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Imagery Rescripting and Imaginal Exposure for Anxiety Symptoms

Primary Purpose

Social Anxiety, Generalized Anxiety, Obsessive-Compulsive Symptom

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Imaginal exposure for memories
Imaginal exposure for future events
Imagery rescripting for memories
Imagery rescripting for future events
Sponsored by
Hebrew University of Jerusalem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hebrew University of JerusalemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Imaginal exposure for memories

Imaginal exposure for future events

Imagery rescripting for memories

Imagery rescripting for future events

Arm Description

A behavioral intervention in imagery for memories

A behavioral intervention in imagery for future events

A different behavioral intervention in imagery for memories

A different behavioral intervention in imagery for future events

Outcomes

Primary Outcome Measures

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)
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)
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)
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)
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)

Secondary Outcome Measures

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)
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)
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.
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.
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
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.
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.
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.

Full Information

First Posted
March 14, 2022
Last Updated
October 25, 2022
Sponsor
Hebrew University of Jerusalem
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1. Study Identification

Unique Protocol Identification Number
NCT05292807
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebrew University of Jerusalem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety, Generalized Anxiety, Obsessive-Compulsive Symptom, Panic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imaginal exposure for memories
Arm Type
Experimental
Arm Description
A behavioral intervention in imagery for memories
Arm Title
Imaginal exposure for future events
Arm Type
Experimental
Arm Description
A behavioral intervention in imagery for future events
Arm Title
Imagery rescripting for memories
Arm Type
Experimental
Arm Description
A different behavioral intervention in imagery for memories
Arm Title
Imagery rescripting for future events
Arm Type
Experimental
Arm Description
A different behavioral intervention in imagery for future events
Intervention Type
Behavioral
Intervention Name(s)
Imaginal exposure for memories
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Imaginal exposure for future events
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Imagery rescripting for memories
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Imagery rescripting for future events
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in the Social phobia inventory (SPIN)
Description
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)
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)
Title
Change from baseline in the Anxiety Sensitivity Index - 3 (ASI-3)
Description
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)
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)
Title
Change from baseline in the Obsessive-Compulsive Inventory Revised (OCI-R)
Description
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)
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)
Title
Change from baseline in the Generalized Anxiety Scale-7 (GAD-7)
Description
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)
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)
Title
Change from baseline in The Overall Anxiety Severity and Impairment Scale (OASIS)
Description
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)
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)
Secondary Outcome Measure Information:
Title
Change from Baseline in the Thought fusion inventory (TFI)
Description
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)
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)
Title
Change from Baseline in the Thought Action Fusion scale - Revised (TAFS-R)
Description
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)
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)
Title
Change from Baseline to follow-up in the amount of negative and positive/neutral content details of the memory/future imagery
Description
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.
Time Frame
Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
Title
The believability of the negative core-beliefs that the participant link to the negative imagery and memory provided in the WIMI
Description
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.
Time Frame
Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
Title
imaginal Based Approach Test (iBAT) that measures the participant's willingness to interact with pre-scripted distressing scenarios in imagination
Description
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
Time Frame
Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
Title
The Brief core schema scale (BCSS)
Description
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)
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)
Title
The Self compassion scale short (SCS)
Description
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)
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)
Title
The impact of future events scale (IFES)
Description
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)
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)
Title
The impact of events scale (IES)
Description
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)
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)
Title
The distress tolerance scale (DTS)
Description
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)
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)
Title
The experiences in close relationship scale short form (ECR-S)
Description
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)
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)
Title
The short form of the metacognitions questionnaire (MCQ-30)
Description
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)
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)
Title
The Beck cognitive insight scale (BCIS)
Description
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)
Time Frame
Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
Title
Locus of control scale (LOC)
Description
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)
Time Frame
Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
Title
Self-Appraisal of Illness Questionnaire (SAIQ)
Description
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)
Time Frame
Will be measured right before the Intervention, right immediately after the intervention, post-intervention ( 7 days after the intervention)
Title
Questionnaire implicit association task (qIAT)
Description
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.
Time Frame
Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
Title
Paced visual serial addition test (PASAT)
Description
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.
Time Frame
Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention)
Title
Daily symptoms
Description
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.
Time Frame
[Time Frame: Daily, from Baseline to post-intervention (a total of 14, or 21 days)]
Title
Daily mechanisms
Description
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.
Time Frame
[Time Frame: Daily, from Baseline to post-intervention (a total of 14, or 21 days)]
Other Pre-specified Outcome Measures:
Title
Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
Description
This interview is based on DSM-5 (Diagnostic and Statistical Manual of Mental Disorders fifth edition) diagnostic criteria. It will allow us to detect the presence of social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder and/or panic disorder before the start of the intervention. This interview will be used to exclude participants based on suicidality, psychosis, post-traumatic stress disorder, acute-stress disorder and substance abuse disorder.
Time Frame
Baseline only

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Snir Barzilay, PhD. student
Phone
+972 50 4499 435
Email
snir.barzilay@mail.huji.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan D Huppert, PhD
Email
jonathan.huppert@mail.huji.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan D Huppert, PhD
Organizational Affiliation
Professor in the Hebrew University of Jerusalem psychology department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebrew University of Jerusalem
City
Jerusalem
ZIP/Postal Code
9190501
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Huppert, PhD
Phone
+97225883376
Email
jonathan.huppert@mail.huji.ac.il
First Name & Middle Initial & Last Name & Degree
Jonathan D Huppert, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
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Imagery Rescripting and Imaginal Exposure for Anxiety Symptoms

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