Clinical trial NCT06277973: Feasibility Study of the Self-Care Immediate Stabilization Procedure (ISP) ® After a Traumatic Experience
Official title: Self-Care Immediate Stabilization Procedure (ISP) ® After a Traumatic Experience - A Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-traumatic Stress Disorder
Acute Stress Disorder
Keywords: Post-traumatic stress disorder (PTSD)
EMDR (Eye Movement Desensitization Reprocessing)
Immediate Stabilization Procedure [IPS(R)]
The 'Butterfly Hug'
Acute Stress Disorder
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated to one of the following groups: the experiment group and the waiting list group. Each group will receive the intervention but in the waiting list group this will occur a week later:

Experiment group:

Day 1 - questionnaires (T1) Day 4 - intervention Day 7 - questionnaires (T2) Day 97 - follow up questionnaires (T3)

Waiting list group:

Day 1 - questionnaires (T0) Day 7 - questionnaires (T1) Day 11- intervention Day 14- questionnaires (T2) Day 104- follow up questionnaires (T3) The parallel element of this model lies in the first week of the study: the experiment group goes through 2 measurements with the intervention in the middle of the week, whereas the waiting list group goes through 2 measurements without the intervention.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: PCL-5 (Posttraumatic Stress Disorder Checklist)
timeFrame: Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107
measure: GAD-7 (General Anxiety Disorder-7)
timeFrame: Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107
measure: SSASI (The Short Scale Anxiety Sensitivity Index)
timeFrame: Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107
measure: BSI 18 (Brief Symptom Inventory)
timeFrame: Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107
measure: DES-II (Dissociative Experiences Scale)
timeFrame: Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107
measure: DERS (Difficulties in Emotion Regulation Scale)
timeFrame: Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107
measure: NSESSS (The National Stressful Events Survey Acute Stress Disorder Short Scale)
timeFrame: Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107
measure: SASRQ (Stanford Acute Stress Reaction Questionnaire)
timeFrame: Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107
measure: Exposure to traumatic event during the current war
timeFrame: Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107
measure: PDEQ (Peritraumatic Dissociative Experiences Questionnaire)
timeFrame: Experimental group - day 1, waiting list group - days 1 and 7
measure: TIS (Tonic Immobility Scale)
timeFrame: Experimental group - day 1, waiting list group - days 1 and 7
measure: PDI (The Peritraumatic Distress Inventory)
timeFrame: Experimental group - day 1, waiting list group - days 1 and 7
measure: Questionnaires to test user experience of the system
timeFrame: Experimental group - day 7, waiting list group - day 14
measure: Questionnaire for examining the experience of the intervention
timeFrame: Experimental group - day 7, waiting list group - day 14
measure: Qualitative interview
timeFrame: Experimental group - day 97, waiting list group - day 104
measure: Questionnaire regarding receiving emotional treatment
timeFrame: Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
affiliation: Tel Aviv University
name: Oren Asman, LLD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel Aviv University
name: Yael Lahav, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
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