Clinical trial NCT00127673: Comparison of Two Treatments for Post-Traumatic Stress Disorder
Official title: Effectiveness of PTSD Treatment: CBT Versus Sertraline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Traumatic Stress Disorder
Keywords: Antidepressants
Cognitive behavior therapy
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-08-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Exposure to traumatic events, such as automobile accidents and 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 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 CBT and the antidepressant sertraline.

Participants will either be randomly assigned to CBT or sertraline, or they will be able to choose one of the two treatments, which will be given for 10 weeks, followed by 24 months of follow-up assessments. Participants in the CBT 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 antidepressant group will take sertraline daily for 10 weeks. These participants will be seen weekly 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 antidepressant 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 24 months. Participants who do not respond to their assigned or chosen treatment will be offered 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, 12, and 24 months after the study treatment period.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: PTSD Symptoms
timeFrame: Post-treatment, ten weeks
measure: Depression Symptoms
timeFrame: Measured at Post-Treatment, at 10 weeks
measure: State Anxiety
timeFrame: Measured at Post-Treatment, at 10 weeks
Secondary outcomes:
measure: Quality of Life Functioning
timeFrame: Measured at Post-Treatment, at 10 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Department of Psychology, University of Washington
state: Washington
Study officials:
affiliation: Department of Psychology, Case Western Reserve University
name: Norah C. Feeny, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychology, University of Washington
name: Lori A. Zoellner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.