Clinical Trial

Clinician-Assisted Videofeedback Exposure-Approach Therapy (CAVEAT) Trial

Study acronym: CAVEAT
Recruiting
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Record status
This record was last updated August 13, 2024 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
The first study proposed is a small (n= 10 to 12 maximum) open feasibility trial of CAVEAT which is a 16-session manualized brief psychotherapy prototcol that is designed to help mothers of infants and young children, whereby the mothers have been exposed to interpersonal violence (i.e. childhood maltreatment and family violence, intimate and non-intimate partner violence, interpersonal combat and or other forms of terrorism or political violence including physical and sexual assault) and who have developed related post-traumatic stress. The treatment uses an integration and extension of evidence-based techniques: Modified Interaction Guidance, Prolonged Exposure Therapy for PTSD, Child-Parent Psychotherapy, and Minding the Baby, in order to help mothers with post-traumatic dysregulation and difficulty in their maintaining sensitivity during challenging parent-child interactions (i.e. when mothers are confronted with child helpless states, emotion dysregulation, negative affect and child aggression). Outcome measures will initially include: maternal attributions towards her child (i.e. perception of child's personality), maternal-child behavior, and maternal-child symptoms of attachment disturbance and PTSD. This feasibility study is meant to perfect the manual and to prepare for an initial open trial with a larger clinical sample including analysis of pre- and post-intervention measures before further randomized control study can be done.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-06-21; most recent amendment 2024-08-09.
Status change: Not Yet Recruiting → Recruiting 2024-08-09
Trial Details
NCT Number NCT05927324
Lead Sponsor University of Lausanne Hospitals
Collaborators: International Psychoanalytical Association
Conditions Post-traumatic Stress Disorder
Enrollment 24 participants
Start Date 2024-07-01
Primary Completion 2025-09-30 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-08-13