Clinical trial NCT04635904: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Social Anxiety
Keywords: Social anxiety symptoms
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria: SPIN scores \>= 30 -

Exclusion Criteria:

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

-

Primary outcomes:
measure: Change from baseline in the Social phobia inventory (SPIN) at the follow-up session
timeFrame: 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 outcomes:
measure: Change from Baseline in the Thought fusion inventory (TFI) at the follow-up session
timeFrame: 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)
measure: Change from Baseline in the White Bear Suppresion inventory (WBSI) at the follow-up session
timeFrame: 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)
measure: 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
timeFrame: Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)
measure: 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).
timeFrame: Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)
measure: Change from Baseline to follow-up in negativity of the core-beliefs that the participant link to the negative imagery provided in the WIMI.
timeFrame: Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)
measure: imaginal Behavioral Approach Test (iBAT) that measures the participant's willingness to interact with pre-scripted distressing scenarios in imagination
timeFrame: Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)
measure: Sentence Completion Task (SCT). Measures participants automatic interpretation bias while being presented with 10 ambiguous social scenarios.
timeFrame: Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)
measure: The Patient's Experience of Attunement and Responsiveness Scale (PEAR) measures participants' feelings of acceptance by the intervention and interview providers
timeFrame: 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)
measure: The Brief core schema scale (BCSS) measures participants' self beliefs about themselves and others.
timeFrame: 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)
measure: 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.
timeFrame: Daily, from Baseline to follow-up (a total of 14, 17, or 20 days)
measure: Daily questionnaire about negative intrusive imagery in general and specific to the imagery provided in the interview.
timeFrame: Daily, from Baseline to follow-up (a total of 14, 17, or 20 days)
Other outcomes:
measure: Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
timeFrame: Baseline only
Locations:
city: Jerusalem
country: Israel
facility: Hebrew University of Jerusalem
Study officials:
affiliation: Professor
name: Jonathan D Huppert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1192/bjp.176.4.379.
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. doi: 10.1016/0005-7967(96)00005-8.
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.
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.
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.