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

Social Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04635904
• Other study ID #: isf2157/2020
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: August 2023

Study information

• Verified date: October 2022
• Source: Hebrew University of Jerusalem
• Contact: Snir Barzilay, Grad student
• Phone: +972 50 4499 435
• Email: snir.barzilay[@]mail.huji.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria: SPIN scores >= 30 - Exclusion Criteria: can't report a negative imagery related to a future social scenario. Attending active psychotherapy sessions. -

Related Conditions & MeSH terms

• Anxiety Disorders
• Social Anxiety

Intervention

Behavioral:
• Imaginal exposure one-session
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.
• Imagery rescriptinf one-session
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.

Locations

Country	Name	City	State
Israel	Hebrew University of Jerusalem	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hebrew University of Jerusalem

Country where clinical trial is conducted

Israel, 

References & Publications (6)

Aderka IM, Pollack MH, Simon NM, Smits JA, Van Ameringen M, Stein MB, Hofmann SG. Development of a brief version of the Social Phobia Inventory using item response theory: the Mini-SPIN-R. Behav Ther. 2013 Dec;44(4):651-61. doi: 10.1016/j.beth.2013.04.011. Epub 2013 May 3. — View Citation

Connor KM, Davidson JR, Churchill LE, Sherwood A, Foa E, Weisler RH. Psychometric properties of the Social Phobia Inventory (SPIN). New self-rating scale. Br J Psychiatry. 2000 Apr;176:379-86. — View Citation

Moscovitch DA, Vidovic V, Lenton-Brym AP, Dupasquier JR, Barber KC, Hudd T, Zabara N, Romano M. Autobiographical memory retrieval and appraisal in social anxiety disorder. Behav Res Ther. 2018 Aug;107:106-116. doi: 10.1016/j.brat.2018.06.008. Epub 2018 Jun 22. — View Citation

Muris P, Merckelbach H, Horselenberg R. Individual differences in thought suppression. The White Bear Suppression Inventory: factor structure, reliability, validity and correlates. Behav Res Ther. 1996 May-Jun;34(5-6):501-13. — View Citation

Romano M, Moscovitch DA, Saini P, Huppert JD. The effects of positive interpretation bias on cognitive reappraisal and social performance: Implications for social anxiety disorder. Behav Res Ther. 2020 Aug;131:103651. doi: 10.1016/j.brat.2020.103651. Epub 2020 May 22. — View Citation

Tolin DF, Gilliam C, Wootton BM, Bowe W, Bragdon LB, Davis E, Hannan SE, Steinman SA, Worden B, Hallion LS. Psychometric Properties of a Structured Diagnostic Interview for DSM-5 Anxiety, Mood, and Obsessive-Compulsive and Related Disorders. Assessment. 2018 Jan;25(1):3-13. doi: 10.1177/1073191116638410. Epub 2016 Mar 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)	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
Primary	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)	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	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.	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	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.	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	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.	Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)
Secondary	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.	Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)
Secondary	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.	Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)
Secondary	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	Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)
Secondary	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)	Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)
Secondary	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)	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	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)	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	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, from Baseline to follow-up (a total of 14, 17, or 20 days)
Secondary	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.	Daily, from Baseline to follow-up (a total of 14, 17, or 20 days)