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

Tel Aviv University

Status: Not yet enrolling

Conditions: Acute Stress Disorder; Post-traumatic Stress Disorder

Treatments: Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)

Study type: Interventional

Funder types: Other

Identifiers

NCT06277973

0007551-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Immediate Stabilization Procedure

Experimental group

Description:

Participants in this arm will answer questionnaires and go through the intervention according to this schedule: Day 1 - questionnaires (T1) Day 4 - intervention Day 7 - questionnaires (T2) Day 97 - follow up questionnaires (T3)

Treatment:

Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)

Waiting list

Other group

Description:

Participants in this arm will answer questionnaires and do the intervention according to this schedule: Day 1 - questionnaires (T0) Day 7 - questionnaires (T1) Day 11- intervention Day 14- questionnaires (T2) Day 104- follow up questionnaires (T3) Thus, unlike in the experimental arm, the intervention will be delayed by a week and participants will fill out questionnaires one additional time, a week before they begin the same protocol as the experimental arm.

Treatment:

Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)