- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04635904
Imagery Rescripting and Imaginal Exposure for Social Anxiety: Mechanisms and Outcomes in an Analog Sample
Imagery Based Interventions for the Treatment of Anxiety Related Disorders: Mechanisms and Optimizing Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Snir Barzilay, Grad student
- Phone Number: +972 50 4499 435
- Email: snir.barzilay@mail.huji.ac.il
Study Contact Backup
- Name: Jonathan D Huppert, PhD
- Email: jonathan.huppert@mail.huji.ac.il
Study Locations
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Jerusalem, Israel, 9190501
- Recruiting
- Hebrew University of Jerusalem
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Contact:
- Jonathan Huppert, PhD
- Phone Number: +97225883376
- Email: jonathan.huppert@mail.huji.ac.il
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Principal Investigator:
- Jonathan D Huppert, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: SPIN scores >= 30 -
Exclusion Criteria:
can't report a negative imagery related to a future social scenario. Attending active psychotherapy sessions.
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Study Plan
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 |
|---|---|
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Experimental: Imaginal exposure
A behavioral intervention in imagery
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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.
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Experimental: Imagery rescripting
A different behavioral intervention in imagery
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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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)
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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)
|
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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)
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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)
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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)
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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.
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Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)
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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)
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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)
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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)
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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)
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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)
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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)
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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)
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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)
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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)
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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)
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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)
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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)
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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)
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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)
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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)
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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.
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Daily, from Baseline to follow-up (a total of 14, 17, or 20 days)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
Time Frame: Baseline only
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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.
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Baseline only
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jonathan D Huppert, PhD, Professor
Publications and helpful links
General Publications
- 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.
- 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. doi: 10.1192/bjp.176.4.379.
- 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. doi: 10.1016/0005-7967(96)00005-8.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- isf2157/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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