Imagery Rescripting and Imaginal Exposure for Social Anxiety: Mechanisms and Outcomes in an Analog Sample

October 25, 2022 updated by: Jonathan D. Huppert, Hebrew University of Jerusalem

Imagery Based Interventions for the Treatment of Anxiety Related Disorders: Mechanisms and Optimizing Outcomes

This study will recruit 100 participants who self-report high symptoms of social anxiety (Social phobia inventory >30). Participants will be randomly assigned to receive either one analog intervention of Imagery Rescripting (IR) or Imaginal Exposure. We will test the efficacy and mechanisms behind each interventions.

Study Overview

Detailed Description

After being informed about the study potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. They will be randomly assigned to two conditions (Imagery rescripting Vs. Imaginal exposure) at a 1:1 ratio. Participants will attend three ~1 hour online ZOOM sessions (pre-assessment and measurement, intervention, and post assessment and measurement).

Assessors will be blind to the treatment condition.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Jerusalem, Israel, 9190501
        • Recruiting
        • Hebrew University of Jerusalem
        • Contact:
        • Principal Investigator:
          • Jonathan D Huppert, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: SPIN scores >= 30 -

Exclusion Criteria:

can't report a negative imagery related to a future social scenario. Attending active psychotherapy sessions.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Imaginal exposure
A behavioral intervention in imagery
Participants in this arm will be asked to decide alongside with the intervention provider (a clinical PhD student or M.A student under the supervision of the principal investigator) to imagine a script based on a future distressing anxiety provoking scenarios multiple times while honing in on the most negative aspects.
Experimental: Imagery rescripting
A different behavioral intervention in imagery
Participants in this arm will be asked to decide alongside with the intervention provider (a clinical PhD student or M.A student under the supervision of the principal investigator) o imagine a script based on a future distressing anxiety provoking scenarios one time while honing in on the most negative aspects. Afterwards they will insert changes into the script that try to help them cope in the imagery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the Social phobia inventory (SPIN) at the follow-up session
Time Frame: Will be measured at Baseline (6,9, or 12 days before intervention), Post-intervention (immediately after the intervention) and Follow-up ( 7 days after the intervention)

The SPIN is a validated self-report instrument assessing average social phobia symptom intensity over the past week. possible scores range from 0 (not at all) to 4 (Extremly).

change = (follow-up score - Baseline Score)

Will be measured at Baseline (6,9, or 12 days before intervention), Post-intervention (immediately after the intervention) and Follow-up ( 7 days after the intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in the Thought fusion inventory (TFI) at the follow-up session
Time Frame: Will be measured at Baseline (6,9, or 12 days before intervention), Post-intervention (immediately after the intervention) and Follow-up ( 7 days after the intervention)

The TFI is a validated 14 item self-reported instrument assessing average belief in statement that describe the effects of thoughts on reality, objects and actions. Possible scores range from 0 (Do not believe at all) to 100 (completely convinced it is true) in intervals of 10.

change = Follow-up - Baseline Score.

Will be measured at Baseline (6,9, or 12 days before intervention), Post-intervention (immediately after the intervention) and Follow-up ( 7 days after the intervention)
Change from Baseline in the White Bear Suppresion inventory (WBSI) at the follow-up session
Time Frame: Will be measured at Baseline (6,9, or 12 days before intervention), Post-intervention (immediately after the intervention) and Follow-up ( 7 days after the intervention)

The WBSI is a validated 15 item self-reported instrument assessing average tendency to suppress mental thoughts. Possible scores range from 0 (Do not agree) to 5 (very much agree).

change = Follow-up - Baseline Score.

Will be measured at Baseline (6,9, or 12 days before intervention), Post-intervention (immediately after the intervention) and Follow-up ( 7 days after the intervention)
Change from Baseline in the Positive and Negative Affect Scale (PANAS) international version short form (10 items from the negative subscale only) at the follow-up session
Time Frame: Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)

The PANAS International short form is a validated 10 item self-reported instrument assessing emotions after at a certain point in time. Possible scores range from 0 (Not at all) to 5 (Extremely). It will be assessed right after the participant describes the script.

change = Follow-up - Baseline Score.

Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)
Change from Baseline to follow-up in the amount of negative and positive/neutral content details the participant provides while describing the negative imagery. The imagery will be probed using the Waterloo Image and Memories Interview (WIMI).
Time Frame: Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)
The WIMI is a validated 10 item interview for assessing content of imagery. valence of the details will be scored using a trained coder. change = Follow-up - Baseline Score.
Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)
Change from Baseline to follow-up in negativity of the core-beliefs that the participant link to the negative imagery provided in the WIMI.
Time Frame: Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)

The WIMI is a validated 10 item interview for assessing content of imagery and core-beliefs.

Core beliefs are related to the participant perception of himself, others and the world.

valence of the beliefs will be scored using a trained coder. change = Follow-up - Baseline Score.

Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)
imaginal Behavioral Approach Test (iBAT) that measures the participant's willingness to interact with pre-scripted distressing scenarios in imagination
Time Frame: Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)

The iBAT is currently being developed in our lab. The more levels the participants passes (listen to imaginal scenario in full without pressing "skip") the higher the score (from 0 to 10)

Recruitment is under way and pre-registration is available at the open science frame work website:

https://osf.io/bp42h/?view_only=5211617cedf94f71a4daa746e98d924a

Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)
Sentence Completion Task (SCT). Measures participants automatic interpretation bias while being presented with 10 ambiguous social scenarios.
Time Frame: Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)

The SCT has been found to correlate with social anxiety symptoms and differentiate between clinical and non clinical population.

participants enters words that complete scenario described in a sentence. Participant's answers are coded to negative, positive and neutral valence. Then, the participant ratio negative bias is calculated from 0 (complete positive bias) to 1 (complete negative bias)

Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)
The Patient's Experience of Attunement and Responsiveness Scale (PEAR) measures participants' feelings of acceptance by the intervention and interview providers
Time Frame: Will be measured at Baseline (6,9, or 12 days before intervention), Post-intervention (immediately after the intervention) and Follow-up ( 7 days after the intervention)
the PEAR is a well validated self-report instrument. It has 20 items total. Each item is scored from 0 (not at all) to 3 (very much)
Will be measured at Baseline (6,9, or 12 days before intervention), Post-intervention (immediately after the intervention) and Follow-up ( 7 days after the intervention)
The Brief core schema scale (BCSS) measures participants' self beliefs about themselves and others.
Time Frame: Will be measured at Baseline (6,9, or 12 days before intervention), Post-intervention (immediately after the intervention) and Follow-up ( 7 days after the intervention)
the BCSS is a well validated self-report instrument. It has 24 items total. Each item is scored from 1 (believe it slightly) to 3 (believe it totally)
Will be measured at Baseline (6,9, or 12 days before intervention), Post-intervention (immediately after the intervention) and Follow-up ( 7 days after the intervention)
Change across time in the Mini Social phobia inventory - revised (mini SPIN-R) from baseline to pre-treatment and from pre-treatment to follow-up.
Time Frame: Daily, from Baseline to follow-up (a total of 14, 17, or 20 days)

The Mini SPIN-R is a validated self-report instrument assessing average social phobia symptom intensity over the past day. possible scores range from 0 (not at all) to 4 (Extremly).

measured once at the end of each day.

Daily, from Baseline to follow-up (a total of 14, 17, or 20 days)
Daily questionnaire about negative intrusive imagery in general and specific to the imagery provided in the interview.
Time Frame: Daily, from Baseline to follow-up (a total of 14, 17, or 20 days)
Participants are asked alongside the MINI-SPIN-R (see above) whether they had negative imagery during that day (In general) or the specific image they provided (specific). If the report they did experience images they rate two items from the TFI and two items from WBSI adapted for daily measurment. One item about feelings of mastery on the image. 4 items from the BCSS (2 related to the self, one negative and one positive and 2 related to others, one negative and one positive belief). With regards to the specific image they also report on a 0-100 analog scale how vivid, intrusive, distressing that image was for them.
Daily, from Baseline to follow-up (a total of 14, 17, or 20 days)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
Time Frame: Baseline only
This interview is based on DSM-5 diagnostic criteria. It will allow us to detect the presence of social anxiety disorder before the start of treatment.
Baseline only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jonathan D Huppert, PhD, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2021

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

November 8, 2020

First Submitted That Met QC Criteria

November 13, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • isf2157/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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