Telemedicine Management of Veterans With PTSD and Chronic Insomnia (VIP)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Sleep Initiation and Maintenance Disorders Post-Traumatic Stress Disorders |
Behavioral: Cognitive behavioral therapy for insomnia |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Telemedicine Management of Veterans With PTSD and Chronic Insomnia |
- Change in Insomnia Severity Index score [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
- Wrist Actigraphy with sleep diary [ Time Frame: 6 months ] [ Designated as safety issue: No ]Objective measure of sleep pattern
- PTSD Checklist-Military (PCL-M) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Measure of PTSD severity
- SF-12 [ Time Frame: 6 months ] [ Designated as safety issue: No ]General quality of life assessment
- Work and Social Adjustment Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Pittsburgh Sleep Quality Index [ Time Frame: 6 months ] [ Designated as safety issue: No ]Subjective measure of sleep quality
- Working Alliance Inventory [ Time Frame: 2-8 weeks ] [ Designated as safety issue: No ]
- Charleston Psychiatric Outpatient Satisfaction Scale-VA [ Time Frame: 2-8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 225 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CBT-I delivery by video teleconferencing
Groups of participants will receive a cognitive behavioral therapy for insomnia program delivered by a trained psychologist using video teleconferencing.
|
Behavioral: Cognitive behavioral therapy for insomnia
A behavioral modification program consisting of 6 clinic sessions focused on sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring.
Other Name: CBT-I
|
|
Active Comparator: In-person CBT-I delivery
Groups of participants will receive a cognitive behavioral therapy for insomnia (CBT-I) program by meeting in-person with a trained psychologist.
|
Behavioral: Cognitive behavioral therapy for insomnia
A behavioral modification program consisting of 6 clinic sessions focused on sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring.
Other Name: CBT-I
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations| Contact: Samuel T Kuna, MD | (215) 823-5800 ext 4400 | samuel.kuna@va.gov |
| Contact: Philip R Gehrman, PhD | (215) 746-3578 | philip.gehrman@va.gov |
| United States, Pennsylvania | |
| VA Medical Center, Philadelphia | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Samuel T Kuna, MD (215) 823-5800 ext 4400 samuel.kuna@va.gov | |
| Contact: Philip R Gehrman, PhD (215) 746-3578 philip.gehrman@va.gov | |
| Sub-Investigator: Jennifer Gala True, PhD | |
| Sub-Investigator: Philip R. Gehrman, PhD | |
| Principal Investigator: Samuel T. Kuna, MD | |
| Principal Investigator: | Samuel T. Kuna, MD | VA Medical Center, Philadelphia |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01686438 History of Changes |
| Other Study ID Numbers: | IIR 11-296 |
| Study First Received: | September 6, 2012 |
| Last Updated: | February 13, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
cost effectiveness patient satisfaction |
Additional relevant MeSH terms:
|
Sleep Initiation and Maintenance Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Mental Disorders Anxiety Disorders |
ClinicalTrials.gov processed this record on May 23, 2013