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Completed

NCT Number: NCT03140839

Treating Negative Mental Images and Memories in Social Anxiety

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Waterloo, Ontario, N2L 3G1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imaginal Rescripting

Behavioral

A stand-alone single session intervention for social anxiety disorder

Other names: Imagery Rescripting

Imaginal exposure

Behavioral

A stand-alone single session intervention for social anxiety disorder

Supportive Counselling

Other

Non-specific talk therapy focused on non-directive and empathic listening and on supporting patients' existing coping skills and strategies.

Primary outcomes

  1. Change in self-reported social anxiety symptoms

    Time frame: Pre-treatment, 1 week, 2 weeks, and 3 months after treatment

    Social Phobia Inventory

  2. 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

  3. Change in memory narratives and appraisals

    Time frame: Pre-treatment, 1 week, 2 weeks, and 3 months after treatment

    Waterloo Images and Memories Interview

Secondary outcomes

  1. Change in behavioral indices of social anxiety

    Time frame: Pre-treatment, 1 week, 2 weeks, and 3 months after treatment

    Behavioural Assessment Task

  2. Change in quality of life

    Time frame: Pre-treatment, 1 week, 2 weeks, and 3 months after treatment

    Outcome rating scale

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Baycrest
  • Hebrew University of Jerusalem
  • University of Toronto

Registry information

Official study title

Understanding the Psychological Effects and Mechanisms of Imagery Rescripting for Social Anxiety Disorder: A Controlled Experimental Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 4, 2017
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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