Imagery Rescripting and Imaginal Exposure for Anxiety Symptoms

NCT05292807 | Unknown

• 1 other identifier: isf2157/2021
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety; Generalized Anxiety; Obsessive-Compulsive Symptom; Panic

Outcome Measures

Primary Outcomes (5)

• Change from baseline in the Social phobia inventory (SPIN)

  The SPIN is a 17-item validated self-report instrument assessing sum of social phobia symptom intensity over the past week. Possible scores range from 0 (not at all) to 4 (Extremely). Sum scores range is 0-68. Change = 1: (post-intervention score - Baseline Score) 2: (Follow-up score - Baseline Score)

  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)

• Change from baseline in the Anxiety Sensitivity Index - 3 (ASI-3)

  The ASI-3 is an 18-item validated self-report instrument assessing sum of anxiety sensitivity symptom intensity over the past week. Possible scores range from 0 (not at all) to 4 (Very Much). Sum scores range is 0-72. Change = 1: (post-intervention score - Baseline Score) 2: (Follow-up score - Baseline Score)

  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)

• Change from baseline in the Obsessive-Compulsive Inventory Revised (OCI-R)

  The OCI-R is an 18-item validated self-report instrument assessing sum of obsessive-compulsive symptom intensity over the past week (Taylor et al., 2007). Possible scores range from 0 (not at all) to 4 (Extremely). Sum scores range is 0-72. Change = 1: (post-intervention score - Baseline Score) 2: (Follow-up score - Baseline Score)

  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)

• Change from baseline in the Generalized Anxiety Scale-7 (GAD-7)

  The GAD-7 is a 7-item validated self-report instrument assessing sum of generalized anxiety symptom intensity over the past week. Possible scores range from 0 (not at all) to 3 (Almost every day). Sum scores range is 0-21. Change = 1: (post-intervention score - Baseline Score) 2: (Follow-up score - Baseline Score)

  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)

• Change from baseline in The Overall Anxiety Severity and Impairment Scale (OASIS)

  The OASIS is a 5-item validated self-report instrument assessing sum of anxiety related symptoms, distress avoidance and functioning symptom intensity over the past week (Taylor et al., 2007). Possible scores range from 0 to 4. Sum scores range is 0-20. Change = 1: (post-intervention score - Baseline Score) 2: (Follow-up score - Baseline Score)

  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 (19)

• Change from Baseline in the Thought fusion inventory (TFI)

  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)

• Change from Baseline in the Thought Action Fusion scale - Revised (TAFS-R)

  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)

• Change from Baseline to follow-up in the amount of negative and positive/neutral content details of the memory/future imagery

  Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)

• The believability of the negative core-beliefs that the participant link to the negative imagery and memory provided in the WIMI

  Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)

• imaginal Based 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 (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)

Other Outcomes (1)

• Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)

  Baseline only

Study Arms (4)

Imaginal exposure for memories

EXPERIMENTAL

A behavioral intervention in imagery for memories

Behavioral: Imaginal exposure for memories

Imaginal exposure for future events

EXPERIMENTAL

A behavioral intervention in imagery for future events

Behavioral: Imaginal exposure for future events

Imagery rescripting for memories

EXPERIMENTAL

A different behavioral intervention in imagery for memories

Behavioral: Imagery rescripting for memories

Imagery rescripting for future events

EXPERIMENTAL

A different behavioral intervention in imagery for future events

Behavioral: Imagery rescripting for future events

Interventions

Imaginal exposure for memories BEHAVIORAL

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 past distressing anxiety provoking scenario multiple times while honing in on the most negative aspects.

Imaginal exposure for memories

Imaginal exposure for future events BEHAVIORAL

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 scenario multiple times while honing in on the most negative aspects.

Imaginal exposure for future events

Imagery rescripting for memories BEHAVIORAL

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 past 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: First imagining the scenario from a different character perspective that enacts changes in the memories. Second, The will imagine the scenario again from the original perspective along with changes done by the additional character.

Imagery rescripting for memories

Imagery rescripting for future events BEHAVIORAL

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 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: First imagining the scenario from a different character perspective that enacts changes in the memories. Second, The will imagine the scenario again from the original perspective along with changes done by the additional character.

Imagery rescripting for future events

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebrew University of Jerusalem: lead

Study Sites (1)

Hebrew University of Jerusalem

Jerusalem, 9190501, Israel

RECRUITING

Related Publications (18)

• 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.

  PMID: 10827888 BACKGROUND

• 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.

  PMID: 29960125 BACKGROUND

• 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.

  PMID: 26988404 BACKGROUND

• 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.

  PMID: 22315482 BACKGROUND

• 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.

  PMID: 12501574 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 22984633 BACKGROUND

• 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.

  PMID: 32076845 BACKGROUND

• 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.

  PMID: 16929519 BACKGROUND

• 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.

  PMID: 29139125 BACKGROUND

• 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.

  PMID: 21584907 BACKGROUND

• 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.

  PMID: 26033784 BACKGROUND

• 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.

  PMID: 18486238 BACKGROUND

• 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.

  PMID: 35015611 BACKGROUND

• 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.

  PMID: 472086 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 34244982 BACKGROUND

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Jonathan D Huppert, PhD

  Professor in the Hebrew University of Jerusalem psychology department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Snir Barzilay, PhD. student

CONTACT

+972 50 4499 435; snir.barzilay@mail.huji.ac.il

Jonathan D Huppert, PhD

CONTACT

jonathan.huppert@mail.huji.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: April 14, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)