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Treating Negative Mental Images and Memories in Social Anxiety

Primary Purpose

Social Anxiety

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Imaginal Rescripting
Imaginal Exposure
Supportive Counselling
Sponsored by
University of Waterloo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Waterloo Department of Psychology and Centre for Mental Health Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Imaginal Rescripting

Imaginal Exposure

Supportive Counselling

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in self-reported social anxiety symptoms
Social Phobia Inventory
Change in clinician-rated social anxiety symptoms
Liebowitz Social Anxiety Scale-Clinician Rated Version
Change in memory narratives and appraisals
Waterloo Images and Memories Interview

Secondary Outcome Measures

Change in behavioral indices of social anxiety
Behavioural Assessment Task
Change in quality of life
Outcome rating scale

Full Information

First Posted
April 21, 2017
Last Updated
January 15, 2019
Sponsor
University of Waterloo
Collaborators
Hebrew University of Jerusalem, University of Toronto, Baycrest
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1. Study Identification

Unique Protocol Identification Number
NCT03140839
Brief Title
Treating Negative Mental Images and Memories in Social Anxiety
Official Title
Understanding the Psychological Effects and Mechanisms of Imagery Rescripting for Social Anxiety Disorder: A Controlled Experimental Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
August 23, 2018 (Actual)
Study Completion Date
August 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Waterloo
Collaborators
Hebrew University of Jerusalem, University of Toronto, Baycrest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to receive one of three conditions, either Imaginal Rescripting, Imaginal Exposure, or Supportive Counselling
Masking
Participant
Masking Description
Participants will be blind to the condition they receive
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imaginal Rescripting
Arm Type
Experimental
Arm Description
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.
Arm Title
Imaginal Exposure
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Supportive Counselling
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Imaginal Rescripting
Other Intervention Name(s)
Imagery Rescripting
Intervention Description
A stand-alone single session intervention for social anxiety disorder
Intervention Type
Behavioral
Intervention Name(s)
Imaginal Exposure
Intervention Description
A stand-alone single session intervention for social anxiety disorder
Intervention Type
Other
Intervention Name(s)
Supportive Counselling
Intervention Description
Non-specific talk therapy focused on non-directive and empathic listening and on supporting patients' existing coping skills and strategies.
Primary Outcome Measure Information:
Title
Change in self-reported social anxiety symptoms
Description
Social Phobia Inventory
Time Frame
Pre-treatment, 1 week, 2 weeks, and 3 months after treatment
Title
Change in clinician-rated social anxiety symptoms
Description
Liebowitz Social Anxiety Scale-Clinician Rated Version
Time Frame
Pre-treatment, 1 week, 2 weeks, and 3 months after treatment
Title
Change in memory narratives and appraisals
Description
Waterloo Images and Memories Interview
Time Frame
Pre-treatment, 1 week, 2 weeks, and 3 months after treatment
Secondary Outcome Measure Information:
Title
Change in behavioral indices of social anxiety
Description
Behavioural Assessment Task
Time Frame
Pre-treatment, 1 week, 2 weeks, and 3 months after treatment
Title
Change in quality of life
Description
Outcome rating scale
Time Frame
Pre-treatment, 1 week, 2 weeks, and 3 months after treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Waterloo Department of Psychology and Centre for Mental Health Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26555157
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.
Results Reference
background
PubMed Identifier
21683343
Citation
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.
Results Reference
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Treating Negative Mental Images and Memories in Social Anxiety

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