NCT06277973

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Tel Aviv University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Post-traumatic Stress Disorder
• Acute Stress Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-01-01
• Completion: 2025-05-01
• First posted: 2024-02-26
• Last updated: 2024-03-27

Locations

1 site across 1 country: Israel