PTSD
Conditions
Keywords
randomized controlled trial, PTSD, cognitive behavioral treatment, group treatment
Brief summary
The purpose of this study is to examine whether group cognitive behavioral treatment (GCBT) is efficacious in the treatment of PTSD in a sample of male Veterans. Veterans with a primary diagnosis of chronic PTSD will be randomly assigned to either GCBT or a supportive group treatment condition. Both treatments will consist of 14, weekly sessions. Assessment of PTSD and related symptoms will be conducted at pre-treatment, mid treatment, post-treatment, and 3-, 6-, - and 12-month follow-up.
Detailed description
The mental health needs of Veterans within the VA Healthcare system are notable. With the substantial increase over the past 10 years in Veterans seeking Posttraumatic Stress Disorder (PTSD) treatment services, the VA system is straining to accommodate these needs, relying heavily on group-based treatments. The proposed research will take the next step in the literature on group psychotherapy for PTSD by examining a group cognitive behavioral treatment (GCBT) program with promising pilot data. This application supports a randomized controlled trial, which will compare GCBT with Supportive Group Psychotherapy (SGP). The trial will involve 196 male Veterans with combat-related PTSD who will be randomly assigned to GCBT (n= 98) or SGP (n =98) to determine efficacy within a naturalistic care environment. Outcome data will be collected pre-treatment, mid-treatment, post-treatment, and 3-, 6- and 12-month follow-up. Two aims are included, one focusing on outcome with respect to PTSD symptom severity, the second focusing on treatment generalization to comorbid emotional disorders (major depressive disorder, generalized anxiety disorder, and alcohol abuse), and distress and impairment. Data will be examined using latent growth curve modeling, with emphasis on determining efficacy and effectiveness. The information provided by the proposed project could assist in developing more effective care models for individuals with chronic PTSD from numerous traumatic experiences. Additionally, this project represents an effort to move the literature on group-based treatments for PTSD ahead, through inclusion of advanced methodological and analytic approaches.
Interventions
BEHAVIORALGroup Cognitive Behavioral Treatment (GCBT)
GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention.
BEHAVIORALPresent Centered Group Treatment
The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* primary diagnosis of DSM-IV (American Psychiatric Association, 2000) criteria for chronic, PTSD (symptoms lasting 3 months or more) * male, Veteran * be free of psychosis and impaired cognitive function caused by traumatic brain injury or dementia
Exclusion criteria
* a current diagnosis of substance dependence or unstable bipolar disorder * currently involved in psychosocial treatment for PTSD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | 12 months | The CAPS-5 is a semi-structured interview to assess presence and severity of PTSD symptoms. The total score on the CAPS will be used as the primary outcome measure in this study. Total score range = 0-80; higher scores indicate greater symptom severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory, II (BDI-II) | 12 months | The BDI is a self-report inventory that indexes depression symptom severity. Total score range = 0-63; higher scores indicate greater symptom severity. |
| Short-Form Health Survey (SF-36) | 12 months | The SF-36 is a measure of functional impairment. Total score range = 0-200; higher scores indicate greater functioning. |
| Beck Anxiety Inventory (BAI) | 12 months | The BAI is a self-report measure of general anxiety symptom severity. Total score range = 0-63; higher scores indicate greater symptom severity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group Cognitive Behavioral Treatment (GCBT) Group Cognitive Behavioral Treatment (GCBT): GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention. | 98 |
| Present Centered Group Treatment Present Centered Group Treatment: The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors. | 100 |
| Total | 198 |
Baseline characteristics
| Characteristic | Present Centered Group Treatment | Group Cognitive Behavioral Treatment (GCBT) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 33 Participants | 23 Participants | 56 Participants |
| Age, Categorical Between 18 and 65 years | 67 Participants | 75 Participants | 142 Participants |
| Age, Continuous | 57.22 years STANDARD_DEVIATION 12.51 | 54.40 years STANDARD_DEVIATION 11.44 | 55.82 years STANDARD_DEVIATION 12.05 |
| Beck Anxiety Inventory (BAI) | 20.97 units on a scale STANDARD_DEVIATION 12.15 | 18.22 units on a scale STANDARD_DEVIATION 11.31 | 19.61 units on a scale STANDARD_DEVIATION 11.8 |
| Beck Depression Inventory, II (BDI-II) | 23.94 units on a scale STANDARD_DEVIATION 11.65 | 23.85 units on a scale STANDARD_DEVIATION 11.95 | 23.89 units on a scale STANDARD_DEVIATION 11.77 |
| Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | 39.37 units on a scale STANDARD_DEVIATION 9.52 | 39.84 units on a scale STANDARD_DEVIATION 9.84 | 39.60 units on a scale STANDARD_DEVIATION 9.66 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 14 Participants | 33 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 6 Participants | 14 Participants |
| Race (NIH/OMB) White | 72 Participants | 75 Participants | 147 Participants |
| Region of Enrollment United States | 100 Participants | 98 Participants | 198 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 100 Participants | 98 Participants | 198 Participants |
| Short-Form Health Survey (SF-36) | 42.88 units on a scale STANDARD_DEVIATION 26.37 | 39.43 units on a scale STANDARD_DEVIATION 26.6 | 41.18 units on a scale STANDARD_DEVIATION 26.47 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 98 | 0 / 100 |
| other Total, other adverse events | 0 / 98 | 0 / 100 |
| serious Total, serious adverse events | 15 / 98 | 22 / 100 |
Outcome results
Primary
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
The CAPS-5 is a semi-structured interview to assess presence and severity of PTSD symptoms. The total score on the CAPS will be used as the primary outcome measure in this study. Total score range = 0-80; higher scores indicate greater symptom severity.
Time frame: 12 months
Population: Primary treatment outcomes were examined using hierarchical linear modeling.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Cognitive Behavioral Treatment (GCBT) | Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | 28.76 units on a scale | Standard Deviation 13.46 |
| Present Centered Group Treatment | Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | 31.87 units on a scale | Standard Deviation 14.7 |
Secondary
Beck Anxiety Inventory (BAI)
The BAI is a self-report measure of general anxiety symptom severity. Total score range = 0-63; higher scores indicate greater symptom severity.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Cognitive Behavioral Treatment (GCBT) | Beck Anxiety Inventory (BAI) | 15.23 units on a scale | Standard Deviation 12.34 |
| Present Centered Group Treatment | Beck Anxiety Inventory (BAI) | 18.67 units on a scale | Standard Deviation 13.77 |
Secondary
Beck Depression Inventory, II (BDI-II)
The BDI is a self-report inventory that indexes depression symptom severity. Total score range = 0-63; higher scores indicate greater symptom severity.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Cognitive Behavioral Treatment (GCBT) | Beck Depression Inventory, II (BDI-II) | 18.95 units on a scale | Standard Deviation 12.67 |
| Present Centered Group Treatment | Beck Depression Inventory, II (BDI-II) | 22.29 units on a scale | Standard Deviation 13.2 |
Secondary
Short-Form Health Survey (SF-36)
The SF-36 is a measure of functional impairment. Total score range = 0-200; higher scores indicate greater functioning.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Cognitive Behavioral Treatment (GCBT) | Short-Form Health Survey (SF-36) | 55.00 units on a scale | Standard Deviation 28.71 |
| Present Centered Group Treatment | Short-Form Health Survey (SF-36) | 59.05 units on a scale | Standard Deviation 27.21 |