This is a feasibility and acceptability study of Written Exposure Therapy (WET) for PTSD in pregnant and postpartum adolescents and youth with PTSD.
The main goal of this research study is to investigate whether a short trauma-focused therapy involving writing is something teens and young adults who are pregnant or recently had a baby and have symptoms related to post-traumatic stress disorder (PTSD) are able to complete. This study is specifically examining the feasibility and acceptability of Written Exposure Therapy (WET) as a treatment in this population. WET is a type of therapy where people write about a traumatic experience they have gone through, and their feelings about the event. Doing this over several sessions may help some people reduce how distressing the memory is to them over time. In addition, this study aims to investigate if WET can reduce symptoms related to PTSD in teens and young adults who are pregnant or have had a baby in the last year. The study will also explore if it is possible to gather enough information on measurements like heart rate and sleep patterns with smart watches in the same population, to look at brain patterns before and after the therapy, and to see if WET can improve emotions, functioning, and relationships in pregnant and post-partum individuals. Prior to initiating the course of WET, participants will undergo screening procedures to evaluate eligibility. Those eligible will complete 5 sessions of written exposure therapy, one session per week and biomarker data will be collected via a wearable device. Participants will also undergo optional electroencephalography (EEG) as well as self-report and clinician-rated assessments. Follow-up visits will be conducted at 4, 8 and 12 weeks post-baseline (post-treatment for WET), with weekly assessments. The baseline visit must be done in-person in order to set up the smart watch. If participants choose to undergo electroencephalography, they will be required to come in-person for the procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
WET may be an optimal treatment for pregnant or postpartum adolescents and youth with PTSD in a low resource setting. WET addresses many of the barriers above. It is delivered in just 5 sessions, with no homework, and may promote a sense of self-efficacy in adolescents and youth due to the nature of writing assignments and brief therapist involvement. It is attractive in resource-poor settings because just 10-15 min of direct therapist time per follow-up session is needed.
UT Southwestern Center for Depression Research and Clinical Care
Dallas, Texas, United States
RECRUITINGFeasibility of Written Exposure Therapy
Feasibility will be assessed based on recruitment, retention and treatment adherence rates. Acceptability will be evaluated through participant feedback, including satisfaction with the intervention and willingness to engage in treatment. The primary outcome will be the percentage of participants who complete treatment within 4 weeks, for a 12-week study period. We expect at least 70% of participants will be able to complete treatment within 4 weeks.
Time frame: From enrollment to study exit visit at week 12
Changes in PTSD Symptom Severity Assessed by the Clinician Administered Scale for PTSD (CAPS-5)
The Clinician-Administered PTSD Scale for DSM-5 - Child/Adolescent Version (CAPS-CA-5) is a 30-item clinician-administered PTSD scale based upon DSM-5 criteria for children and adolescents ages 7 and above. It is a modified version of the CAPS-5 that includes age-appropriate items and picture response options. It will be used to diagnose PTSD or subthreshold PTSD and obtain data on the frequency and severity of PTSD symptoms. The worst traumatic event identified in the LSC-R from baseline will be used for all CAPS-CA-5 administrations. Preliminary effectiveness will be measured by assessing changes in the CAPS-5 score at 4,8, and 12 weeks after baseline visit.
Time frame: From enrollment to study exit visit at week 12
Changes in PTSD Symptoms Assessed by the PTSD Checklist for DSM-5
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Scores range from 0 to 80 and a score above 21 is indicative of probable PTSD. A 10-20 point change represents clinically significant change.
Time frame: From enrollment to study exit visit at week 12
Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report measure to evaluate sleep quality, duration, and functioning.
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Time frame: From enrollment to study exit visit at week 12
Changes in Emotional Regulation Assessed by the Difficulties in Emotion Regulation Scale (DERS-16)
The Difficulties in Emotion Regulation Scale - 16 item version (DERS-16) is a 16-item assessment of emotion regulation difficulties, rated on a 5-point Likert scale.
Time frame: From enrollment to study exit visit at week 12
Changes in Anxiety Assessed by the Perinatal Anxiety Screening Scale (PASS)
The Perinatal Anxiety Screening Scale (PASS) is a 31-item self-rated questionnaire investigating anxiety symptoms during the last month in child-bearing women. Scores may range 0-93 and cutoff for clinical anxiety is ≥26.
Time frame: From enrollment to study exit visit at week 12