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IIR 11-296 – HSR&D Study

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IIR 11-296
Telemedicine management of veterans with PTSD and chronic insomnia
Samuel T. Kuna MD
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, PA
Funding Period: December 2012 - September 2016

BACKGROUND/RATIONALE:
Most Veterans with PTSD experience chronic insomnia that has independent, negative effects on quality of life and may exacerbate other symptoms of PTSD. Cognitive behavioral therapy for insomnia (CBT-I) is highly efficacious and effective in patients with primary insomnia but the lack of clinicians trained in CBT-I limits Veterans' access to this treatment. Video teleconferencing holds the promise of increasing access to care of Veterans living in rural and remote areas. No previous studies have evaluated the delivery of CBT-I to groups of Veterans with PTSD and chronic insomnia via video teleconferencing.

OBJECTIVE(S):
The primary aim of the study was to determine if Veterans with PTSD and chronic insomnia receiving CBT-I via telemedicine through video teleconferencing have an improvement in insomnia severity, as determined by change in Insomnia Severity Index (ISI) score, that is not clinically inferior to that in Veterans receiving in-person CBT-I. Improvements in ISI score were compared between patients receiving CBT-I through video teleconferencing and through the in-person setting and between the CBT-I groups and a non-active control group. We hypothesized that six months following CBT-I treatment, the mean change in ISI score from baseline in Veterans receiving CBT-I by video teleconferencing would be no more than 1.67 smaller than the reference treatment, i.e., Veterans receiving in-person CBT-I. Since the expected mean difference in the active control group is -6.5, 1.67 represents approximately 74% of retained efficacy for the test treatment. The observed lower bound was used to determine the maximum reduction in efficacy consistent with the observed data.

METHODS:
Participants (N=114) were recruited at the Corporal Michael J. Crescenz VA Medical Center (CMCVAMC) and its community-based outpatient clinics (CBOC). Veterans received the interventions at the VA site where they received their primary care.

Eligibility criteria were as follows: at least 18 years of age; diagnosis of PTSD based on current DSM-IV-TR criteria for PTSD as determined by the Clinician Administered PTSD Scale (CAPS); Insomnia Severity Index score > 14, the commonly used threshold for clinical insomnia, with self-reported duration of insomnia >6 months; ability to read and speak English. Individuals were excluded for the following reasons: untreated sleep apnea (defined as an AHI>15 events per hour) as determined by home sleep testing; a clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 2 months; evidence of substance dependence during the preceding twelve months or "at risk" drinking behavior over the past month; bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia and other psychotic disorders as determined by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID) questionnaire; and prominent current suicidal or homicidal ideation. Veterans on treatment for a sleep disorder other than insomnia for at least 2 months were eligible to participate. This included patients with sleep apnea on positive airway pressure treatment. Individuals currently receiving psychotherapy were permitted to continue this treatment but their provider was asked to try not to initiate any new psychotherapeutic interventions for insomnia (e.g. CBT-I) or PTSD (e.g. prolonged exposure) until study participation was completed.

CBT-I was administered in a group format by trained clinical psychologists. Psychologists were trained in the CBT-I manual created for dissemination in the VA. CBT-I was delivered in 6 weekly, 90-minute sessions. All video teleconferencing treatment sessions were delivered over the existing secure system at CMCVAMC and its CBOC facilities. A non-active control group received in-person sleep education in a group setting. Participants were assessed at baseline, and 2 weeks, 3 months and 6 months following the end of treatment.
Of the 114 randomized, 55 completed the study. The primary analysis used mixed effects models for longitudinal data with clustered observations. The primary hypothesis was tested by using analyses of covariance to construct least squares estimates of the (adjusted) group differences in mean values along with their confidence intervals (CI). If the lower bound exceeded the non-inferiority threshold, then the null hypotheses of inferiority could be rejected at =0.05. For the change in ISI outcome, baseline ISI was included as an a priori covariate. We computed the lower bound of the non-inferiority confidence bound at 2 weeks, 3 months and 6 months following the end of treatment. The 3 month assessment was the primary endpoint.

FINDINGS/RESULTS:
114 Veterans with current PTSD on the Clinician Administered PTSD Scale and Insomnia Severity Index (ISI) score were enrolled. Participants with sleep apnea on home testing had to be on PAP treatment for at least 3 months. Participants completed the following self-report measures: ISI, Nightmare Frequency Questionnaire (NFQ), Nightmare Distress Questionnaire (NDQ), Short Form-12 Health Survey (SF-12), PTSD Checklist (PCL), and Work and Social Adjustment Scale (WSAS). Linear regressions examined the extent to which insomnia and nightmares predicted measures of functioning, with age as a covariate.

Enrolled participants had the following characteristics: mean age 55.6 12.3 yr; 91.4% males; 42.2% African American. Mean scores at baseline were: PCL- 61.8 12.3; ISI- 20.6 4.2; NDQ- 26.2 7.5; SF-12 Physical component (PCS)- 35.8 10.3; SF-12 Mental component- 41.9 9.3; and WSAS- 23.4 10.7. On the NFQ, nightmares were reported to have occurred 117.4 93.6 nights out of the past year with a total number of nightmares of 131.9 148.8. Higher ISI score was associated with poorer PCS (p<0.05) and WSAS (p<0.001) scores. Higher NDQ score was associated with poorer WSAS score (p<0.05).

In the baseline assessment, both insomnia and nightmare distress were associated with impaired work and social functioning, but only insomnia was related to poorer physical quality of life. Surprisingly, neither was associated with mental quality of life. These results demonstrate that chronic sleep disturbance in veterans with PTSD is associated with impaired daily functioning and quality of life.

In the Intent-to-Treat (ITT) analyses, the mean change in total ISI score was 6.48 for in person CBT-I (n=46) and 4.45 for telehealth CBT-I (n=49). This difference in efficacy between groups was less than the pre-specified margin for non-inferiority, indicating that CBT-I delivered by telehealth was not clinically inferior to in-person treatment. For the per protocol analyses, the mean change in total ISI score was 6.68 for in person CBT-I (n=25) and 5.13 for telehealth CBT-I (n=23), which again was less than the margin.

IMPACT:
The confirmation of the hypotheses and the information gained from the formative evaluation will provide the evidence needed to justify clinical implementation of this telemedicine model for CBT-I delivery to Veterans with PTSD. This will significantly increase access to treatment, particularly for Veterans residing in remote and rural settings, and decrease treatment-related costs.

PUBLICATIONS:

Journal Articles

  1. Gehrman P, Shah MT, Miles A, Kuna S, Godleski L. Feasibility of Group Cognitive-Behavioral Treatment of Insomnia Delivered by Clinical Video Telehealth. Telemedicine journal and e-health : the official journal of the American Telemedicine Association. 2016 Dec 1; 22(12):1041-1046.
Conference Presentations

  1. Kuna ST. New clinical pathways to diagnose and manage sleep apnea. Paper presented at: Sleep Respiratory Medicine Annual Guangzhou International Congress; 2014 Jun 1; Guangzhou, China.
  2. Kuna ST. Update in home sleep studies. Paper presented at: Advances in Diagnosis and Treatment of Sleep Apnea and Snoring Annual Conference; 2014 Feb 14; San Francisco, CA.
  3. Kuna ST. CPAP adherence. Paper presented at: Advances in Diagnosis and Treatment of Sleep Apnea and Snoring Annual Conference; 2014 Feb 14; San Francisco, CA.
  4. Kuna ST. Cardiovascular consequences of OSA. Paper presented at: Advances in Diagnosis and Treatment of Sleep Apnea and Snoring Annual Conference; 2014 Feb 14; San Francisco, CA.
  5. Kuna ST. New technological approaches to a major health problem. Paper presented at: Nordic Lung Annual Congress; 2013 Jun 15; Reykjavik, Iceland.
  6. Kuna ST. Incorporating telehealth and communications technology into sleep medicine practice. Paper presented at: Pennsylvania Sleep Society Annual Meeting; 2013 May 4; Grantville, PA.
  7. Kuna ST. Is in-laboratory polysomnography on life support? Are home sleep studies the future of sleep medicine? Paper presented at: American Thoracic Society New York State Chapter Annual Scientific Assembly; 2013 Feb 1; Valhalla, NY.


DRA: Mental, Cognitive and Behavioral Disorders
DRE: Treatment - Observational, Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: PTSD
MeSH Terms: none