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Telemedicine Management of Chronic Insomnia (VIP)

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ClinicalTrials.gov Identifier: NCT01686438
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : August 29, 2019
Last Update Posted : August 29, 2019
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE September 6, 2012
First Posted Date  ICMJE September 18, 2012
Results First Submitted Date  ICMJE February 7, 2019
Results First Posted Date  ICMJE August 29, 2019
Last Update Posted Date August 29, 2019
Actual Study Start Date  ICMJE April 1, 2013
Actual Primary Completion Date November 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
Change From Baseline in Insomnia Severity Index Score [ Time Frame: Baseline to 3 months ]
Self-report questionnaire used widely to assess presence of insomnia and its severity. Scores range from 0-28. Higher scores indicate increasing severity of insomnia.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2012)
Change in Insomnia Severity Index score [ Time Frame: Baseline and 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • Change From Baseline PTSD Checklist-Military (PCL-M) Scores [ Time Frame: baseline to 3 months ]
    Self-administered validated questionnaire measuring PTSD severity. Scores range from 17-85. Higher scores indicate higher severity of symptoms.
  • Change From Baseline Pittsburgh Sleep Quality Index (PSQI) Scores [ Time Frame: baseline to 3 months ]
    Self-administered validated questionnaire measuring subjective sleep quality. Scores range from 0-21. Higher score indicates worse sleep quality. Total score < 5 is associated with good sleep quality.
  • Change From Baseline in Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A) [ Time Frame: baseline to 3 months ]
    Measure of the sleep and dream disturbances often associated with PTSD. Scores range from 0-21. A higher score indicates higher frequency of disruptive nocturnal behaviors. Total score ≥ 4 can be used to indicate PTSD.
  • Change From Baseline in Nightmare Distress Questionnaire Scores [ Time Frame: baseline to 3 month ]
    Measure of intensity of the distress associated with a nightmare. Scores range from 0-52. Higher score indicates increased nightmare distress.
  • Change From Baseline Medical Outcomes Study Short Form-12 (SF-12) Mental Component Score [ Time Frame: baseline to 3 months ]
    Self-administered validated general health-related quality of life questionnaire to assess functional outcome. Scores range from 0 to 100. Higher scores indicate higher health function.
  • Change From Baseline in Medical Outcomes Study Short Form-12 (SF-12) Physical Component Score [ Time Frame: baseline to 3 months ]
    self-administered validated health related quality of life questionnaire to assess functional outcomes. Scores range from 0 to 100. Higher scores indicate higher health function.
  • Change From Baseline in Work and Social Adjustment Scale Scores [ Time Frame: baseline to 3 months ]
    A self-report scale of functional impairment attributable to an identified problem. Scores range from 0 - 40. Higher scores indicate increasing functional impairment.
  • Working Alliance Inventory - Short Revised (WAI-SR) - Task Formation Scores at 8 Weeks [ Time Frame: 2-8 weeks ]
    The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.
  • Charleston Psychiatric Outpatient Satisfaction Scale-VA Scores at 8 Weeks [ Time Frame: 2-8 weeks ]
    Self administered questionnaire of person's satisfaction with care. Total scores range from 13 to 65, with higher scores indicating higher patient satisfaction. Scores reported from session 5.
  • Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 1 Scores [ Time Frame: baseline to 3 months, scores converted to yearly ]
    Measure of nightmare frequency in number of nights with nightmares per year, scores converted to yearly.
  • Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 2 Scores [ Time Frame: baseline to 3 months (converted to yearly) ]
    Self-administered measure of nightmare frequency in actual number of nightmares experienced over a 3 month period, and converted to yearly
  • Working Alliance Inventory - Short Revised (WAI-SR) - Bond Formation at 8 Weeks [ Time Frame: 2-8 weeks ]
    The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.
  • Working Alliance Inventory - Short Revised (WAI-SR) - Goal Formation at 8 Weeks [ Time Frame: 2-8 weeks ]
    The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2012)
  • Wrist Actigraphy with sleep diary [ Time Frame: 6 months ]
    Objective measure of sleep pattern
  • PTSD Checklist-Military (PCL-M) [ Time Frame: 6 months ]
    Measure of PTSD severity
  • SF-12 [ Time Frame: 6 months ]
    General quality of life assessment
  • Work and Social Adjustment Scale [ Time Frame: 6 months ]
  • Pittsburgh Sleep Quality Index [ Time Frame: 6 months ]
    Subjective measure of sleep quality
  • Working Alliance Inventory [ Time Frame: 2-8 weeks ]
  • Charleston Psychiatric Outpatient Satisfaction Scale-VA [ Time Frame: 2-8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telemedicine Management of Chronic Insomnia
Official Title  ICMJE Telemedicine Management of Veterans With PTSD and Chronic Insomnia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep Initiation and Maintenance Disorders
  • Post-Traumatic Stress Disorders
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Cognitive behavioral therapy for insomnia
  • 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.
    Intervention: Behavioral: Cognitive behavioral therapy for insomnia
Publications * 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. Epub 2016 Jun 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2019)
114
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2012)
225
Actual Study Completion Date  ICMJE November 30, 2016
Actual Primary Completion Date November 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01686438
Other Study ID Numbers  ICMJE IIR 11-296
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE University of Pennsylvania
Investigators  ICMJE
Principal Investigator: Samuel T. Kuna, MD Philadelphia VA Medical Center, Philadelphia, PA
PRS Account VA Office of Research and Development
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP