Feasibility Study of the Self-Care Immediate Stabilization Procedure (ISP) ® After a Traumatic Experience
- Conditions
- Post-traumatic Stress DisorderAcute Stress Disorder
- Interventions
- Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)
- Registration Number
- NCT06277973
- Lead Sponsor
- Tel Aviv University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Hebrew speakers
- Age 18 years or older
- Have been in Israel since October 7th 2023 (the start of the war)
- Were exposed to traumatic events during the war (Alarms, participated in battles, were attacked by terrorists, etcetera)
- Access to PC/smartphone
- Basic technological skills, ability to use the internet and email.
- Diagnosed with psychotic conditions.
- Diagnosed with PTSD or complex PTSD.
- Diagnosed with alcohol use disorder or drug abuse disorder.
- Suicidal ideation
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Waiting list Eye Movement Desensitization and Reprocessing (EMDR) 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. Immediate Stabilization Procedure Eye Movement Desensitization and Reprocessing (EMDR) 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)
- Primary Outcome Measures
Name Time Method PDEQ (Peritraumatic Dissociative Experiences Questionnaire) Experimental group - day 1, waiting list group - days 1 and 7 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.
Questionnaire regarding receiving emotional treatment Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107 Participants will be asked whether they have received emotional treatment (psychological, counseling, etc.) or medication since entering the study.
GAD-7 (General Anxiety Disorder-7) Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107 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 anxietySSASI (The Short Scale Anxiety Sensitivity Index) Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107 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).SASRQ (Stanford Acute Stress Reaction Questionnaire) Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107 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.
PCL-5 (Posttraumatic Stress Disorder Checklist) Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107 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).
DES-II (Dissociative Experiences Scale) Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107 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%).
Questionnaire for examining the experience of the intervention Experimental group - day 7, waiting list group - day 14 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.
PDI (The Peritraumatic Distress Inventory) Experimental group - day 1, waiting list group - days 1 and 7 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.
BSI 18 (Brief Symptom Inventory) Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107 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.
DERS (Difficulties in Emotion Regulation Scale) Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107 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.
NSESSS (The National Stressful Events Survey Acute Stress Disorder Short Scale) Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107 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.
Qualitative interview Experimental group - day 97, waiting list group - day 104 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.
Exposure to traumatic event during the current war Experimental group - days 1, 7 and 97. Waiting list group - days 1, 7, 14 and 107 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.TIS (Tonic Immobility Scale) Experimental group - day 1, waiting list group - days 1 and 7 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.
Questionnaires to test user experience of the system Experimental group - day 7, waiting list group - day 14 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tel Aviv University
🇮🇱Tel Aviv, Israel