Feasibility Study of the Self-Care Immediate Stabilization Procedure (ISP) ® After a Traumatic Experience

Post-traumatic Stress Disorder Clinical Trial

Official title:

Self-Care Immediate Stabilization Procedure (ISP) ® After a Traumatic Experience - A Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06277973
• Other study ID #: 0007551-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Tel Aviv University
• Contact: Oren Asman, LLD
• Phone: 0097236408488
• Email: asman[@]tauex.tau.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to assess the feasibility of an online intervention platform based on the Immediate Stabilization Procedure (ISP®). This intervention targets early trauma reactions, aiming to reduce the risk of future PTSD.

Description:

The primary objective of this study is to assess the effectiveness and feasibility of an immediate stabilization procedure adapted for online self-usage. This procedure relies on the Eye Movement Desensitization and Reprocessing (EMDR) treatment, a well-known approach for post-traumatic responses. It involves bilateral stimulation of the brain's hemispheres through tapping on the body (i.e., the 'Butterfly Hug') and positive therapist statements during the tapping process. Key advantages of this protocol include: 1) prevents long-term post-traumatic symptoms; 2) short intervention - takes 5-20 minutes on average; 3) simple procedure that does not require recalling traumatic memories; 4) could be administered by non-mental health experts. The ISP® protocol was found effective and safe in Israel (face-to-face) and the Ukraine (remote). In addition, online variations of the protocol for self-usage have been utilized globally. The on-going state of war emphasizes the critical need for immediate emotional support. A collaborative group involving researchers, mental health clinicians, and software engineers adapted the ISP® protocol for online self-usage. The current study aims to evaluate the efficiency of this intervention.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Hebrew speakers

2. Age 18 years or older

3. Have been in Israel since October 7th 2023 (the start of the war)

4. Were exposed to traumatic events during the war (Alarms, participated in battles, were attacked by terrorists, etcetera)

5. Access to PC/smartphone

6. Basic technological skills, ability to use the internet and email.

Exclusion Criteria:

1. Diagnosed with psychotic conditions.

2. Diagnosed with PTSD or complex PTSD.

3. Diagnosed with alcohol use disorder or drug abuse disorder.

4. Suicidal ideation

5. Treated with medication, psychotherapy, or any other mental treatment About 10 randomly selected subjects will perform the intervention while recorded via zoom in the presence of a research assistant. This will allow us to assess the way subjects utilize this intervention.

Related Conditions & MeSH terms

• Acute Stress Disorder
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Stress Disorders, Traumatic, Acute

Intervention

Behavioral:
• Eye Movement Desensitization and Reprocessing (EMDR)
The intervention is based on EMDR therapy for PTSD treatment. Participants will answer demographic questions, choose a primary distress source and watch a therapist-guided video (male or female, based on participant choice) that will instruct them through the 'Butterfly Hug' method (tapping alternately on both sides of the body) while hearing positive statements from the therapists on the chosen distress source. Before and after each video participants will rate their distress level on a scale between 0 and 10 and they can view up to 8 videos per session. The system will monitor distress levels, and if it detects a sustained deterioration, it will end the intervention. At the end of the intervention, participants will be given information about possible reactions to it and how to deal with them, they will be encouraged to use the technique whenever necessary, and they will be informed of relevant support lines that they can contact if needed.

Locations

Country	Name	City	State
Israel	Tel Aviv University	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

References & Publications (12)

Beatty, S., Moore-Felton, M.S., Zaporozhets, O. et al. Effectiveness of Immediate Stabilization Procedure (ISP®) Associated with Wartime Events. Int J Adv Counselling (2023). https://doi.org/10.1007/s10447-023-09531-2

Bernstein EM, Putnam FW. Development, reliability, and validity of a dissociation scale. J Nerv Ment Dis. 1986 Dec;174(12):727-35. doi: 10.1097/00005053-198612000-00004. — View Citation

Brunet A, Weiss DS, Metzler TJ, Best SR, Neylan TC, Rogers C, Fagan J, Marmar CR. The Peritraumatic Distress Inventory: a proposed measure of PTSD criterion A2. Am J Psychiatry. 2001 Sep;158(9):1480-5. doi: 10.1176/appi.ajp.158.9.1480. — View Citation

Cardena E, Koopman C, Classen C, Waelde LC, Spiegel D. Psychometric properties of the Stanford Acute Stress Reaction Questionnaire (SASRQ): a valid and reliable measure of acute stress. J Trauma Stress. 2000 Oct;13(4):719-34. doi: 10.1023/A:1007822603186. — View Citation

Derogatis LR. BSI 18, Brief Symptom Inventory 18: Administration, scoring and Procedure Manual. Minneapolis, MN: NCS Pearson, Incorporated; 2001.

Fuse T, Forsyth JP, Marx B, Gallup GG, Weaver S. Factor structure of the Tonic Immobility Scale in female sexual assault survivors: an exploratory and Confirmatory Factor Analysis. J Anxiety Disord. 2007;21(3):265-83. doi: 10.1016/j.janxdis.2006.05.004. Epub 2006 Jul 18. — View Citation

Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment, 26(1), 41-54. https://doi.org/10.1023/B:JOBA.0000007455.08539.94

Kilpatrick DG, Resnick HS, Milanak ME, Miller MW, Keyes KM, Friedman MJ. National estimates of exposure to traumatic events and PTSD prevalence using DSM-IV and DSM-5 criteria. J Trauma Stress. 2013 Oct;26(5):537-47. doi: 10.1002/jts.21848. — View Citation

Marmar, C. R., Weiss, D. S., & Metzler, T. J. (1997). The Peritraumatic Dissociative Experiences Questionnaire. In J. P. Wilson & T. M. Keane (Eds.), Assessing psychological trauma and PTSD (pp. 412-428). The Guilford Press.

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. — View Citation

Weathers, F. W., Litz, B. T., Keane, T. M., Palmieri, P. A., Marx, B. P., & Schnurr, P. P. (2013). The ptsd checklist for dsm-5 (pcl-5). Scale available from the National Center for PTSD at www. ptsd. va. gov, 10(4), 206

Zvolensky MJ, Garey L, Fergus TA, Gallagher MW, Viana AG, Shepherd JM, Mayorga NA, Kelley LP, Griggs JO, Schmidt NB. Refinement of anxiety sensitivity measurement: The Short Scale Anxiety Sensitivity Index (SSASI). Psychiatry Res. 2018 Nov;269:549-557. doi: 10.1016/j.psychres.2018.08.115. Epub 2018 Aug 29. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCL-5 (Posttraumatic Stress Disorder Checklist)	The PCL-5 is a self-report 20-item questionnaire that conforms with the DSM-5 symptom criteria for PTSD. Each item is rated on a scale of 0-4 and reflects a symptom of PTSD and the total scores range from 0 to 80. The severity scores for DSM-5 symptom clusters can be obtained by adding the scores for the items within each cluster, i.e., cluster B (items 1-5), cluster C (items 6-7), cluster D (items 8-14), and cluster E (items 15-20).	Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107
Primary	GAD-7 (General Anxiety Disorder-7)	A widely used self-report measure for assessing symptoms of generalized anxiety disorder is the Generalized Anxiety Disorder-7 (GAD-7). Moreover, it can also be used to measure anxiety in the general population. This questionnaire contains seven items, and the final questionnaire result is the sum of the items. The total score ranges from 0 to 21, with each item's scale ranging from 0 to 3.; 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: Severe anxiety	Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107
Primary	SSASI (The Short Scale Anxiety Sensitivity Index)	The Short Scale Anxiety Sensitivity Index (SSASI) is a shorter version of the Anxiety Sensitivity Index-3 (ASI-3).; This 5-items scale measures an individual's fear of the negative consequences associated with anxiety symptoms (i.e. anxiety sensitivity). Each item's scale ranges from 0 (very little) to 4 (very much).	Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107
Primary	BSI 18 (Brief Symptom Inventory)	The Brief Symptom Inventory-18 (BSI-18) is a self-report measure consisting of 18 items, designed to effectively assess general mental health. Each item represents a symptom, and respondents are asked to rate these symptoms on a five-point scale, based on how much they have been bothered by the symptom in the prior week. The BSI-18 measure has three dimensions: somatization, depression, and anxiety; each contains 6 items.	Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107
Primary	DES-II (Dissociative Experiences Scale)	The DES-II is a self-administered 28-item questionnaire, designed to measure the frequency of dissociative experiences of individuals. Score in this questionnaire ranges from 0 to 100, with higher score indicating higher dissociative symptoms and severity. For each item, respondents indicate how often a particular experience occurred to them, from "never" (0% of the time) to "always" (100%).	Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107
Primary	DERS (Difficulties in Emotion Regulation Scale)	The Difficulties in Emotion Regulation Scale - 16 item version (DERS-16) is a self-report measure that assesses individuals' typical levels of difficulties in emotion regulation. The total score ranges from 16 to 80, with higher scores indicating greater difficulty regulating emotions.	Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107
Primary	NSESSS (The National Stressful Events Survey Acute Stress Disorder Short Scale)	The National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS) is a 7-item scale that assesses the severity of acute stress disorder symptoms after experiencing a highly stressful event or experience. Each item is rated on a 5-point scale, with 0 indicating 'Not at all' and 4 indicating ' Extremely'. Individuals are asked to rate the severity of his or her posttraumatic stress disorder during the past 7 days. The total score can range from 0 to 28, with higher scores indicating greater severity of acute stress disorder.	Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107
Primary	SASRQ (Stanford Acute Stress Reaction Questionnaire)	The SASRQ is a 30-item self-report questionnaire that is designed to evaluate the severity of traumatic stress symptoms over the past four weeks. The total score in this measure ranges from 0 to 150, with higher scores indicating more severe traumatic stress symptoms.	Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107
Primary	Exposure to traumatic event during the current war	This measure will be composed of 4 items that will require participants to indicate whether they have experienced a traumatic event during the current war. Participants will need to specify the type of traumatic event, its severity and whether they have begun a psychological/ psychiatric treatment during this time.; In the first baseline session the questions will refer to exposure to traumatic events during the war (up to the present moment). In all subsequent sessions, exposure to traumatic events will refer to events that occurred since the latest session.	Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107
Primary	PDEQ (Peritraumatic Dissociative Experiences Questionnaire)	The PDEQ is a self-report questionnaire consisting of 10 items, designed to assess peritraumatic dissociation. Respondents are asked to rate on a 5-point Likert scale ranging from 1 (Not at all true) to 5 (Extremely true), based on how much each statement relates to their experience during the traumatic event. The PDEQ has well-established psychometric properties, with higher total scores indicating increased peritraumatic dissociation.	Experimental group - day 1, waiting list group - days 1 and 7
Primary	TIS (Tonic Immobility Scale)	TIS is a commonly used questionnaire to assess tonic immobility during traumatic events. This self-report instrument is divided into two parts: Tonic Immobility (7 items) and Fear (3 items). Each item is rated on a 7-point Likert scale. The range of the total score is between 0 and 60, with higher scores indicating more tonic immobility and fear during the event.	Experimental group - day 1, waiting list group - days 1 and 7
Primary	PDI (The Peritraumatic Distress Inventory)	The PDI questionnaire is used to measure distress at the time of injury and consists of 13 items, with responses given on a 4-point Likert scale. The total score can range from 0 to 52, with higher scores representing greater symptom burden.	Experimental group - day 1, waiting list group - days 1 and 7
Primary	Questionnaires to test user experience of the system	This questionnaire will be composed of 7 items on a 7-point scale and is designed to evaluate the system's ease of use, the degree to which it is easy to learn it, and its overall user experience. Higher total scores will represent a more positive user experience from the system.	Experimental group - day 7, waiting list group - day 14
Primary	Questionnaire for examining the experience of the intervention	This questionnaire will consist of 3 items on a 7-point scale and will be used to assess the participant's satisfaction with the intervention, the extent to which it is helpful, and the overall experience. Higher total scores will represent a more positive user experience from the system.	Experimental group - day 7, waiting list group - day 14
Primary	Qualitative interview	Approximately 20 subjects from the original sample will participate in a qualitative interview that will last about 30 minutes. The questions of the interview will focus on the experience of the participant from the system and their thought on its content.	Experimental group - day 97, waiting list group - day 104
Primary	Questionnaire regarding receiving emotional treatment	Participants will be asked whether they have received emotional treatment (psychological, counseling, etc.) or medication since entering the study.	Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107