NCT03140839

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

May 10, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2018

Completed
Last Updated

January 16, 2019

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

April 21, 2017

Last Update Submit

January 15, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in self-reported social anxiety symptoms

    Social Phobia Inventory

    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

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

  • Change in memory narratives and appraisals

    Waterloo Images and Memories Interview

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

Secondary Outcomes (2)

  • Change in behavioral indices of social anxiety

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

  • Change in quality of life

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

Study Arms (3)

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.

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.

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.

Other: Supportive Counselling

Interventions

A stand-alone single session intervention for social anxiety disorder

Also known as: Imagery Rescripting
Imaginal Rescripting

A stand-alone single session intervention for social anxiety disorder

Imaginal Exposure

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

Supportive Counselling

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Active suicidality, psychosis, or an actively-interfering alcohol/substance use disorder.
  • Participant does not endorse mental images/memories

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Waterloo, Ontario, N2L 3G1, Canada

Location

Related Publications (2)

  • 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.

    PMID: 26555157BACKGROUND
  • 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.

    PMID: 21683343BACKGROUND

MeSH Terms

Interventions

Implosive Therapy

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blind to the condition they receive
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to receive one of three conditions, either Imaginal Rescripting, Imaginal Exposure, or Supportive Counselling
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2017

First Posted

May 4, 2017

Study Start

May 10, 2017

Primary Completion

August 23, 2018

Study Completion

August 23, 2018

Last Updated

January 16, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations