BackgroundAmerican Psychiatric Association (2013). Diagnostic and statistical manual of mental disorders (5th edition). Washington, DC: APA.
- Background: PubMed 9612449Antony 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.
- BackgroundBieling, 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: PubMed 16675196Carleton 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.
- Background: PubMed 7614328Devins 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.
- Background: PubMed 11567172Devins 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.
- Background: PubMed 10846808Hackmann 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.
- Background: PubMed 12880646Hirsch 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.
- Background: PubMed 19222316Holmes 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.
- BackgroundLeary, 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: PubMed 24561919McEvoy 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.
- Background: PubMed 25569339McEvoy 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Rowa, Ph. D principal investigator
St. Joseph's Healthcare Hamilton
Questions about this trial
What is this clinical trial studying?
A study testing Verbal-linguistic CBT and Imagery-based CBT in people with Social Anxiety Disorder, run by St. Joseph's Healthcare Hamilton.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02659436, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2016.