NCT Number: NCT06776744
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.
Trial opening soon.
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Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Eye Movement Desensitization and Reprocessing (EMDR) treatment. EMDR is one of the first-choice evidence based treatments for PTSD. During an EMDR session, the traumatic memory is brought to the surface including associated images, thoughts, feelings and body sensations, while simultaneously focusing on an external distracting stimulus (e.g., lateral eye movements).
Other names: Psychological intervention
Time frame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Time frame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Time frame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Time frame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Time frame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Time frame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Time frame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Time frame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Time frame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Time frame: From T0 [enrolment] to T1 [2 weeks post end of treatment]
Time frame: 2 weeks post treatment follow-up (T1ip, T1r, T.1.c)
To assess the feasibility of EMDR in person versus EMDR remote
Time frame: Tscreen: part of the first set-of questionnaires parents complete to check for eligibility, pre-intervention.
To assess potential therapy preference (in person, remote or hybrid) before start of treatment
Time frame: At every follow-up measurement moment: T1c: 6 weeks post T0 follow-up, T2c: 16 weeks post T0 follow-up, T1ip, T1r, T1.1c: 2 weeks post end of treatment, T2ip, T2r, T2.1c: 3 months post end of treatment, T3ip, T3r: 6 months post end of treatment.
To assess if new traumatic experiences occurred after treatment ended
Time frame: At the last measurement moment for each group: T3ip, T3r: 6 months post end of treatment T2.1c: 3 months post end of treatment
To assess if participants are in need for psychological treatment after the EMDR treatment of the study
Time frame: At the psychological intake (in between baseline measurement and the start of the intervention)
During the psychological intake, the following data is collected: 1) Complaints parents, 2) Information about child's illness, 3) Targets (traumatic experiences): title, short description, child's age, SUD (memory), intrusion, frequency, 4) Mental video check/future template, 5) Other information, 6) Psychoeducation PTSD, 7) Explanation EMDR and practice round, 8) Date, time and location of treatment.
Contact information is provided by the study sponsor or research team.
Esmée Vesseur, MSc.
CONTACT
Linde Scholten, Dr.
CONTACT
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
EMpower Parents: Effectiveness of EMDR Treatment for Parental PTSD Related to Their Child's Medical Condition: a Randomized Controlled Trial
Acronym: EMpower
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
