Post-Traumatic Stress Disorder
Conditions
Keywords
Antidepressants, Cognitive behavior therapy
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.
Interventions
DRUGSertraline
The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
BEHAVIORALCognitive behavioral therapy (CBT)
CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
Sponsors
National Institute of Mental Health (NIMH)
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Symptoms | Post-treatment, ten weeks | total score, range from 0-80, higher scores are more severe |
| Depression Symptoms | Measured at Post-Treatment, at 10 weeks | Hamilton Depression Rating Scale (HAMD), total score, scoring range 0-50, with higher scores more severe depression |
| State Anxiety | Measured at Post-Treatment, at 10 weeks | State-Trait Anxiety Inventory - State version, total score, scoring range, 0-63, with higher scores more severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Functioning | Measured at Post-Treatment, at 10 weeks | Sheehan Disability Scale (SDS), total score, scoring range 0-30 , higher scores indicative of worse functional impairment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NoChoice_CBT Participants will receive no choice cognitive behavioral therapy
Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy. | 48 |
| Choice_CBT Participants will receive choice cognitive behavioral therapy
Cognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy. | 61 |
| NoChoice_SER Participants will receive no choice sertraline
Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist. | 55 |
| Choice_SER Participants will receive choice sertraline
Sertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist. | 36 |
| Total | 200 |
Baseline characteristics
| Characteristic | NoChoice_CBT | Choice_CBT | NoChoice_SER | Choice_SER | Total |
|---|---|---|---|---|---|
| Age, Continuous | 36.2 years STANDARD_DEVIATION 11.4 | 37.1 years STANDARD_DEVIATION 11.3 | 38.9 years STANDARD_DEVIATION 11.3 | 38.3 years STANDARD_DEVIATION 11.4 | 36.60 years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 3 Participants | 3 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 58 Participants | 52 Participants | 33 Participants | 190 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 6 Participants | 2 Participants | 0 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 12 Participants | 12 Participants | 9 Participants | 43 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 3 Participants | 1 Participants | 11 Participants |
| Race (NIH/OMB) White | 30 Participants | 38 Participants | 38 Participants | 24 Participants | 130 Participants |
| Sex: Female, Male Female | 38 Participants | 46 Participants | 43 Participants | 25 Participants | 152 Participants |
| Sex: Female, Male Male | 10 Participants | 15 Participants | 12 Participants | 11 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 48 | 3 / 61 | 4 / 55 | 5 / 36 |
| serious Total, serious adverse events | 1 / 48 | 2 / 61 | 0 / 55 | 0 / 36 |
Outcome results
Primary
Depression Symptoms
Hamilton Depression Rating Scale (HAMD), total score, scoring range 0-50, with higher scores more severe depression
Time frame: Measured at Post-Treatment, at 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT no Choice | Depression Symptoms | 10.33 units on a scale | Standard Deviation 10.33 |
| CBT Choice | Depression Symptoms | 12.13 units on a scale | Standard Deviation 8.67 |
| Sertraline no Choice | Depression Symptoms | 15.24 units on a scale | Standard Deviation 13.9 |
| Sertraline Choice | Depression Symptoms | 12.11 units on a scale | Standard Deviation 10.12 |
Primary
PTSD Symptoms
total score, range from 0-80, higher scores are more severe
Time frame: Post-treatment, ten weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT no Choice | PTSD Symptoms | 10.02 units on a scale | Standard Deviation 10.27 |
| CBT Choice | PTSD Symptoms | 10.87 units on a scale | Standard Deviation 8.75 |
| Sertraline no Choice | PTSD Symptoms | 15.12 units on a scale | Standard Deviation 14.03 |
| Sertraline Choice | PTSD Symptoms | 10.78 units on a scale | Standard Deviation 7.59 |
Primary
State Anxiety
State-Trait Anxiety Inventory - State version, total score, scoring range, 0-63, with higher scores more severe
Time frame: Measured at Post-Treatment, at 10 weeks
Population: Completer analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT no Choice | State Anxiety | 39.16 units on a scale | Standard Deviation 13.83 |
| CBT Choice | State Anxiety | 38.79 units on a scale | Standard Deviation 13.13 |
| Sertraline no Choice | State Anxiety | 46.89 units on a scale | Standard Deviation 18.91 |
| Sertraline Choice | State Anxiety | 38.72 units on a scale | Standard Deviation 12.48 |
Secondary
Quality of Life Functioning
Sheehan Disability Scale (SDS), total score, scoring range 0-30 , higher scores indicative of worse functional impairment
Time frame: Measured at Post-Treatment, at 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT no Choice | Quality of Life Functioning | 8.82 units on a scale | Standard Deviation 6.24 |
| CBT Choice | Quality of Life Functioning | 11.68 units on a scale | Standard Deviation 8.23 |
| Sertraline no Choice | Quality of Life Functioning | 14.06 units on a scale | Standard Deviation 10.38 |
| Sertraline Choice | Quality of Life Functioning | 10.78 units on a scale | Standard Deviation 9.4 |