Depression, Insomnia Disorder, Posttraumatic Stress Disorder
Conditions
Keywords
Posttraumatic Stress Disorder, Depression, Sleep Initiation and Maintenance Disorders, Insomnia, Psychotherapy, Group, Cognitive Behavioral Therapy, Randomized Controlled Trial, Veterans, Social Rhythms
Brief summary
The purpose of this study is to test the effectiveness of group psychotherapy designed specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily routine.
Detailed description
The purpose of this study is to test the effectiveness of a group psychotherapy designed specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily routine. We will compare two group therapies, one of which has been examined in previous studies for veterans with PTSD. Both group therapies have been shown to reduce symptoms of anxiety and depression in some veterans. However, neither group therapy has been proven to be more effective than treatment as usual for PTSD.
Interventions
BEHAVIORALCognitive Behavioral Social Rhythm Group Therapy
12 weeks, 2h structured group therapy
BEHAVIORALPresent Centered Group Therapy
12 weeks, 2h relatively unstructured group therapy
Sponsors
United States Department of Defense
Southern Arizona VA Health Care System
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Veteran or active duty military personnel * Current posttraumatic stress disorder (PTSD), at least moderate severity * Criterion A exposure to trauma occurring after the age of 18 * Major depressive disorder (MDD), at least moderate severity * Disturbances in sleep (primary insomnia, insomnia related to PTSD, or nightmare disorder) or daily routine
Exclusion criteria
* Current or past bipolar disorder * Current psychotic disorder * Substance abuse/dependence in last 30 days * Uncontrolled serious medical condition or neurological disorder * Currently working an overnight shift * Primary untreated sleep apnea, restless legs syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | post-treatment, at 12 weeks | Hamilton Rating Scale for Depression, 17 item The Hamilton Rating Scale for Depression is an interview assessment of depression symptom severity. Total score range is from 0 (no symptoms of depression) to 52 (maximum symptoms of depression). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD | post-treatment, at 12 weeks | Clinician-Administered PTSD Scale (CAPS), DSM-IV The CAPS is a 17-item interview assessment post-traumatic stress disorder (PTSD) symptom severity. Total score ranges from 0 (no PTSD symptoms) to 136 (maximum PTSD symptoms). |
Countries
United States
Participant flow
Recruitment details
Veterans were recruited from the Southern Arizona VA Health Care System, Mental Health Clinic, September 2009 to July 2011.
Pre-assignment details
115 enrolled, 50 eligible, 7 withdrew prior to randomization (3 time commitment, 2 lost contact, 1 changed mind/unknown, 1 travel distance)
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Behavioral Social Rhythm Group Therapy CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events. | 21 |
| Present Centered Group Therapy PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events. | 22 |
| Total | 43 |
Baseline characteristics
| Characteristic | Cognitive Behavioral Social Rhythm Group Therapy | Present Centered Group Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 22 Participants | 43 Participants |
| Age, Continuous | 45.24 years STANDARD_DEVIATION 13.99 | 51.46 years STANDARD_DEVIATION 12.6 | 48.42 years STANDARD_DEVIATION 13.51 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 4 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 16 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 21 Participants | 22 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 22 |
| serious Total, serious adverse events | 0 / 21 | 0 / 22 |
Outcome results
Primary
Depression
Hamilton Rating Scale for Depression, 17 item The Hamilton Rating Scale for Depression is an interview assessment of depression symptom severity. Total score range is from 0 (no symptoms of depression) to 52 (maximum symptoms of depression).
Time frame: post-treatment, at 12 weeks
Population: CBSRT arm: 18 participants completed 75% of psychotherapy sessions; 20 participants completed study assessment at 12-week post-treatment time point~PCGT arm: 14 participants completed 75% of psychotherapy sessions; 17 participants completed study assessment at 12-week post-treatment time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Social Rhythm Group Therapy | Depression | 20.30 units on a scale | Standard Deviation 6.51 |
| Present Centered Group Therapy | Depression | 19.18 units on a scale | Standard Deviation 5.79 |
Comparison: Analysis must be qualified by small sample size, worse baseline symptom severity in CBSRT arm, and greater levels of attrition in PCGT armp-value: <0.05Mixed Models Analysis
Secondary
PTSD
Clinician-Administered PTSD Scale (CAPS), DSM-IV The CAPS is a 17-item interview assessment post-traumatic stress disorder (PTSD) symptom severity. Total score ranges from 0 (no PTSD symptoms) to 136 (maximum PTSD symptoms).
Time frame: post-treatment, at 12 weeks
Population: CBSRT arm: 18 participants who completed 75% of psychotherapy sessions; 20 participants who completed 12-week post-treatment assessment~PCGT arm: 14 participants who completed 75% of psychotherapy sessions; 17 participants who completed 12-week post-treatment assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Social Rhythm Group Therapy | PTSD | 67.35 units on a scale | Standard Deviation 26.82 |
| Present Centered Group Therapy | PTSD | 62.47 units on a scale | Standard Deviation 24.83 |
Comparison: Analysis must be qualified by small sample size, worse baseline symptom severity in CBSRT arm, and greater levels of attrition in PCGT armp-value: <0.05Mixed Models Analysis