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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03140839
Other study ID # ORE # 22071
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 10, 2017
Est. completion date August 23, 2018

Study information

Verified date October 2018
Source University of Waterloo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date August 23, 2018
Est. primary completion date August 23, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Active suicidality, psychosis, or an actively-interfering alcohol/substance use disorder.

- Participant does not endorse mental images/memories

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Imaginal Rescripting
A stand-alone single session intervention for social anxiety disorder
Imaginal Exposure
A stand-alone single session intervention for social anxiety disorder
Other:
Supportive Counselling
Non-specific talk therapy focused on non-directive and empathic listening and on supporting patients' existing coping skills and strategies.

Locations

Country Name City State
Canada University of Waterloo Department of Psychology and Centre for Mental Health Research Waterloo Ontario

Sponsors (4)

Lead Sponsor Collaborator
University of Waterloo Baycrest, Hebrew University of Jerusalem, University of Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in self-reported social anxiety symptoms Social Phobia Inventory Pre-treatment, 1 week, 2 weeks, and 3 months after treatment
Primary Change in clinician-rated social anxiety symptoms Liebowitz Social Anxiety Scale-Clinician Rated Version Pre-treatment, 1 week, 2 weeks, and 3 months after treatment
Primary Change in memory narratives and appraisals Waterloo Images and Memories Interview Pre-treatment, 1 week, 2 weeks, and 3 months after treatment
Secondary Change in behavioral indices of social anxiety Behavioural Assessment Task Pre-treatment, 1 week, 2 weeks, and 3 months after treatment
Secondary Change in quality of life Outcome rating scale Pre-treatment, 1 week, 2 weeks, and 3 months after treatment
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