A Randomized Controlled Trial of Cognitive Behavioral Social Rhythm Group Therapy for Male Veterans with PTSD, Major Depressive Disorder, and Sleep Problems Patricia Haynes,1,2 Monica Kelly,2,1,3 Sairam Parthasarathy,1,2 & Richard Bootzin3 1Southern Arizona VA Healthcare System, 2College of Medicine, University of Arizona, 3Department of Psychology, University of Arizona Introduction Therapies Summary of Findings Sleep problems are highly prevalent in both Posttraumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD) Sleep symptoms may precede and exacerbate both MDD1 and PTSD2 PTSD treatments often do not address sleep symptoms completely3,4 Group therapies for PTSD may not be as efficacious as individual therapies. A large, multicenter RCT found that Present Centered Group Therapy (PCGT) had comparable outcomes to Trauma Focused Exposure Group Therapy, with less attrition.5 Cognitive Behavioral Therapy for Insomnia (CBTi) is efficacious in a group format6 CBTi has lower attrition rates (0-8%) than exposure therapies (~25%) Adjunctive, group therapies may improve PTSD exposure therapy outcomes.7 We developed Cognitive Behavioral Social Rhythm Therapy (CBSRT) as a potential adjunctive, group therapy to CBT for PTSD for veterans with PTSD and MDD (a population with worse psychopathology and treatment outcomes8) Open-trial results indicated that veterans receiving CBSRT have significant improvements in sleep, PTSD, and depression.9 Despite randomization, individuals in CBSRT had significantly worse baseline symptom severity measures than individuals in PCGT, complicating interpretation of findings. Sleep outcomes: During the treatment and follow-up periods, the rates of change in sleep efficiency in CBSRT v. PCGT were significantly different (see graph). In both CBSRT and PCGT, there were significant reductions in sleep onset latency and number of awakenings over the treatment period; this improvement slowed in the follow-up period. From baseline to 6 Month FU, there were few qualitative differences in TST or WASO. Psychiatric outcomes: Both groups improved over time on PTSD and depression outcomes. There were no significant differences between groups. Both groups had >10 point change on CAPS, indicating clinically significant improvement on PTSD symptoms. As expected, individuals in both groups had significant levels of residual symptoms. Cognitive Behavioral Social Rhythm Group Therapy (CBSRT) Present Centered Group Therapy (PCGT) Duration 12 week, once per week 2 hours Modality Group, manualized Format Structured, 1st hour homework review, 2nd hour new material Relatively unstructured, guided by group process needs Model Social Rhythm Hypothesis14 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. Yalom-based Process Group Model15 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. Therapist Goals To collaboratively increase the frequency and consistency of daily behaviors and empirically refute thoughts that may be impede goal attainment. To develop positive group cohesion and the atmosphere of safety and trust. Results Parameter Estimates (and Standard Errors) for Growth Models Examining the Rate of Change x Condition in Symptom Measures Over the Course of Treatment and Through 6 Month Follow-Up Conclusions SE TIB TST WASO SOL No. Awakes B Intercept 64.45*** 3.24 504.03*** 21.46 333.37*** 21.54 47.44*** 10.78 75.70*** 11.64 2.88*** 0.30 Condition 12.01* 4.58 -11.80 30.29 44.94 30.39 2.12 15.19 -41.81* 16.37 -0.10 0.42 Time 0.73** 0.27 -6.36*** 1.70 -2.03 1.64 -0.49 0.76 -1.90** 0.69 -0.08** 0.02 Condition x Time -0.89* 0.40 3.71 2.56 -0.89 2.47 1.05 1.14 1.24 1.04 0.05 0.04 PostTx Time -0.75* 0.36 9.36*** 2.32 4.16ᵗ 2.24 0.78 1.03 2.46* 0.94 0.09** 0.03 Condition x PostTx Time 1.18* 0.55 -6.77ᵗ 3.53 0.10 3.41 -2.07 1.58 -1.98 1.44 -0.07 CBSRT and PCGT appear to produce comparable psychiatric and sleep outcomes (SOL and number of awakenings). As compared to PCGT: CBSRT is associated with faster improvements on sleep efficiency CBSRT is associated with fewer therapy drop-outs Given the lower attrition rate, CBSRT may be a valuable, adjunctive group therapy option for individuals with PTSD and MDD. Research is necessary to test whether CBSRT improves exposure therapy outcomes. Active mental health treatments (such as PCGT) may have positive effects on sleep that may rival behavioral sleep treatments, over time. Results are consistent with previous studies indicating that Vietnam Veterans that are VA Users may have limited treatment responsiveness5,16 Secondary and objective sleep outcome analyses are pending, as are analysis of therapist fidelity, patient adherence, and adequate dosing issues, which may affect overall findings Results must be qualified by small sample size / low power to detect < large effects Hypotheses The purpose of this study was to test whether group CBSRT is superior to PCGT for sleep and psychiatric outcomes in veterans with PTSD, Depression, and sleep problems. A compound symmetry variance matrix was used to model the error variance. PCGT is the reference condition. ᵗp < .10, *p < .05, **p < .01, ***p < .001 Methods Design Double-blind, behavioral RCT comparing CBSRT to PCGT, an active attention control psychotherapy Recruitment Southern Arizona VA Healthcare System Measures Diagnosis: Structured Clinical Interview DSM-IV10 Sleep: Daily Sleep Diary11 PTSD: Clinician Administered PTSD Scale (CAPS)12 Depression: Hamilton Depression Rating Scale (HamD)13 Statistical Analyses Mixed modeling with intent-to-treat approach Participants References 43 male veterans (21 CBSRT, 22 PCGT) Randomization stratified by military era (44% Vietnam, 26% OEF/OIF, 30% Other) No differences in groups on age or ethnicity M Age = 48.42 Yrs (SD = 13.51 Yrs) 56% Caucasian, 23% Hispanic, 7% African Americian, 7% American Indian, 7% Other Exclusion criteria Age < 18 or > 65 Shift work, moderate to severe primary sleep disorders (as determined by PSG), alteration in medications, current substance abuse (< 30 days), uncontrolled medical illness, severe traumatic brain injury/neurological disorder Ford & Kamerow DB. (1989). JAMA, 262 Mellman TA, et al. (2002). Am J Psychiatry, 159 Zayfert & DeViva (2004). J Trauma Stress., 17 Galovski et al. (2009). J Trauma Stress, 22 Schnurr et al. (2003). Arch Gen Psychiatry, 60 Bastien et al. (2004). J Consult Clin Psychol, 72 Cloitre et al. (2002), J Consult Clin Psychol, 70 Holtzheimer et al. (2005). Am J Psychiatry, 162 Haynes et al. (2009). Sleep (Abstract), 32 Spitzer et al. (1992). Arch Gen Psychiatry, 49 Buysse DJ et al. (2006).Sleep, 29 Weathers et al. (2001). Depress Anxiety, 13 Hamilton (1960). J Neurol, Neurosurg Psychiatry, 23 Ehlers et al. (1988). Arch Gen Psychiatry, 45 Yalom (2005). Theory and Practice of Group Psychotherapy Frueh et al. (2000). Clin Psychol Rev, 20 Acknowledgements CAPS B SE Intercept 76.65*** 4.59 Condition -5.25 6.39 Time -0.76* 0.32 Condition x Time 0.39 0.45 HamD B SE Intercept 23.30*** 1.23 Condition -2.37 1.72 Time 0.21ᵗ 0.11 Condition x Time 0.1 0.17 This project was supported by Department of Defense (Grant #W81XWH-08-2-0121). CBSRT was associated with fewer therapy dropouts (χ2 = 2.75, p < .10). Only 14% of the CBSRT group (n = 3) attended less than 75% sessions versus PCGT, where 36% of the sample (n = 8) attended less than 75% of sessions.