Back to results

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

Primary Purpose

Social Anxiety

Status

Recruiting

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Imaginal exposure one-session

Imagery rescriptinf one-session

About this trial

This is an interventional treatment trial for Social Anxiety focused on measuring Social anxiety symptoms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: SPIN scores >= 30 -

Exclusion Criteria:

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

Sites / Locations

Hebrew University of JerusalemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Imaginal exposure

Imagery rescripting

Arm Description

A behavioral intervention in imagery

A different behavioral intervention in imagery

Outcomes

Primary Outcome Measures

Change from baseline in the Social phobia inventory (SPIN) at the follow-up session

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)

Secondary Outcome Measures

Change from Baseline in the Thought fusion inventory (TFI) at the follow-up session

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.

Change from Baseline in the White Bear Suppresion inventory (WBSI) at the follow-up session

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.

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

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.

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).

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.

Change from Baseline to follow-up in negativity of the core-beliefs that the participant link to the negative imagery provided in the WIMI.

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.

imaginal Behavioral Approach Test (iBAT) that measures the participant's willingness to interact with pre-scripted distressing scenarios in imagination

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

Sentence Completion Task (SCT). Measures participants automatic interpretation bias while being presented with 10 ambiguous social scenarios.

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)

The Patient's Experience of Attunement and Responsiveness Scale (PEAR) measures participants' feelings of acceptance by the intervention and interview providers

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)

The Brief core schema scale (BCSS) measures participants' self beliefs about themselves and others.

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)

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.

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 questionnaire about negative intrusive imagery in general and specific to the imagery provided in the interview.

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.

Full Information

NCT ID

NCT04635904

First Posted

November 8, 2020

Last Updated

October 25, 2022

Sponsor

Hebrew University of Jerusalem

1. Study Identification

Unique Protocol Identification Number

NCT04635904

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 19, 2021 (Actual)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hebrew University of Jerusalem

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

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

Social Anxiety

Keywords

Social anxiety symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Outcomes assessor that assess mental imagery content (see secondary outcomes) are blind to the condition.

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Imaginal exposure

Arm Type

Experimental

Arm Description

A behavioral intervention in imagery

Arm Title

Imagery rescripting

Arm Type

Experimental

Arm Description

A different behavioral intervention in imagery

Intervention Type

Behavioral

Intervention Name(s)

Imaginal exposure one-session

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Imagery rescriptinf one-session

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline in the Social phobia inventory (SPIN) at the follow-up session

Description

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)

Secondary Outcome Measure Information:

Title

Change from Baseline in the Thought fusion inventory (TFI) at the follow-up session

Description

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)

Title

Change from Baseline in the White Bear Suppresion inventory (WBSI) at the follow-up session

Description

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)

Title

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

Description

Time Frame