NCT00127673

Brief Summary

This study will compare the short- and long-term effectiveness of two different treatments for people with post-traumatic stress disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2005

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
10.8 years until next milestone

Results Posted

Study results publicly available

May 24, 2022

Completed
Last Updated

May 24, 2022

Status Verified

April 1, 2022

Enrollment Period

6.9 years

First QC Date

August 5, 2005

Results QC Date

July 11, 2016

Last Update Submit

April 28, 2022

Conditions

Post-Traumatic Stress Disorder

Keywords

AntidepressantsCognitive behavior therapy

Outcome Measures

Primary Outcomes (3)

  • PTSD Symptoms

    total score, range from 0-80, higher scores are more severe

    Post-treatment, ten weeks

  • Depression Symptoms

    Hamilton Depression Rating Scale (HAMD), total score, scoring range 0-50, with higher scores more severe depression

    Measured at Post-Treatment, at 10 weeks

  • State Anxiety

    State-Trait Anxiety Inventory - State version, total score, scoring range, 0-63, with higher scores more severe

    Measured at Post-Treatment, at 10 weeks

Secondary Outcomes (1)

  • Quality of Life Functioning

    Measured at Post-Treatment, at 10 weeks

Study Arms (4)

CBT no choice

ACTIVE COMPARATOR

Participants will receive no choice cognitive behavioral therapy (CBT no choice)

Behavioral: Cognitive behavioral therapy (CBT)

CBT choice

ACTIVE COMPARATOR

Participants will receive choice cognitive behavioral therapy (CBT choice)

Behavioral: Cognitive behavioral therapy (CBT)

sertraline no choice

ACTIVE COMPARATOR

Participants will receive no choice sertraline (sertraline no choice)

Drug: Sertraline

sertraline choice

ACTIVE COMPARATOR

Participants will receive choice sertraline (sertraline choice)

Drug: Sertraline

Interventions

SertralineDRUG

The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.

Also known as: Zoloft
sertraline choicesertraline no choice
Cognitive behavioral therapy (CBT)BEHAVIORAL

CBT will include 10 weekly sessions of individual cognitive behavioral therapy.

Also known as: Prolonged exposure (PE)
CBT choiceCBT no choice

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM-IV diagnosis of PTSD
  • Experienced traumatic event at least 12 weeks prior to study entry
  • Willingness to discontinue current CBT or antidepressant treatment

You may not qualify if:

  • Current diagnosis of schizophrenia or delusional disorder
  • Medically unstable bipolar disorder, depression with psychotic features, or depression requiring psychiatric treatment
  • 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 either CBT or sertraline
  • Medical contraindication for sertraline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (7)

  • Gauthier GM, PeConga EK, Mohr JL, Feeny NC, Zoellner LA. Prospective stability of memory for peritraumatic dissociation and anxiety: Replication and extension examining PTSD treatment modality and response. Psychol Trauma. 2025 Feb;17(2):429-437. doi: 10.1037/tra0001790. Epub 2024 Nov 7.

    PMID: 39509231DERIVED

  • Rosencrans PL, Zoellner LA, Feeny NC. A network approach to posttraumatic stress disorder: Comparing interview and self-report networks. Psychol Trauma. 2024 Feb;16(2):340-346. doi: 10.1037/tra0001151. Epub 2021 Oct 21.

    PMID: 34672659DERIVED

  • Graham B, Garcia NM, Bergman HE, Feeny NC, Zoellner LA. Prolonged Exposure and Sertraline Treatments for Posttraumatic Stress Disorder Also Improve Multiple Indicators of Social Functioning. J Trauma Stress. 2020 Aug;33(4):488-499. doi: 10.1002/jts.22570. Epub 2020 Jul 13.

    PMID: 32662191DERIVED

  • Zoellner LA, Roy-Byrne PP, Mavissakalian M, Feeny NC. Doubly Randomized Preference Trial of Prolonged Exposure Versus Sertraline for Treatment of PTSD. Am J Psychiatry. 2019 Apr 1;176(4):287-296. doi: 10.1176/appi.ajp.2018.17090995. Epub 2018 Oct 19.

    PMID: 30336702DERIVED

  • Le QA, Doctor JN, Zoellner LA, Feeny NC. Effects of treatment, choice, and preference on health-related quality-of-life outcomes in patients with posttraumatic stress disorder (PTSD). Qual Life Res. 2018 Jun;27(6):1555-1562. doi: 10.1007/s11136-018-1833-4. Epub 2018 Mar 14.

    PMID: 29541927DERIVED

  • Le QA, Doctor JN, Zoellner LA, Feeny NC. Cost-effectiveness of prolonged exposure therapy versus pharmacotherapy and treatment choice in posttraumatic stress disorder (the Optimizing PTSD Treatment Trial): a doubly randomized preference trial. J Clin Psychiatry. 2014 Mar;75(3):222-30. doi: 10.4088/JCP.13m08719.

    PMID: 24717377DERIVED

  • Le QA, Doctor JN, Zoellner LA, Feeny NC. Minimal clinically important differences for the EQ-5D and QWB-SA in Post-traumatic Stress Disorder (PTSD): results from a Doubly Randomized Preference Trial (DRPT). Health Qual Life Outcomes. 2013 Apr 12;11:59. doi: 10.1186/1477-7525-11-59.

    PMID: 23587015DERIVED

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

SertralineCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Norah C Feeny
Organization
Case Western Reserve University
ncf2@case.edu
2163682695

Study Officials

  • Norah C. Feeny, PhD

    Department of Psychology, Case Western Reserve University

    PRINCIPAL INVESTIGATOR

  • Lori A. Zoellner, PhD

    Department of Psychology, University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 5, 2005

First Posted

August 8, 2005

Study Start

September 1, 2004

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

May 24, 2022

Results First Posted

May 24, 2022

Record last verified: 2022-04

Locations

US(1)