Social AnxietyNCT03140839
Treating Negative Mental Images and Memories in Social Anxiety
A study testing Imaginal Rescripting, Imaginal Exposure and Supportive Counselling in people with Social Anxiety, run by University of Waterloo at 1 site in Canada.
Trial summary
The proposed research will study the effects of Imaginal Rescripting (IR) for social anxiety disorder (SAD). IR guides patients to change their memories of past socially painful events. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Social Anxiety
- What is being tested?
- Imaginal Rescripting, Imaginal Exposure and Supportive Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 10 May 2017to 23 Aug 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Principal diagnosis of social anxiety disorder (as per DSM-5)
- Endorsement of relevant images/memories associated with social situations.
- Participants currently undergoing stable drug treatment or psychological treatment for anxiety or mood difficulties may be included in the study if the treatment would not interfere with the study interventions.
Who cannot join
- Active suicidality, psychosis, or an actively-interfering alcohol/substance use disorder.
- Participant does not endorse mental images/memories
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Waterloo Department of Psychology and Centre for Mental Health Research
Waterloo, Ontario, N2L 3G1
About this study
Official title: Understanding the Psychological Effects and Mechanisms of Imagery Rescripting for Social Anxiety Disorder: A Controlled Experimental Study
The proposed research will study the effects of Imaginal Rescripting (IR) for social anxiety disorder (SAD). IR guides patients to change their memories of past socially painful events. Initial studies have found that a single session of IR significantly reduces SAD symptoms, however it is not yet clear how or why IR works and whether its effects are long lasting. To answer these questions, the investigators will randomly assign adults with SAD to receive either IR, or two other types of brief psychological interventions: Imaginal Exposure and Supportive Counselling. Changes in participants' memories, social anxiety symptoms, quality of life, negative beliefs, and social behaviour over the course of a 6-month period will be assessed. This study will provide valuable insight into the short- and long-term effects of IR and clarify the mechanisms through which IR works. Ultimately, this knowledge will enable the development of more effective treatments and prevention programs for SAD.
Read the detailed description
Purpose:
Building upon extensive prior research by the investigators' expert team, the proposed study will examine the effects of Imaginal Rescripting (IR) as a stand-alone single session intervention for social anxiety disorder (SAD). IR is a short but effective cognitive behavioural intervention, which guides patients to change their memories of past socially painful events. The purpose of the study is to examine the effects of IR in relation to two comparison conditions and by doing so also provide much-needed experimental evidence in clinical participants to distinguish between competing theories of treatment mechanisms. Does IR work by altering the content of the memory or simply by changing its meaning or impact, or both? If modifying memory content is important, does IR improve access to more positive memory details that compete with the original negative ones for activation in subsequent contexts or eradicate elements of the original traumatic memory, perhaps via the disruption of memory reconsolidation? The study will take advantage of the recent development and validation of the Waterloo Images and Memories Interview, which enables researchers to measure the accessibility, subjective appraisals, and narrative content of autobiographical memories (and associated mental images) that participants report experiencing. One particularly important outcome generated by the WIMI for the present study involves having trained coders count the number of "episodic" vs. "non-episodic" negative and positive autobiographical memory details present in participants' reported narratives over time.
Research Questions:
The effects of IR will be investigated in comparison to Imaginal Exposure (IE) and Supportive Counselling (SC). IR targets imagery-based mental representations embedded within patients autobiographical memories. In IR, patients progress through 3 distinct phases: (1) Participants "relive" a past negative event in their imagination, (2) are guided to actively change the original memory in their imagination to create more satisfying outcomes, and (3) relive the memory again while incorporating the new information. IE involves repeatedly "reliving" the memory from a first-person perspective and actively considering alternative meanings of the memory, but differs from IR in that the original memory itself is never explicitly modified in any way. SC provides patients with empathic support and controls for non-specific clinical factors such as therapeutic attention and alliance. The research will examine whether IR outperforms these conditions and leads to sustained changes in SAD symptoms, quality of life, and social behaviour. The use of IE as a control condition will help to determine whether the therapeutic effects of IR depend on altering the content of the targeted autobiographical memory rather than just its meaning.
Justification:
Only 3 preliminary studies, including one from the investigators' lab, have examined the effects of IR as a stand-alone intervention for SAD. These studies found that a single 90-min session of IR produced large improvements in SAD symptoms at post-treatment, but both relied exclusively on self-report measures. Moreover, neither study incorporated an active imagery-based control condition against which the specific mechanisms of IR could be experimentally isolated and understood. Understanding the mechanisms of IR will help to facilitate the development of effective treatment and relapse prevention strategies for SAD as well as the future dissemination of efficient but potent CBT interventions to patients diagnosed with SAD.
Objectives:
Capitalizing on innovative methodological advancements in the investigators' lab that enable the precise measurement of patients' memory narratives and appraisals over time, the objective is to elucidate how fear memories are represented in the socially anxious mind, how they change during IR, and how impactful and enduring these effects may be.
- Conditions
- Social Anxiety
- Being tested
- Imaginal Rescripting, Imaginal Exposure, Supportive Counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaginal RescriptingBehavioural
Also called Imagery Rescripting
A stand-alone single session intervention for social anxiety disorder
Imaginal ExposureBehavioural
A stand-alone single session intervention for social anxiety disorder
Supportive CounsellingOther
Non-specific talk therapy focused on non-directive and empathic listening and on supporting patients' existing coping skills and strategies.
| Study group | Role | What they receive |
|---|---|---|
| Imaginal Rescripting | Experimental | Imaginal Rescripting (IR) targets imagery-based mental representations embedded within patients negative autobiographical memories related to social anxiety. In IR, patients progress through 3 distinct phases: (1) They "relive" a past negative event in their imagination, (2) are guided to actively change the original memory in their imagination to create more satisfying outcomes, and (3) relive the memory again while incorporating the new information. The IR intervention will be administered in one 90 minute session. Receives: Behavioral: Imaginal Rescripting |
| Imaginal Exposure | Active comparator | Imaginal Exposure (IE) involves repeatedly "reliving" a negative autobiographical memory related to social anxiety from a first-person perspective and actively considering alternative meanings of the memory, but differs from IR in that the original memory itself is never explicitly modified in any way. The IE intervention will be administered in one 90 minute session. Receives: Behavioral: Imaginal Exposure |
| Supportive Counselling | Placebo comparator | Supportive counselling (SC) provides patients with empathic support regarding a negative autobiographical memory related to social anxiety. The SC condition controls for non-specific clinical factors such as therapeutic attention and alliance. SC will be administered in one 60-90 minute session. Receives: Other: Supportive Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported social anxiety symptoms
Social Phobia Inventory
Measured: Pre-treatment, 1 week, 2 weeks, and 3 months after treatment
Change in clinician-rated social anxiety symptoms
Liebowitz Social Anxiety Scale-Clinician Rated Version
Measured: Pre-treatment, 1 week, 2 weeks, and 3 months after treatment
Change in memory narratives and appraisals
Waterloo Images and Memories Interview
Measured: Pre-treatment, 1 week, 2 weeks, and 3 months after treatment
Secondary outcomes (2)
Change in behavioral indices of social anxiety
Behavioural Assessment Task
Measured: Pre-treatment, 1 week, 2 weeks, and 3 months after treatment
Change in quality of life
Outcome rating scale
Measured: Pre-treatment, 1 week, 2 weeks, and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start10 May 2017
- Primary completion23 Aug 2018
- Study completion23 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Social AnxietyStudies 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
- Model description
- Participants will be randomized to receive one of three conditions, either Imaginal Rescripting, Imaginal Exposure, or Supportive Counselling
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem, University of Toronto, Baycrest
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140839
- Sponsor's protocol ID
- ORE # 22071
- Status last verified
- Oct 2018
- First submitted
- 21 Apr 2017
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reimer SG, Moscovitch DA. The impact of imagery rescripting on memory appraisals and core beliefs in social anxiety disorder. Behav Res Ther. 2015 Dec;75:48-59. doi: 10.1016/j.brat.2015.10.007. Epub 2015 Nov 2.
PubMed 26555157Moscovitch 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 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Psychological Effects and Mechanisms of Imagery Rescripting for Social Anxiety Disorder: A Controlled Experimental Study
- ClinicalTrials.gov ID
- NCT03140839
- Acronym / sponsor ID
- ORE # 22071
- Conditions
- Social Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Hebrew University of Jerusalem, University of Toronto, Baycrest
- Study start
- 10 May 2017 (actual)
- Primary completion
- 23 Aug 2018 (actual)
- Study completion
- 23 Aug 2018 (actual)
- First posted
- 4 May 2017 (actual)
- 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 proposed research will study the effects of Imaginal Rescripting (IR) for social anxiety disorder (SAD). IR guides patients to change their memories of past socially painful events. Initial studies have found that a single session of IR significantly reduces SAD symptoms, however it is not yet clear how or why IR works and whether its effects are long lasting. To answer these questions, the investigators will randomly assign adults with SAD to receive either IR, or two other types of brief psychological interventions: Imaginal Exposure and Supportive Counselling. Changes in participants' memories, social anxiety symptoms, quality of life, negative beliefs, and social behaviour over the course of a 6-month period will be assessed. This study will provide valuable insight into the short- and long-term effects of IR and clarify the mechanisms through which IR works. Ultimately, this knowledge will enable the development of more effective treatments and prevention programs for SAD.
Detailed description
Purpose:
Building upon extensive prior research by the investigators' expert team, the proposed study will examine the effects of Imaginal Rescripting (IR) as a stand-alone single session intervention for social anxiety disorder (SAD). IR is a short but effective cognitive behavioural intervention, which guides patients to change their memories of past socially painful events. The purpose of the study is to examine the effects of IR in relation to two comparison conditions and by doing so also provide much-needed experimental evidence in clinical participants to distinguish between competing theories of treatment mechanisms. Does IR work by altering the content of the memory or simply by changing its meaning or impact, or both? If modifying memory content is important, does IR improve access to more positive memory details that compete with the original negative ones for activation in subsequent contexts or eradicate elements of the original traumatic memory, perhaps via the disruption of memory reconsolidation? The study will take advantage of the recent development and validation of the Waterloo Images and Memories Interview, which enables researchers to measure the accessibility, subjective appraisals, and narrative content of autobiographical memories (and associated mental images) that participants report experiencing. One particularly important outcome generated by the WIMI for the present study involves having trained coders count the number of "episodic" vs. "non-episodic" negative and positive autobiographical memory details present in participants' reported narratives over time.
Research Questions:
The effects of IR will be investigated in comparison to Imaginal Exposure (IE) and Supportive Counselling (SC). IR targets imagery-based mental representations embedded within patients autobiographical memories. In IR, patients progress through 3 distinct phases: (1) Participants "relive" a past negative event in their imagination, (2) are guided to actively change the original memory in their imagination to create more satisfying outcomes, and (3) relive the memory again while incorporating the new information. IE involves repeatedly "reliving" the memory from a first-person perspective and actively considering alternative meanings of the memory, but differs from IR in that the original memory itself is never explicitly modified in any way. SC provides patients with empathic support and controls for non-specific clinical factors such as therapeutic attention and alliance. The research will examine whether IR outperforms these conditions and leads to sustained changes in SAD symptoms, quality of life, and social behaviour. The use of IE as a control condition will help to determine whether the therapeutic effects of IR depend on altering the content of the targeted autobiographical memory rather than just its meaning.
Justification:
Only 3 preliminary studies, including one from the investigators' lab, have examined the effects of IR as a stand-alone intervention for SAD. These studies found that a single 90-min session of IR produced large improvements in SAD symptoms at post-treatment, but both relied exclusively on self-report measures. Moreover, neither study incorporated an active imagery-based control condition against which the specific mechanisms of IR could be experimentally isolated and understood. Understanding the mechanisms of IR will help to facilitate the development of effective treatment and relapse prevention strategies for SAD as well as the future dissemination of efficient but potent CBT interventions to patients diagnosed with SAD.
Objectives:
Capitalizing on innovative methodological advancements in the investigators' lab that enable the precise measurement of patients' memory narratives and appraisals over time, the objective is to elucidate how fear memories are represented in the socially anxious mind, how they change during IR, and how impactful and enduring these effects may be.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants will be randomized to receive one of three conditions, either Imaginal Rescripting, Imaginal Exposure, or Supportive Counselling
| Arm | Type | Receives |
|---|---|---|
| Imaginal Rescripting | Experimental | Behavioral: Imaginal RescriptingImaginal Rescripting (IR) targets imagery-based mental representations embedded within patients negative autobiographical memories related to social anxiety. In IR, patients progress through 3 distinct phases: (1) They "relive" a past negative event in their imagination, (2) are guided to actively change the original memory in their imagination to create more satisfying outcomes, and (3) relive the memory again while incorporating the new information. The IR intervention will be administered in one 90 minute session. |
| Imaginal Exposure | Active comparator | Behavioral: Imaginal ExposureImaginal Exposure (IE) involves repeatedly "reliving" a negative autobiographical memory related to social anxiety from a first-person perspective and actively considering alternative meanings of the memory, but differs from IR in that the original memory itself is never explicitly modified in any way. The IE intervention will be administered in one 90 minute session. |
| Supportive Counselling | Placebo comparator | Other: Supportive CounsellingSupportive counselling (SC) provides patients with empathic support regarding a negative autobiographical memory related to social anxiety. The SC condition controls for non-specific clinical factors such as therapeutic attention and alliance. SC will be administered in one 60-90 minute session. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Principal diagnosis of social anxiety disorder (as per DSM-5)
- Endorsement of relevant images/memories associated with social situations.
- Participants currently undergoing stable drug treatment or psychological treatment for anxiety or mood difficulties may be included in the study if the treatment would not interfere with the study interventions.
Key exclusion criteria (2 listed)
- Active suicidality, psychosis, or an actively-interfering alcohol/substance use disorder.
- Participant does not endorse mental images/memories
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 |
|---|---|---|
| Imaginal RescriptingAlso: Imagery RescriptingA stand-alone single session intervention for social anxiety disorder | Behavioural | Imaginal Rescripting |
| Imaginal ExposureA stand-alone single session intervention for social anxiety disorder | Behavioural | Imaginal Exposure |
| Supportive CounsellingNon-specific talk therapy focused on non-directive and empathic listening and on supporting patients' existing coping skills and strategies. | Other | Supportive Counselling |
Primary outcome
Change in self-reported social anxiety symptoms
Time frame: Pre-treatment, 1 week, 2 weeks, and 3 months after treatment
Social Phobia Inventory
Change in clinician-rated social anxiety symptoms
Time frame: Pre-treatment, 1 week, 2 weeks, and 3 months after treatment
Liebowitz Social Anxiety Scale-Clinician Rated Version
Change in memory narratives and appraisals
Time frame: Pre-treatment, 1 week, 2 weeks, and 3 months after treatment
Waterloo Images and Memories Interview
2 secondary outcomes
Change in behavioral indices of social anxiety
Time frame: Pre-treatment, 1 week, 2 weeks, and 3 months after treatment
Change in quality of life
Time frame: Pre-treatment, 1 week, 2 weeks, and 3 months after treatment
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 16 Jan 2019.
- Background: PubMed 26555157Reimer SG, Moscovitch DA. The impact of imagery rescripting on memory appraisals and core beliefs in social anxiety disorder. Behav Res Ther. 2015 Dec;75:48-59. doi: 10.1016/j.brat.2015.10.007. Epub 2015 Nov 2.
- Background: PubMed 21683343Moscovitch 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaginal Rescripting, Imaginal Exposure and Supportive Counselling in people with Social Anxiety, run by University of Waterloo at 1 site in Canada.
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 2 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 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Change in self-reported social anxiety symptoms (time frame: Pre-treatment, 1 week, 2 weeks, and 3 months after treatment). The study lists 3 primary outcomes in all. 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 NCT03140839, which also lists 2 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 16 Jan 2019.