Pharmacologic Treatment of PTSD in Sexually Abused Children

Allegheny Health Network (AHN)

Status and phase: Completed; Phase 3

Conditions: Stress Disorders, Post-Traumatic

Treatments: Behavioral: Trauma-Focused Cognitive Behavioral Therapy; Drug: Sertraline Pill; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00078767

K02MH001938 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will evaluate the benefit of adding sertraline (Zoloft®) to Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for sexually abused children who have Posttraumatic Stress Disorder (PTSD).

Full description

Adult research has demonstrated the efficacy of selective serotonin reuptake inhibitors (SSRIs) in decreasing Posttraumatic Stress Disorder (PTSD) symptoms; to date the SSRIs are the only medication class with demonstrated efficacy in treating all three PTSD symptom clusters (reexperiencing, avoidance, and hyperarousal). No studies have evaluated the impact of SSRIs on PTSD symptoms in children or adolescents. Trauma-focused CBT has been shown in several studies to be efficacious in decreasing PTSD symptoms in sexually abused children and adolescents. Many children and youth with PTSD are currently prescribed SSRIs and other medications. This study will evaluate whether adding the SSRI sertraline provides additional benefits over TF-CBT treatment for sexually abused children and adolescents with PTSD. If adequate numbers of children with comorbid PTSD and depressive and/or anxiety disorders are included, it may also be possible to evaluate whether any benefit of adding sertraline is restricted to those children with comorbid disorders.

Enrollment: 24 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

1. Ages 10-17 years, inclusive
2. Confirmed sexual abuse
3. At least 5 PTSD symptoms on KSADS-PL, with at least one symptom in each of 3 symptom clusters (reexperiencing, avoidance, arousal)
4. Parent/primary caregiver available to participate in treatment
5. Assent with parental consent to participate

Exclusion:

1. Non-English speaking
2. schizophrenia or other severe psychotic disorder
3. MR (IQ<60) or PDD preventing CBT treatment
4. taking current psychotropic medication
5. documented substance dependence (substance abuse allowed)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups

TF-CBT + sertraline

Experimental group

Description:

Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day

Treatment:

Drug: Sertraline Pill

Behavioral: Trauma-Focused Cognitive Behavioral Therapy

TF-CBT +placebo

Active Comparator group

Description:

Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)

Treatment:

Drug: Sertraline Pill

Drug: Placebo Oral Tablet