Clinical trial NCT05292807: Imagery Rescripting and Imaginal Exposure for Anxiety Symptoms
Official title: Imagery Rescripting and Imaginal Exposure for Anxiety Symptoms: Mechanisms and Outcomes in a Large Analog Sample
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Social Anxiety
Generalized Anxiety
Obsessive-Compulsive Symptom
Panic
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 460
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 460 participants who self-report high symptoms of anxiety. Participants will be randomly assigned to one of 4 groups: one analog intervention of Imagery Rescripting (IR) for memories, an analog intervention of IR for future events, and analog intervention of Imaginal Exposure (IE) for memories and an analog intervention of IE for future events. We will examine the efficacy and mechanisms behind each intervention.

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 one of four conditions (Imagery rescripting past; Imagery rescripting future; Imaginal exposure past; Imaginal exposure future) at a 1:1:1:1 ratio (n = 115 per group). Participant will be assigned using a variance minimization method that controls for between group variance in continuous and categorical variables- SPIN, ASI-3, OCI-R, GAD-7 and gender with a completely random assignment p random = .2 (for algorithm see Sella et al., 2018). Participants will attend three \~1.5 hour online ZOOM sessions (baseline-assessment and measurement, intervention, post assessment and measurement and follow-up measurement).

In this multiple baseline study, participant will enter the intervention phase either 7 or 14 days after the baseline stage.

Assessors will be blind to the treatment condition.

Eligibility criteria: Inclusion Criteria:

We will recruit participants based on attainment of SPIN score \>= 24 and/or ASI-3 scores \>=23 and/or OCI-R subscale scores (not including hoarding subscale) \>=6 and/or GAD-7 scores \>= 9 .

Exclusion Criteria:

Diagnosis of psychosis, active suicidality, post-traumatic stress disorder, acute stress disorder. Can't report a negative imagery related to a future social scenario. Attending active psychotherapy sessions. Started/stopped taking psychotherapeutic medications in the last 3 months.

Primary outcomes:
measure: Change from baseline in the Social phobia inventory (SPIN)
timeFrame: Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention ( 7 days after the intervention) and Follow-up (28 days after the intervention)
measure: Change from baseline in the Anxiety Sensitivity Index - 3 (ASI-3)
timeFrame: Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention (7 days after the intervention) and Follow-up (28 days after the intervention)
measure: Change from baseline in the Obsessive-Compulsive Inventory Revised (OCI-R)
timeFrame: Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention (7 days after the intervention) and Follow-up (28 days after the intervention)
measure: Change from baseline in the Generalized Anxiety Scale-7 (GAD-7)
timeFrame: Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention (7 days after the intervention) and Follow-up (28 days after the intervention)
measure: Change from baseline in The Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention (7 days after the intervention) and Follow-up (28 days after the intervention)
Secondary outcomes:
measure: Change from Baseline in the Thought fusion inventory (TFI)
timeFrame: Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention ( 7 days after the intervention) and Follow-up (28 days after the intervention)
measure: Change from Baseline in the Thought Action Fusion scale - Revised (TAFS-R)
timeFrame: Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention (7 days after the intervention) and Follow-up (28 days after the intervention)
measure: Change from Baseline to follow-up in the amount of negative and positive/neutral content details of the memory/future imagery
timeFrame: Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
measure: The believability of the negative core-beliefs that the participant link to the negative imagery and memory provided in the WIMI
timeFrame: Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
measure: imaginal Based Approach Test (iBAT) that measures the participant's willingness to interact with pre-scripted distressing scenarios in imagination
timeFrame: Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
measure: The Brief core schema scale (BCSS)
timeFrame: Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention (7 days after the intervention) and Follow-up (28 days after the intervention)
measure: The Self compassion scale short (SCS)
timeFrame: Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention (7 days after the intervention) and Follow-up (28 days after the intervention)
measure: The impact of future events scale (IFES)
timeFrame: Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention ( 7 days after the intervention) and Follow-up (28 days after the intervention)
measure: The impact of events scale (IES)
timeFrame: Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention ( 7 days after the intervention) and Follow-up (28 days after the intervention)
measure: The distress tolerance scale (DTS)
timeFrame: Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention ( 7 days after the intervention) and Follow-up (28 days after the intervention)
measure: The experiences in close relationship scale short form (ECR-S)
timeFrame: Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention ( 7 days after the intervention) and Follow-up (28 days after the intervention)
measure: The short form of the metacognitions questionnaire (MCQ-30)
timeFrame: Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention ( 7 days after the intervention) and Follow-up (28 days after the intervention)
measure: The Beck cognitive insight scale (BCIS)
timeFrame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
measure: Locus of control scale (LOC)
timeFrame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
measure: Self-Appraisal of Illness Questionnaire (SAIQ)
timeFrame: Will be measured right before the Intervention, right immediately after the intervention, post-intervention ( 7 days after the intervention)
measure: Questionnaire implicit association task (qIAT)
timeFrame: Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
measure: Paced visual serial addition test (PASAT)
timeFrame: Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
measure: Daily symptoms
timeFrame: [Time Frame: Daily, from Baseline to post-intervention (a total of 14, or 21 days)]
measure: Daily mechanisms
timeFrame: [Time Frame: Daily, from Baseline to post-intervention (a total of 14, or 21 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 in the Hebrew University of Jerusalem psychology department
name: Jonathan D Huppert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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.
citation: Meyer JF, Brown TA. Psychometric evaluation of the thought-action fusion scale in a large clinical sample. Assessment. 2013 Dec;20(6):764-75. doi: 10.1177/1073191112436670. Epub 2012 Feb 6.
citation: Foa EB, Huppert JD, Leiberg S, Langner R, Kichic R, Hajcak G, Salkovskis PM. The Obsessive-Compulsive Inventory: development and validation of a short version. Psychol Assess. 2002 Dec;14(4):485-96.
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
citation: Deeprose C, Malik A, Holmes EA. Measuring Intrusive Prospective Imagery using the Impact of Future Events Scale (IFES): Psychometric properties and relation to risk for Bipolar Disorder. Int J Cogn Ther. 2011 Jun;4(2):187-196. doi: 10.1521/ijct.2011.4.2.187.
citation: Strachan LP, Hyett MP, McEvoy PM. Imagery Rescripting for Anxiety Disorders and Obsessive-Compulsive Disorder: Recent Advances and Future Directions. Curr Psychiatry Rep. 2020 Feb 19;22(4):17. doi: 10.1007/s11920-020-1139-4.
citation: van Minnen A, Foa EB. The effect of imaginal exposure length on outcome of treatment for PTSD. J Trauma Stress. 2006 Aug;19(4):427-38. doi: 10.1002/jts.20146.
citation: Garner LE, Van Kirk N, Tifft ED, Krompinger JW, Mathes BM, Fraire M, Falkenstein MJ, Brennan BP, Crosby JM, Elias JA. Validation of the distress tolerance scale-short form in obsessive compulsive disorder. J Clin Psychol. 2018 Jun;74(6):916-925. doi: 10.1002/jclp.22554. Epub 2017 Nov 15.
citation: Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
citation: Pedersen G, Eikenaes I, Urnes O, Skulberg GM, Wilberg T. Experiences in Close Relationships - Psychometric properties among patients with personality disorders. Personal Ment Health. 2015 Aug;9(3):208-19. doi: 10.1002/pmh.1298. Epub 2015 Jun 1.
citation: Campbell-Sills L, Norman SB, Craske MG, Sullivan G, Lang AJ, Chavira DA, Bystritsky A, Sherbourne C, Roy-Byrne P, Stein MB. Validation of a brief measure of anxiety-related severity and impairment: the Overall Anxiety Severity and Impairment Scale (OASIS). J Affect Disord. 2009 Jan;112(1-3):92-101. doi: 10.1016/j.jad.2008.03.014. Epub 2008 May 16.
citation: Faustino B. Maladaptive and Adaptive Cognitions About the Self and Others: Confirmatory Factor Analysis of the Brief Core Schemas Scales. Psychol Rep. 2023 Jun;126(3):1445-1460. doi: 10.1177/00332941211063602. Epub 2022 Jan 11.
citation: Horowitz M, Wilner N, Alvarez W. Impact of Event Scale: a measure of subjective stress. Psychosom Med. 1979 May;41(3):209-18. doi: 10.1097/00006842-197905000-00004.
citation: Greenwald AG, Nosek BA, Banaji MR. Understanding and using the implicit association test: I. An improved scoring algorithm. J Pers Soc Psychol. 2003 Aug;85(2):197-216. doi: 10.1037/0022-3514.85.2.197.
citation: Ozakbas S, Cinar BP, Gurkan MA, Ozturk O, Oz D, Kursun BB. Paced auditory serial addition test: National normative data. Clin Neurol Neurosurg. 2016 Jan;140:97-9. doi: 10.1016/j.clineuro.2015.11.014. Epub 2015 Nov 24.
citation: Sella F, Raz G, Cohen Kadosh R. When randomisation is not good enough: Matching groups in intervention studies. Psychon Bull Rev. 2021 Dec;28(6):2085-2093. doi: 10.3758/s13423-021-01970-5. Epub 2021 Jul 9.