Overview

This trial is active, not recruiting.

Condition posttraumatic stress disorder
Treatments prolonged exposure (pe), pe plus sertraline
Phase phase 3
Sponsor Case Western Reserve University
Collaborator University of Washington
Start date March 2011
End date January 2017
Trial size 150 participants
Trial identifier NCT01600456, Optimizing1, R01MH066347-07, R01MH066348-07

Summary

The specific aims of this study are:

1. To compare the effectiveness of a cognitive behavioral therapy (prolonged exposure, PE) to that of PE and medication (sertraline).

2. To compare the durability of PE gains to that of PE and sertraline at 3, 6, and 9 months post-treatment.

3. To compare those who have chosen their treatment to those who have not in terms of completion of treatment, treatment satisfaction, and short- and long-term effectiveness of the treatment.

4. To examine cost effectiveness of treatment delivery to trauma survivors with PTSD.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Participants randomized to "choice" who choose prolonged exposure (PE).
prolonged exposure (pe)
PE will include 10 weekly sessions of individual cognitive behavioral therapy.
(Active Comparator)
Participants randomized to "choice" who choose PE plus sertraline.
prolonged exposure (pe)
PE will include 10 weekly sessions of individual cognitive behavioral therapy.
pe plus sertraline Zoloft
PE plus sertraline will include 10 weeks of prolonged exposure therapy plus sertraline. The sertraline dose will be up to 200 mg daily for 10 weeks. There will also be frequent meetings with study psychiatrist. PE will be provided 1x weekly for 10 weeks.
(Active Comparator)
Participants randomized to "no choice" who are then randomized to PE.
prolonged exposure (pe)
PE will include 10 weekly sessions of individual cognitive behavioral therapy.
(Active Comparator)
Participants randomized to "no choice" who are then randomized to PE plus sertraline.
prolonged exposure (pe)
PE will include 10 weekly sessions of individual cognitive behavioral therapy.
pe plus sertraline Zoloft
PE plus sertraline will include 10 weeks of prolonged exposure therapy plus sertraline. The sertraline dose will be up to 200 mg daily for 10 weeks. There will also be frequent meetings with study psychiatrist. PE will be provided 1x weekly for 10 weeks.

Primary Outcomes

Measure
Posttraumatic stress disorder (PTSD) Symptoms
time frame: Measured up to 9 months.

Secondary Outcomes

Measure
Depression symptoms
time frame: Measured up to 9 months.

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - DSM-IV (Diagnostic & Statistical Manual of Mental Disorders) diagnosis of PTSD (with severity threshold) - Experienced traumatic event at least 12 weeks prior to study entry - Willingness to discontinue current CBT or antidepressant treatment if needed Exclusion Criteria: - Current diagnosis of schizophrenia or delusional disorder - Medically unstable bipolar disorder, depression with psychotic features, or depression requiring immediate psychiatric treatment - No clear trauma memory or trauma before age 3 - Current diagnosis of alcohol or substance dependence within 3 months prior to study entry - Ongoing intimate relationship with the perpetrator of the traumatic event - History of nonresponse to adequate trial of either CBT or sertraline - Medical contraindication for sertraline - Current high dose use of benzodiazepines - Pregnant or sexually active female without adequate birth control

Additional Information

Official title Optimizing PTSD Treatment: PE Versus PE Plus Sertraline
Principal investigator Norah C Feeny, PhD
Description Exposure to traumatic events, such as automobile accidents and physical or sexual assault, can cause individuals to develop persistent psychological difficulties such as post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder characterized by avoidance, hyperarousal symptoms, and mental re-experiencing of the traumatic event. PTSD is a serious condition that may cause social and psychological impairment; therefore, safe and effective treatments are needed. Both CBT (cognitive behavior therapy) and antidepressant therapy have been shown to effectively treat PTSD symptoms; however, comparisons of the treatments are limited. This study will compare the short- and long-term effectiveness of prolonged exposure and prolonged exposure plus the antidepressant sertraline. Participants will either be randomly assigned to prolonged exposure (PE) or PE plus sertraline, or they will be able to choose one of the two treatments,which will be given for 10 weeks, followed by 9 months of follow-up assessments. Participants in the PE group will have 10 weekly sessions of therapy. During the therapy sessions, participants will be encouraged to confront their general fears and the memory of their trauma through repeated storytelling. Participants will also be encouraged to practice the techniques learned in therapy in everyday life. Participants in the PE plus sertraline group receive the same treatment as the PE group plus they will take sertraline daily for 10 weeks. These participants will be seen regularly by a psychiatrist who will offer general encouragement and support, monitor response to medication, and record any side effects participants may be experiencing. The medication may be adjusted according to a dosing schedule and based on the study doctor's judgment. At the end of 10 weeks, participants in the PE plus sertraline group will have the choice of either tapering the medication gradually to minimize the chance of withdrawal symptoms or staying on the medication for up to 9 months. Participants who do not respond to their assigned or chosen treatment will be offered booster sessions or the other treatment for 10 weeks. Self-report scales and questionnaires will be used to assess participants' PTSD symptoms, depression, anxiety, and social functioning. These assessments will occur at 3, 6, and 9 months after the study treatment period.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Case Western Reserve University.