Cognitive-behavioural conjoint therapy versus prolonged exposure for PTSD in military service members and veterans: results and lessons from a randomized controlled trial.

Military personnel and veterans are at heightened risk for exposure to traumatic events and posttraumatic stress disorder (PTSD), as well as intimate relationship problems associated with PTSD.The purpose of this study was to evaluate the relative efficacy of CBCT and PE in improving intimate relationship functioning in active duty military personnel or veterans and their intimate partners; both conditions were hypothesized to significantly improve PTSD. Method: In this study, 32 military service members or veterans with PTSD and their intimate partners were randomized to receive either Cognitive-Behavioral Conjoint Therapy for PTSD (n = 15; CBCT; [Monson, C. M., & Fredman, S. J. (2012). Cognitive-behavioral conjoint therapy for posttraumatic stress disorder: Harnessing the healing power of relationships. Guilford]), a trauma-focused couple therapy, or Prolonged Exposure (n = 17; PE; [Foa, E. B., Hembree, E. A., Dancu, C. V., Peterson, A. L., Cigrang, J. A., & Riggs, D. S. (2008). Prolonged exposure treatment for combat-related stress disorders - provider's treatment manual [unpublished]. Department of Psychiatry, University of Pennsylvania]), a front-line evidence-based individual treatment for PTSD.There were significant challenges with recruitment and a significant difference in dropout from treatment for the two therapies (65% for PE; 27% for CBCT). Treatment dropout was differentially related to pre-treatment relationship functioning; those with below average relationship functioning had higher dropout in PE compared with CBCT, whereas those with above average relationship functioning did not show differential dropout. In general, CBCT led to relational improvements, but this was not consistently found in PE. Clinician- and self-reported PTSD symptoms improved with both treatments.This study is the first to test a couple or family therapy against a well-established, front-line recommended treatment for PTSD, with expected superiority of CBCT over PE on relationship outcomes. Lessons learned in trial design, including considerations of equipoise, and the effects of differential dropout on trial analyses are discussed. This trial provides further support for the efficacy of CBCT in the treatment of PTSD and enhancement of intimate relationships.

Differential dropout from trial of couple versus individual therapy for PTSD.General pattern of improvements in relationship outcomes in couple therapy for PTSD.PTSD symptoms improved in the individual and couple therapy for PTSD.Lessons learned in trial design, including considerations of equipoise, and the effects of differential dropout by condition on trial analyses are discussed.

Dose-related effects of ketamine for antidepressant-resistant symptoms of posttraumatic stress disorder in veterans and active duty military: a double-blind, randomized, placebo-controlled multi-center clinical trial.

This study tested the efficacy of repeated intravenous ketamine doses to reduce symptoms of posttraumatic stress disorder (PTSD). Veterans and service members with PTSD (n = 158) who failed previous antidepressant treatment were randomized to 8 infusions administered twice weekly of intravenous placebo (n = 54), low dose (0.2 mg/kg; n = 53) or standard dose (0.5 mg/kg; n = 51) ketamine. Participants were assessed at baseline, during treatment, and for 4 weeks after their last infusion. Primary analyses used mixed effects models. The primary outcome measure was the self-report PTSD Checklist for DSM-5 (PCL-5), and secondary outcome measures were the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and the Montgomery Åsberg Depression Rating Scale (MADRS). There were no significant group-by-time interactions for PTSD symptoms measured by the PCL-5 or CAPS-5. The standard ketamine dose ameliorated depression measured by the MADRS significantly more than placebo. Ketamine produced dose-related dissociative and psychotomimetic effects, which returned to baseline within 2 h and were less pronounced with repeated administration. There was no evidence of differential treatment discontinuation by ketamine dose, consistent with good tolerability. This clinical trial failed to find a significant dose-related effect of ketamine on PTSD symptoms. Secondary analyses suggested that the standard dose exerted rapid antidepressant effects. Further studies are needed to determine the role of ketamine in PTSD treatment. ClinicalTrials.gov identifier: NCT02655692.

Testing the role of aerobic exercise in the treatment of posttraumatic stress disorder (PTSD) symptoms in U.S. active duty military personnel: a pilot study.

The purpose of this pilot study was to determine if the efficacy of imaginal exposure for symptoms of posttraumatic stress disorder (PTSD) could be improved by adding aerobic exercise. We hypothesized that aerobic exercise would enhance the efficacy of exposure therapy. Active duty service members with clinically significant symptoms of posttraumatic stress (PTSD Checklist-Stressor-Specific Version, [PCL-S], ≥25) were randomized into one of four conditions: exercise only; imaginal exposure only; imaginal exposure plus exercise; no exercise/no exposure therapy (control). Participants (N = 72) were primarily male, Army, noncommissioned officers ranging in age from 22 to 52. PTSD symptom severity decreased over time (p < .0001); however, there were no significant differences between the experimental conditions. The prediction that imaginal exposure augmented with aerobic exercise would be superior to either imaginal exposure alone or aerobic exercise alone was not supported, suggesting that engaging in exercise and imaginal exposure simultaneously may not be any better than engaging in either activity alone. A better understanding of individually administered and combined exercise and exposure therapy interventions for PTSD is warranted.

Impact of cognitive behavioral therapy for insomnia disorder on sleep and comorbid symptoms in military personnel: a randomized clinical trial.

Study Objectives: To compare the efficacy of cognitive behavioral therapy for insomnia (CBTi) disorder and a Control condition on reducing insomnia and comorbid symptoms in a sample of active duty military personnel. Methods: Randomized clinical trial of 151 active duty US Army personnel at Fort Hood, Texas. Results: This study replicated Original (n = 66) findings (CBTi outperformed Control) in a follow-on sample (n = 85) on diary-assessed sleep efficiency (d = 1.04), total sleep time (d = 0.38), sleep latency (d = -0.93), number of awakenings (d = -0.56), wake time after sleep onset (d = -0.91), sleep quality (d = 1.00), and the Insomnia Severity Index (d = -1.36) in active duty soldiers. CBTi also outperformed Control in the combined sample (N = 151) on four of the five subscales of the Multidimensional Fatigue Inventory (d = -0.32 to -0.96) and the mental health subscale on the Veterans RAND 12-Item Health Survey (d = 0.37). Exploratory analyses also showed CBTi outperformed Control on nicotine (d = -0.22) and caffeine (d = -0.47) use reduction. Significant within-group differences were found for both groups on depression, anxiety, and posttraumatic stress disorder symptoms, but there was no group by time interaction for these symptoms or for use of hypnotics or alcohol. Conclusions: CBTi was an effective treatment for insomnia and comorbid symptoms including daytime fatigue, general mental health, nicotine, and caffeine use. Clinical Trial Registration: Clinicaltrials.gov; Identifier: NCT01549899; "Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia".

Reliability of the Structured Clinical Interview for DSM-5 Sleep Disorders Module.

STUDY OBJECTIVES: To develop and demonstrate interrater reliability for a Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Sleep Disorders (SCISD). METHODS: The SCISD was designed to be a brief, reliable, and valid interview assessment of adult sleep disorders as defined by the DSM-5. A sample of 106 postdeployment active-duty military members seeking cognitive behavioral therapy for insomnia in a randomized clinical trial were assessed with the SCISD prior to treatment to determine eligibility. Audio recordings of these interviews were double-scored for interrater reliability. RESULTS: The interview is 8 pages long, includes 20 to 51 questions, and takes 10 to 20 minutes to administer. Of the nine major disorders included in the SCISD, six had prevalence rates high enough (ie, n ≥ 5) to include in analyses. Cohen kappa coefficient (κ) was used to assess interrater reliability for insomnia, hypersomnolence, obstructive sleep apnea hypopnea (OSAH), circadian rhythm sleep-wake, nightmare, and restless legs syndrome disorders. There was excellent interrater reliability for insomnia (1.0) and restless legs syndrome (0.83); very good reliability for nightmare disorder (0.78) and OSAH (0.73); and good reliability for hypersomnolence (0.50) and circadian rhythm sleep-wake disorders (0.50). CONCLUSIONS: The SCISD is a brief, structured clinical interview that is easy for clinicians to learn and use. The SCISD showed moderate to excellent interrater reliability for six of the major sleep disorders in the DSM-5 among active duty military seeking cognitive behavioral therapy for insomnia in a randomized clinical trial. Replication and extension studies are needed. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Title: Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia; Identifier: NCT01549899; URL: https://clinicaltrials.gov/ct2/show/NCT01549899.

Moving effective treatment for posttraumatic stress disorder to primary care: A randomized controlled trial with active duty military.

INTRODUCTION: Many military service members with PTSD do not receive evidence-based specialty behavioral health treatment because of perceived barriers and stigma. Behavioral health providers in primary care can deliver brief, effective treatments expanding access and reducing barriers and stigma. The purpose of this randomized clinical trial was to determine if a brief cognitive-behavior therapy delivered in primary care using the Primary Care Behavioral Health model would be effective at reducing PTSD and co-occurring symptoms. METHOD: A total of 67 service members (50 men, 17 women) were randomized to receive a brief, trauma-focused intervention developed for the primary care setting called Prolonged Exposure for Primary Care (PE-PC) or a delayed treatment minimal contact control condition. Inclusion criteria were significant PTSD symptoms following military deployment, medication stability, and interest in receiving treatment for PTSD symptoms in primary care. Exclusion criteria were moderate or greater risk of suicide, severe brain injury, or alcohol/substance use at a level that required immediate treatment. Assessments were completed at baseline, posttreatment/postminimal contact control, and at 8-week and 6-month posttreatment follow-up points. Primary measures were the PTSD Symptom Scale-Interview and the PTSD Checklist-Stressor-Specific. RESULTS: PE-PC resulted in larger reduction in PTSD severity and general distress than the minimal contact control. Delayed treatment evidenced medium to large effects comparable to the immediate intervention group. Treatment benefits persisted through the 6-month follow-up of the study. DISCUSSION: PE-PC delivered in integrated primary care is effective for the treatment of PTSD and co-occurring symptoms and may help reduce barriers and stigma found in specialty care settings. (PsycINFO Database Record

Reducing alcohol consumption to minimize weight gain and facilitate smoking cessation among military beneficiaries.

INTRODUCTION: Smoking cessation-related weight gain can have significant negative health and career consequences for military personnel. Alcohol reduction combined with smoking cessation may decrease weight gain and relapse. METHOD: A randomized clinical trial of military beneficiaries compared a standard smoking cessation (i.e., brief informational) intervention (N=159), with a brief motivational smoking cessation intervention that emphasized reduced drinking to lessen caloric intake and minimize weight gain (N=158). RESULTS: Participants who received the motivational intervention were significantly more likely to quit smoking at the 3-month follow-up (p=0.02), but the differences were not maintained at 6 (p=0.18) or 12months (p=0.16). Neither weight change nor alcohol reduction distinguished the 2 groups. Smoking cessation rates at 12months (motivational group=32.91%, informational group=25.79%) were comparable to previous studies, but successful cessation was not mediated by reduced drinking. CONCLUSIONS: Alcohol reduction combined with smoking cessation did not result in decreased weight gain or improved outcomes.

Effect of Group vs Individual Cognitive Processing Therapy in Active-Duty Military Seeking Treatment for Posttraumatic Stress Disorder: A Randomized Clinical Trial.

IMPORTANCE: Cognitive processing therapy (CPT), an evidence-based treatment for posttraumatic stress disorder (PTSD), has not been tested as an individual treatment among active-duty military. Group CPT may be an efficient way to deliver treatment. OBJECTIVE: To determine the effects of CPT on PTSD and co-occurring symptoms and whether they differ when administered in an individual or a group format. DESIGN, SETTING, AND PARTICIPANTS: In this randomized clinical trial, 268 active-duty servicemembers consented to assessment at an army medical center from March 8, 2012, to September 23, 2014, and were randomized to group or individual CPT. Inclusion criteria were PTSD after military deployment and stable medication therapy. Exclusion criteria consisted of suicidal or homicidal intent or psychosis. Data collection was completed on June 15, 2015. Analysis was based on intention to treat. INTERVENTIONS: Participants received CPT (the version excluding written accounts) in 90-minute group sessions of 8 to 10 participants (15 cohorts total; 133 participants) or 60-minute individual sessions (135 participants) twice weekly for 6 weeks. The 12 group and individual sessions were conducted concurrently. MAIN OUTCOMES AND MEASURES: Primary measures were scores on the Posttraumatic Symptom Scale-Interview Version (PSS-I) and the stressor-specific Posttraumatic Stress Disorder Checklist (PCL-S); secondary measures were scores on the Beck Depression Inventory-II (BDI-II) and the Beck Scale for Suicidal Ideation (BSSI). Assessments were completed by independent evaluators masked to treatment condition at baseline and 2 weeks and 6 months after treatment. RESULTS: Among the 268 participants (244 men [91.0%]; 24 women [9.0%]; mean [SD] age, 33.2 [7.4] years), improvement in PTSD severity at posttreatment was greater when CPT was administered individually compared with the group format (mean [SE] difference on the PSS-I, -3.7 [1.4]; Cohen d = 0.6; P = .006). Significant improvements were maintained with the individual (mean [SE] PSS-I, -7.8 [1.0]; Cohen d = 1.3; mean [SE] PCL-S, -12.6 [1.4]; Cohen d = 1.2) and group (mean [SE] PSS-I, -4.0 [0.97]; Cohen d = 0.7; mean [SE] PCL-S, -6.3 [1.4]; Cohen d = 0.6) formats, with no differences in remission or severity of PTSD at the 6-month follow-up. Symptoms of depression and suicidal ideation did not differ significantly between formats. CONCLUSIONS AND RELEVANCE: Individual treatment resulted in greater improvement in PTSD severity than group treatment. Depression and suicidal ideation improved equally with both formats. However, even among those receiving individual CPT, approximately 50% still had PTSD and clinically significant symptoms. In the military population, improving existing treatments such as CPT or developing new treatments is needed. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT02173561.

Treatment of active duty military with PTSD in primary care: A follow-up report.

First-line trauma-focused therapies offered in specialty mental health clinics do not reach many veterans and active duty service members with posttraumatic stress disorder (PTSD). Primary care is an ideal environment to expand access to mental health care. Several promising clinical case series reports of brief PTSD therapies adapted for primary care have shown positive results, but the long-term effectiveness with military members is unknown. The purpose of this study was to determine the long-term outcome of an open trial of a brief cognitive-behavioral primary care-delivered protocol developed specifically for deployment-related PTSD in a sample of 24 active duty military (15 men, 9 women). Measures of PTSD symptom severity showed statistically and clinically significant reductions from baseline to posttreatment that were maintained at the 6-month and 1-year follow-up assessments. Similar reductions were maintained in depressive symptoms and ratings of global mental health functioning.

Weight management using the internet a randomized controlled trial.

BACKGROUND: Most weight-loss research targets obese individuals who desire large weight reductions. However, evaluation of weight-gain prevention in overweight individuals is also critical as most Americans become obese as a result of a gradual gain of 1-2 pounds per year over many years. METHOD: This study evaluated the efficacy of an Internet-based program for weight-loss and weight-gain prevention with a two-group, prospective, randomized controlled trial. A military medical research center with a population of 17,000 active-duty military personnel supplied 446 overweight individuals (222 men; 224 women) with a mean age of 34 years and a mean BMI of 29. Recruitment and study participation occurred 2003-2005 and data were analyzed in 2006. Participants were randomly assigned to receive the 6-month behavioral Internet treatment (BIT, n=227) or usual care (n=224). Change in body weight, BMI, percent body fat, and waist circumference; presented as group by time interactions, were measured. RESULTS: After 6 months, completers who received BIT lost 1.3 kg while those assigned to usual care gained 0.6 kg (F((df=366))=24.17; I<0.001). Results were similar for the intention-to-treat model. BIT participants also had significant changes in BMI (-0.5 vs +0.2 kg/m(2); F((df=366))=24.58); percent body fat (-0.4 vs +0.6%; F((df=366))=10.45); and waist circumference (-2.1 vs -0.4 cm; F((df=366))=17.09); p<0.001 for all. CONCLUSIONS: Internet-based weight-management interventions result in small amounts of weight loss, prevent weight gain, and have potential for widespread dissemination as a population health approach. TRIAL REGISTRATION: NCT00417599.