EMpower Parents: Effectiveness of EMDR Treatment for Parental PTSD Related to Their Child's Medical Condition.

Not Applicable

Not yet recruiting

• Conditions: All Acute Pediatric Conditions; All Chronic Pediatric Conditions

• Registration Number: NCT06776744
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

The goal of this clinical trial is to learn if short EMDR treatment offered in two modalities (face to face and remote) is effective in reducing PTSD symptoms and comorbid symptoms for parents of children with diverse chronic and acute medical conditions.

The main question is:

• Is short EMDR treatment effective in reducing PTSD symptoms in parents of children with chronic or acute medical conditions?

Researchers will compare in person and remote EMDR treatment to a waiting list group to see if the treatment is effective.

Participants in the intervention conditions will participate in four in person or remote EMDR sessions, each lasting 1.5 hours, spread across two half-days. Participants in the waiting list condition will receive this treatment after a period of 3 months.

Detailed Description

Objective: The primary objective is to assess the effectiveness of a brief (two half-day) in person (EMDRip) and remote (EMDRr) EMDR therapy compared to control group in reducing posttraumatic stress symptoms in parents of children with a chronic or acute medical condition.

The secondary objectives are to assess the effectiveness of brief EMDRip and EMDRr for parents of children with a severe chronic or acute medical condition 1) in reducing psychological comorbidity in parents (psychopathology in general: Depression, Anxiety, and Somatization, and parenting stress), 2) in reducing posttraumatic stress symptoms of their child with a chronic or acute medical condition, and 3) in improving relationship quality between the parent and spouse and between the parent and the child with a severe chronic or acute medical condition. 4) To evaluate the feasibility of EMDRip versus EMDRr.5) To describe the traumatic experiences and future worries (targets) the parents of children with a severe chronic or acute medical condition struggle with.

Study design: This study will be a randomized controlled trial with three study arms: in person EMDR (EMDRip), remote EMDR (EMDRr), waiting list (Control).

Intervention: The EMDR intervention in this study consists of four in person or remote EMDR sessions, each lasting 1.5 hours, spread across two half-days, approximately one week will elapse between the two treatment days. EMDR treatment will be offered by licensed therapists at Amsterdam UMC.

Study Timeline

• Study First Submitted: 2024-12-23
• Status Verified: 2025-01
• Study Start: 2025-01
• Study First Submitted QC: 2025-01-10
• Last Update Submitted: 2025-01-10
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• One of the three conditions below on the PTSD Check List for DSM-5 (PCL-5): A 'moderately or higher' (2-4) score for at least one symptom in each cluster (B, C, D or E), or Three of the four PTSD criteria (one B symptom, one C symptom, two D symptoms and two E symptoms), or A (sub) clinical total score (>24).
• Being motivated for brief EMDR treatment.
• Parenting a child under treatment of a healthcare provider at the Emma Children's Hospital, Amsterdam UMC.
• Having sufficient knowledge of the Dutch language to complete the questionnaires.

Exclusion Criteria

• Major interfering acute medical or psychiatric condition, such as psychosis, substance dependence or high risk for suicide.
• Insufficient fluency of the Dutch language.
• Receiving psychological trauma treatment by another therapist at the same time.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Posttraumatic stress (symptoms) assessed with the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)	From T0 [enrolment] to T1 [2 weeks post end of treatment]

Secondary Outcome Measures

Name	Time	Method
Psychological comorbidity - Depression assessed with the Dutch-Flemish PROMIS Item Bank v1.0 - Depression	From T0 [enrolment] to T1 [2 weeks post end of treatment]
Distress assessed with the Distress Thermometer for Parents, DT-P	From T0 [enrolment] to T1 [2 weeks post end of treatment]
Psychological comorbidity - Anxiety assessed with the Dutch-Flemish PROMIS Bank v1.0 - Anxiety	From T0 [enrolment] to T1 [2 weeks post end of treatment]
Psychological comorbidity - Somatization assessed with the Brief Symptom Inventory-18, BSI-18, subscale Somatic Symptoms	From T0 [enrolment] to T1 [2 weeks post end of treatment]
Parent-child relationship assessed with the Parenting Burden Questionnaire, OBVL	From T0 [enrolment] to T1 [2 weeks post end of treatment]
Parenting stress assessed with the Parenting Burden Questionnaire, OBVL	From T0 [enrolment] to T1 [2 weeks post end of treatment]
Trauma symptoms child assessed with the Child and Adolescent Trauma Screen, CATS, 3-6 and 7-17 parent version, based on the DSM-5 criteria for PTSD	From T0 [enrolment] to T1 [2 weeks post end of treatment]
Social support assessed with the Social Support subscale of the Family Questionnaire, GVL	From T0 [enrolment] to T1 [2 weeks post end of treatment]
Partner relationship assessed with the Partner Relationship subscale of the Family Questionnaire, GVL	From T0 [enrolment] to T1 [2 weeks post end of treatment]