Clinical trial NCT01686438: Telemedicine Management of Chronic Insomnia
Official title: Telemedicine Management of Veterans With PTSD and Chronic Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Post-Traumatic Stress Disorders
Keywords: cost effectiveness
patient satisfaction
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Pennsylvania
First posted: 2012-09-18
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insomnia is commonly present in Veterans with post-traumatic stress disorder (PTSD). Treatment of insomnia with a specialized type of psychotherapy has been shown to be more effective than treatment with medications. Unfortunately, few psychologists are trained to provide this treatment, limiting Veterans' access to care, especially those Veterans in remote and rural areas. This project will evaluate the ability to deliver this psychotherapy to groups of Veterans by video teleconferencing. Groups of Veterans with PTSD and chronic insomnia will receive the psychotherapy treatment either by meeting in-person with the psychologist or by the psychologist delivering the treatment by video teleconferencing. Finding that video teleconferencing is a cost effective way to deliver this treatment could add an important new component to the care of Veterans with PTSD that provides an alternative to medications.

Detailed description: Objectives(s): The investigators are conducting a randomized, controlled trial of Veterans with PTSD and chronic insomnia to determine if cognitive behavioral therapy for insomnia (CBT-I) administered by video teleconferencing is not clinically inferior to in-person treatment in terms of improvement in insomnia symptoms. Secondary aims are 1) comparing the differences in cost and quality-adjusted life years between the treatment delivery approaches and 2) determining the effectiveness of CBT-I on functional outcomes, sleep quality, and non-sleep-related PTSD symptoms. The investigators are also conducting a patient- and provider-focused formative evaluation of CBT-I delivery by video teleconferencing to assess potential barriers to its widespread implementation.

Research Design: This prospective randomized controlled non-inferiority study will determine if Veterans with PTSD and chronic insomnia receiving CBT-I by 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. Differences in cost and quality-adjusted life years (QALY) between groups will also be compared.

Methodology: Veterans with PTSD and chronic insomnia receiving their primary care at community-based outpatient clinics (CBOC) affiliated with the Philadelphia VAMC are be randomized to receive one of the following interventions in a group setting at their CBOC: 1) a manual-based CBT-I program delivered via video teleconferencing, 2) the CBT-I program delivered in-person, and 3) in-person delivery of sleep hygiene education, a known active control intervention. Participants are assessed at baseline, and 2 weeks and every 3 months following the intervention. The primary outcome measure in Aim 1 is the change in the Insomnia Severity Index (ISI) score at 6 months following intervention. Non-inferiority analysis will be used to compare the effectiveness of the two delivery methods, with a pre-specified margin. Results will be ascertained via intent to treat and per-protocol procedures. The investigators hypothesize that the change in ISI score following CBT-I by video teleconferencing will not be clinically inferior to that following in-person delivery. In Aim 2, VA and non-VA total healthcare costs are being collected to test whether average cost is lower for Veterans receiving CBT-I by video teleconferencing versus in-person care. Preference is being assessed by the EuroQol and Health Utilities Index 2. Differences in the ratio of cost and quality-adjusted life years saved between CBT-I by video teleconferencing and in-person encounter will be compared to test the hypothesis that video teleconferencing will have lower cost and equivalent outcomes. Aim 3 is assessing the effect of CBT-I on functional outcomes (Short Form-12, Work and Social Adjustment Scale), sleep quality (Pittsburgh Sleep Quality Index, sleep diary and wrist actigraphy), and PTSD severity (the non-sleep component of the PTSD Checklist-Military). The investigators hypothesize that these functional outcomes and sleep quality measures will improve following each method of CBT-I delivery and that CBT-I will improve non-sleep-related PTSD severity. The formative evaluation of the telemedicine delivery of CBT-I in Aim 4 is using qualitative (targeted focus groups with participants and therapist interviews) and quantitative measures (Work Alliance Inventory, Treatment Credibility Scale, attrition) that will help guide future implementation of CBT-I by video teleconferencing

Anticipated Findings: The investigators believe these results will demonstrate that: 1) Veterans in both CBT-I groups will have similar improvement in functional outcomes, and 2) treatment delivery by video teleconferencing will be more cost effective than in-person care. These findings should lead to wider acceptance of video teleconferencing, thereby increasing patient access to care and reducing treatment costs.

Eligibility criteria: Inclusion Criteria:

Veterans will have to meet the following inclusion criteria in order to be enrolled in this RCT:

* Men and women at least 18 years of age.
* Meet 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 (assessment instruments and therapy will be available only in English)

Exclusion Criteria:

Veterans will be excluded from participation if they meet any of the following exclusion criteria:

* Unable or unwilling to provide informed consent.
* Unwilling to participate in supervised group sessions at the community based outpatient clinic
* No telephone access or inability to return for follow-up testing.
* Individuals with an untreated sleep disorder \[e.g., obstructive sleep apnea (apnea-hypopnea index 15 events/hr), periodic limb movement disorder (10 leg movements/hr of sleep with arousals), central sleep apnea ( 50% of apneas are central), Cheyne-Stokes respiration, obesity hypoventilation syndrome, and narcolepsy\].
* 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. Evidence of "at risk" drinking behavior over the past month. Namely for men: more than 4 drinks on a given night, drinking on more than 3 nights a week, or more than 14 total drinks in a week; for women: more than 3 drinks in a given night, drinking on more than 3 nights a week, or more than 7 total drinks in a week.
* Individuals with bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia and other psychotic disorders as determined by the SCID questionnaire. A concurrent anxiety disorder or depressive disorder diagnosis will be allowed.
* Individuals with prominent current suicidal or homicidal ideation. This will be assessed by the clinical psychologist administering the SCID and CAPS. In cases of prominent current suicidal or homicidal ideation appropriate safety measures will be taken. Following stabilization, Veterans who continue to be interested in participating in the study may be re-assessed.
* Unable to perform tests due to inability to communicate verbally, inability to read and write; less than a 5th grade reading level; visual, hearing or cognitive impairment (e.g., previous head injury).

Primary outcomes:
measure: Change From Baseline in Insomnia Severity Index Score
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Change From Baseline PTSD Checklist-Military (PCL-M) Scores
timeFrame: baseline to 3 months
measure: Change From Baseline Pittsburgh Sleep Quality Index (PSQI) Scores
timeFrame: baseline to 3 months
measure: Change From Baseline in Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)
timeFrame: baseline to 3 months
measure: Change From Baseline in Nightmare Distress Questionnaire Scores
timeFrame: baseline to 3 month
measure: Change From Baseline Medical Outcomes Study Short Form-12 (SF-12) Mental Component Score
timeFrame: baseline to 3 months
measure: Change From Baseline in Medical Outcomes Study Short Form-12 (SF-12) Physical Component Score
timeFrame: baseline to 3 months
measure: Change From Baseline in Work and Social Adjustment Scale Scores
timeFrame: baseline to 3 months
measure: Working Alliance Inventory - Short Revised (WAI-SR) - Task Formation Scores at 8 Weeks
timeFrame: 2-8 weeks
measure: Charleston Psychiatric Outpatient Satisfaction Scale-VA Scores at 8 Weeks
timeFrame: 2-8 weeks
measure: Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 1 Scores
timeFrame: baseline to 3 months, scores converted to yearly
measure: Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 2 Scores
timeFrame: baseline to 3 months (converted to yearly)
measure: Working Alliance Inventory - Short Revised (WAI-SR) - Bond Formation at 8 Weeks
timeFrame: 2-8 weeks
measure: Working Alliance Inventory - Short Revised (WAI-SR) - Goal Formation at 8 Weeks
timeFrame: 2-8 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Philadelphia VA Medical Center, Philadelphia, PA
state: Pennsylvania
Study officials:
affiliation: Philadelphia VA Medical Center, Philadelphia, PA
name: Samuel T. Kuna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gehrman P, Shah MT, Miles A, Kuna S, Godleski L. Feasibility of Group Cognitive-Behavioral Treatment of Insomnia Delivered by Clinical Video Telehealth. Telemed J E Health. 2016 Dec;22(12):1041-1046. doi: 10.1089/tmj.2016.0032. Epub 2016 Jun 10.