Telemedicine Management of Chronic Insomnia

NCT01686438 | Completed Results DMC

• 1 other identifier: IIR 11-296
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Initiation and Maintenance Disorders; Post-Traumatic Stress Disorders

Keywords

cost effectiveness; patient satisfaction

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Insomnia Severity Index Score

  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.

  Baseline to 3 months

Secondary Outcomes (13)

• Change From Baseline PTSD Checklist-Military (PCL-M) Scores

  baseline to 3 months

• Change From Baseline Pittsburgh Sleep Quality Index (PSQI) Scores

  baseline to 3 months

• Change From Baseline in Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)

  baseline to 3 months

• Change From Baseline in Nightmare Distress Questionnaire Scores

  baseline to 3 month

• Change From Baseline Medical Outcomes Study Short Form-12 (SF-12) Mental Component Score

  baseline to 3 months

Study Arms (2)

CBT-I delivery by video teleconferencing

EXPERIMENTAL

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

In-person CBT-I delivery

ACTIVE COMPARATOR

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

Interventions

Cognitive behavioral therapy for insomnia BEHAVIORAL

A behavioral modification program consisting of 6 clinic sessions focused on sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring.

Also known as: CBT-I

CBT-I delivery by video teleconferencing; In-person CBT-I delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Pennsylvania: collaborator

Study Sites (1)

Philadelphia VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 27286369 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Stress Disorders, Post-Traumatic; Patient Satisfaction

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Samuel T. Kuna
• Organization: Crescenz VA Medical Center

Samuel.Kuna@va.gov

215-823-4400

Study Officials

• Samuel T. Kuna, MD

  Philadelphia VA Medical Center, Philadelphia, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2012
• First Posted: September 18, 2012
• Study Start: April 1, 2013
• Primary Completion: November 30, 2016
• Study Completion: November 30, 2016
• Last Updated: August 29, 2019
• Results First Posted: August 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)