Social AnxietyNCT05292807
Imagery Rescripting and Imaginal Exposure for Anxiety Symptoms
A study testing Imaginal exposure for memories, Imaginal exposure for future events and Imagery rescripting for memories in people with Social Anxiety and Generalized Anxiety, run by Hebrew University of Jerusalem at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety, Generalized Anxiety, Obsessive-Compulsive Symptom
- What is being tested?
- Imaginal exposure for memories, Imaginal exposure for future events and Imagery rescripting for memories
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Apr 2022to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Jonathan D Huppert, PhD contact
Israel1 site, 1 recruiting
- Recruiting
Hebrew University of Jerusalem
Jerusalem, 9190501
Jonathan Huppert, PhD, +97225883376, jonathan.huppert@mail.huji.ac.il
Jonathan D Huppert, PhD
About this study
Official title: Imagery Rescripting and Imaginal Exposure for Anxiety Symptoms: Mechanisms and Outcomes in a Large Analog Sample
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.
Read the 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.
- Being tested
- Imaginal exposure for memories, Imaginal exposure for future events, Imagery rescripting for memories, Imagery rescripting for future events
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaginal exposure for memoriesBehavioural
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 future eventsBehavioural
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.
Imagery rescripting for memoriesBehavioural
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 future eventsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Imaginal exposure for memories | Experimental | A behavioral intervention in imagery for memories Receives: Behavioral: Imaginal exposure for memories |
| Imaginal exposure for future events | Experimental | A behavioral intervention in imagery for future events Receives: Behavioral: Imaginal exposure for future events |
| Imagery rescripting for memories | Experimental | A different behavioral intervention in imagery for memories Receives: Behavioral: Imagery rescripting for memories |
| Imagery rescripting for future events | Experimental | A different behavioral intervention in imagery for future events Receives: Behavioral: Imagery rescripting for future events |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
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.
Average score (0- 100) Change = 1: (post-intervention score - Baseline Score) 2: (Follow-up score - Baseline Score)
Measured: 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)
The TAFS-R is a validated 19 item self-reported instrument assessing belief in statement that describe the irrational assumption that just because a "bad" thought presents itself to the mind, then it is undeniably followed or accompanied by a specific "bad" action. Possible scores range from 0 (Do not agree) to 4 (Agree alot).
Sum score (0- 76) Change = 1: (post-intervention score - Baseline Score) 2: (Follow-up score - Baseline Score)
Measured: 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
The Waterloo Image and Memories Interview (WIMI) is a validated structured interview for assessing content of imagery and memories. valence of the details will be scored using a trained coder.
change = post-intervention - Baseline Score. The participant provides descriptions of a negative imagery and memory related to his primary symptoms dimension.
Measured: 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
The Waterloo Image and Memories Interview (WIMI) is a validated structured interview for assessing content of core beliefs related to the future imagery and memory.
Believability will be given by the participant for each identified core-belief on a scale of 0 (Do not believe it at all) to 100 (Completely Believe it).
change = post-intervention - Baseline Score.
Measured: 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
The iBAT is currently being developed in our lab. The more levels the participants pass (listen to imaginal scenario in full without pressing "skip") the higher the score he receive (from 0 to 10)
There are two versions in the task, each with different 10 scenarios. The versions will be counterbalanced across participants.
Recruitment is completed for the first sample and pre-registration is available at the open science framework website:
change = post-intervention - Baseline Score.
https://osf.io/bp42h/?view_only=5211617cedf94f71a4daa746e98d924a
Measured: Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
The Brief core schema scale (BCSS)
the BCSS measures participants' self-beliefs about themselves and others. It 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)
Two sum scores: self (0- 36), other (0-36) Change = 1: (post-intervention score - Baseline Score) 2: (Follow-up score - Baseline Score)
Measured: 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)
The Self compassion scale short (SCS)
The SCS is a validated self-report measure, that measures participants' tendency to react to one own suffering and misfortune with self-compassion. It has 12 items with scores ranging from 1 (Almost never) to 5 (Almost always).
Sum score (12- 60) Change = 1: (post-intervention score - Baseline Score) 2: (Follow-up score - Baseline Score)
Measured: 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)
The impact of future events scale (IFES)
The IFES is a validated self-report measure, that measures participants' symptoms in reaction to negative future events. It has 24 items with scores ranging from 0 (Not at all) to 4 (A lot).
Sum score (0- 96) Change = 1: (post-intervention score - Baseline Score) 2: (Follow-up score - Baseline Score)
Measured: 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)
The impact of events scale (IES)
The IES is a validated self-report measure, that measures participants' symptoms in reaction to negative past events. It has 22 items with scores ranging from 0 (Not at all) to 4 (A lot).
Sum score (0- 88) Change = 1: (post-intervention score - Baseline Score) 2: (Follow-up score - Baseline Score)
Measured: 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)
The distress tolerance scale (DTS)
The DTS is a validated self-report measure, that measures participants' ability to tolerate distress. It has 15 items with scores ranging from 1 (Completely agree) to 5 (Completely do not agree).
Sum score (15- 75) Change = 1: (post-intervention score - Baseline Score) 2: (Follow-up score - Baseline Score)
Measured: 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)
The experiences in close relationship scale short form (ECR-S)
The ECR-S is a validated self-report measure, that measures participants' behavior in close relationships and maps these behaviors on dimensions of anxious attachment and avoidant attachment. It has 12 items with scores ranging from 1 (Strongly Disagree) to 7 (Strongly Agree).
Two average scores: anxious attachment (1-7), other (1-7) Change = 1: (post-intervention score - Baseline Score) 2: (Follow-up score - Baseline Score)
Measured: 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)
The short form of the metacognitions questionnaire (MCQ-30)
The MCQ-30 is a validated self-report measure, that measures participants' beliefs about their cognitions. It has 30 items with scores ranging from 1 (Do not agree) to 4 (Agree a lot).
Sum score (30- 120) Change = 1: (post-intervention score - Baseline Score) 2: (Follow-up score - Baseline Score)
Measured: 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)
The Beck cognitive insight scale (BCIS)
The BCIS is a validated self-report measure, that measures participants' cognitive insight about their symptoms. It has 15 items with scores ranging from 0 (Do not agree) to 3 (Completely Agree).
Sum score (0- 45) Change = 1: (post-intervention score - Baseline Score)
Measured: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
Locus of control scale (LOC)
The Locus of control scale measures participants feeling of control over their problems in life. It has 5 items with scores ranging from 1 (Completely not agree) to 5 (Completely Agree).
Sum score (5- 25) Change = 1: (post-intervention score - Baseline Score)
Measured: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
Self-Appraisal of Illness Questionnaire (SAIQ)
The SAIQ assess attitudes toward mental illness among persons receiving psychiatric treatment.
There will be 8 items from that questionnaire:
0 (Not at all) to 3 (A great deal) In general, how much do you tend to worry? How much do you worry about your condition? How much do you worry about losing friends because of your condition? How much do you worry about being unable to work because of your condition?
0 (Strongly agree) to 3 (Strongly Disagree) Do you believe the current treatment to be necessary? I think my condition requires psychiatric treatment I think my condition will go away by itself? If I were to discontinue treatment today I would do fine
Change = 1: (post-intervention score - before intervention) 2: (after intervention - before intervention)
Measured: Will be measured right before the Intervention, right immediately after the intervention, post-intervention ( 7 days after the intervention)
Questionnaire implicit association task (qIAT)
In this task, participant will classify sentences into two categories (TRUE of FALSE). Sentences are statement taken from the brief core schema scale describing self-beliefs in a positive or negative way. Participants in one block would have to respond TRUE to the positive statements and FALSE to the negative statements. In the second block, the instruction will be reversed, and participants will respond TRUE to the negative statements and FALSE to the positive statements.
For each participant a d score will be calculated based on the algorithm in Greenwald, Nosek and Banaji (2003) paper.
change = post-intervention - Baseline Score.
Measured: Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
Paced visual serial addition test (PASAT)
The task requires participants to perform serial additions using the two previously displayed single digits (1-9) in a long running series of digits. They need to add the digits by pressing numbers presented on a circle on screen (2-18). The latency between digits begins at 3s in the initial 3 min block allowing participants to acclimatize to the task itself. The second block is 5-min long with a shorter display latency of 2 s between digits. The third block has a latency of 1s and can last for a maximum of 10 min; however, participants are instructed during the rest period that due to the difficulty they are allowed to end this block at any time by pressing a designated key on the terminals' keyboard. Duration of the third block provides a time measure for resistance to psychological stress
change = post-intervention - Baseline Score.
Measured: Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
Daily symptoms
The first 3 OASIS (see above) items pertaining to frequency, severity and avoidance of anxiety.
Two of the following symptom focus area (based on the results from the DIAMOND interview in the baseline assessment):
social anxiety (1-7): I was afraid I will say or do the wrong things. I was afraid what other people would think of me. I was afraid others would not accept me. Obsessions and compulsions: three items from the OCI-R that participant scored the highest at. (0-4) Anxiety sensitivity: (0-4) I was anxious that a panic attack would occur. I was anxious I would not be able to handle the panic attack. I was anxious something horrible would happen if a panic attack would occur. I tried to avoid experiencing a panic attack. Generalized anxiety: (0-4) I couldn't worrying or controlling my worry. I was so restless I had trouble sitting down without moving. I was way too worried about different things.
Measured: [Time Frame: Daily, from Baseline to post-intervention (a total of 14, or 21 days)]
Daily mechanisms
Participants will fill out 9 items pertaining to specific symptoms and mechanisms (Not at all 0 to 100 Very much VAS):
I believed that if I thought or imagined an unpleasant event it causes it more likely to happen.
I believed that if I thought or imagined I would behave in a negative way it is more likely that I would actually behave this way I believed my thoughts become reality, if I think something it will come true I felt vulnerable I felt weak I tried being understanding and patient towards the aspects in my personality I do not love I try to remind myself that feelings of inadequacy are shared by most people I couldn't handle feelings of stress or distress I did everything to stop feeling stress or distress.
Measured: [Time Frame: Daily, from Baseline to post-intervention (a total of 14, or 21 days)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start14 Apr 2022
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebrew University of Jerusalem
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan D. Huppert, Hebrew University of Jerusalem
- Investigators
- Jonathan D Huppert, PhD, Principal investigator, Professor in the Hebrew University of Jerusalem psychology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292807
- Sponsor's protocol ID
- isf2157/2021
- Status last verified
- Oct 2022
- First submitted
- 14 Mar 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10827888Moscovitch 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.
PubMed 29960125Tolin 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.
PubMed 26988404Meyer 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.
PubMed 22315482Foa 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.
PubMed 12501574Spitzer 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.
PubMed 16717171Deeprose 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.
PubMed 22984633Strachan 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.
PubMed 32076845van 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.
PubMed 16929519Garner 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.
PubMed 29139125Raes 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.
PubMed 21584907Pedersen 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.
PubMed 26033784Campbell-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.
PubMed 18486238Faustino 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.
PubMed 35015611Horowitz 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.
PubMed 472086
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imagery Rescripting and Imaginal Exposure for Anxiety Symptoms: Mechanisms and Outcomes in a Large Analog Sample
- ClinicalTrials.gov ID
- NCT05292807
- Acronym / sponsor ID
- isf2157/2021
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Hebrew University of JerusalemUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 23 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Imaginal exposure for memories | Experimental | Behavioral: Imaginal exposure for memoriesA behavioral intervention in imagery for memories |
| Imaginal exposure for future events | Experimental | Behavioral: Imaginal exposure for future eventsA behavioral intervention in imagery for future events |
| Imagery rescripting for memories | Experimental | Behavioral: Imagery rescripting for memoriesA different behavioral intervention in imagery for memories |
| Imagery rescripting for future events | Experimental | Behavioral: Imagery rescripting for future eventsA different behavioral intervention in imagery for future events |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 .
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaginal exposure for memoriesParticipants 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. | Behavioural | Imaginal exposure for memories |
| Imaginal exposure for future eventsParticipants 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. | Behavioural | Imaginal exposure for future events |
| Imagery rescripting for memoriesParticipants 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. | Behavioural | Imagery rescripting for memories |
| Imagery rescripting for future eventsParticipants 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. | Behavioural | Imagery rescripting for future events |
Primary outcome
Change from baseline in the Social phobia inventory (SPIN)
Time frame: 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)
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)
Change from baseline in the Anxiety Sensitivity Index - 3 (ASI-3)
Time frame: 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)
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)
Change from baseline in the Obsessive-Compulsive Inventory Revised (OCI-R)
Time frame: 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)
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)
Change from baseline in the Generalized Anxiety Scale-7 (GAD-7)
Time frame: 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)
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)
Change from baseline in The Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: 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)
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)
19 secondary outcomes
Change from Baseline in the Thought fusion inventory (TFI)
Time frame: 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)
Time frame: 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: 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: 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: Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
The Brief core schema scale (BCSS)
Time frame: 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)
The Self compassion scale short (SCS)
Time frame: 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)
The impact of future events scale (IFES)
Time frame: 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)
The impact of events scale (IES)
Time frame: 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)
The distress tolerance scale (DTS)
Time frame: 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)
The experiences in close relationship scale short form (ECR-S)
Time frame: 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)
The short form of the metacognitions questionnaire (MCQ-30)
Time frame: 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)
The Beck cognitive insight scale (BCIS)
Time frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
Locus of control scale (LOC)
Time frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
Self-Appraisal of Illness Questionnaire (SAIQ)
Time frame: Will be measured right before the Intervention, right immediately after the intervention, post-intervention ( 7 days after the intervention)
Questionnaire implicit association task (qIAT)
Time frame: Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
Paced visual serial addition test (PASAT)
Time frame: Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
Daily symptoms
Time frame: [Time Frame: Daily, from Baseline to post-intervention (a total of 14, or 21 days)]
Daily mechanisms
Time frame: [Time Frame: Daily, from Baseline to post-intervention (a total of 14, or 21 days)]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Background: PubMed 10827888Connor 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.
- Background: PubMed 29960125Moscovitch 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.
- Background: PubMed 26988404Tolin 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.
- Background: PubMed 22315482Meyer 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.
- Background: PubMed 12501574Foa 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.
- Background: PubMed 16717171Spitzer 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.
- Background: PubMed 22984633Deeprose 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.
- Background: PubMed 32076845Strachan 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.
- Background: PubMed 16929519van 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.
- Background: PubMed 29139125Garner 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.
- Background: PubMed 21584907Raes 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.
- Background: PubMed 26033784Pedersen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan D Huppert, PhD contact
Jonathan D Huppert, PhD principal investigator
Professor in the Hebrew University of Jerusalem psychology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaginal exposure for memories, Imaginal exposure for future events and Imagery rescripting for memories in people with Social Anxiety and Generalized Anxiety, run by Hebrew University of Jerusalem at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Snir Barzilay, PhD. student (+972 50 4499 435, snir.barzilay@mail.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Social phobia inventory (SPIN) (time frame: 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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05292807, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.