Telemedicine Management of Chronic Insomnia (VIP)

This study is currently recruiting participants.
Verified January 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01686438
First received: September 6, 2012
Last updated: January 30, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in Insomnia Severity Index score [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686438

Contacts
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

Locations
United States, Pennsylvania
VA Medical Center, Philadelphia 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         
Sub-Investigator: Richard J. Ross, MD PhD         
Principal Investigator: Samuel T. Kuna, MD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
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: January 30, 2014
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 April 16, 2014