Piloting an Internet-based Therapy for Insomnia in a Population of Veterans With Substance Use Disorders

NCT01949389 | Completed Results

• 1 other identifier: 01633
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study is to examine the feasibility of implementing an internet-based treatment for insomnia among veterans with substance use disorders, some with co-morbid serious mental illness, and to develop potential methods to support and encourage veterans while they self-administer this treatment. Our hypotheses are that the implementation of an internet-based therapy will be feasible and that a method of support can be devised, and tested in the future.

Conditions

Chronic Insomnia

Outcome Measures

Primary Outcomes (2)

• Insomnia Severity Index (Total), Change From Baseline to Follow-up

  Insomnia Severity Index (Total) following completion of the intervention (expected average of 7 weeks) The Insomnia Severity Index is a self-report seven-item measure that targets the subjective symptoms and functional consequences of insomnia as well as the degree of concerns or distress caused by those difficulties, and corresponds to the diagnostic criteria of insomnia. Scores range from 0-28, higher scores indicate more severe insomnia, and scores ≥15 suggest moderate to severe insomnia.

  pre-intervention, intervention completion (expected average of 7 weeks)

• Completion of All 7 Modules of the Intervention

  Participants will be followed for the duration of the intervention (7 individual modules, completed weekly, for an expected average of 7 weeks). Outcome measure will be characterized as the number completing all 7 modules of the program (dichotomous variable). The intervention is a 7-week, self-administered course accessed via the Internet that includes instruction on psycho-education, stimulus control, relaxation training, sleep restriction, medication tapering, cognitive distortions, and mindfulness integrated into each module. Homework is assigned after each module. Participants are instructed to complete the sleep diary included in the program daily while participating in the program.

  on average 7 weeks

Study Arms (1)

Internet-based Cognitive Behavioral Therapy for Insomnia

EXPERIMENTAL

This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.

Behavioral: Internet-based Cognitive Behavioral Therapy for Insomnia

Interventions

Internet-based Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.

Internet-based Cognitive Behavioral Therapy for Insomnia

Eligibility Criteria

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

You may qualify if:

• Inability to sleep within 30 minutes of going to bed or awakening during the night for 30 minutes for greater than or equal to 3 days per week
• Above Criteria occurring every week for greater than or equal to 3 months
• At least one symptom of daytime impairment: (reduced motivation, sleepiness, fatigue, lack of concentration, performance at home, work, social life, relationships impaired)
• Able to provide valid consent
• Willing to participate in an internet-based cognitive behavioral therapy for insomnia
• English speaking

You may not qualify if:

• Self-reported or provider diagnosed sleep apnea or related nighttime respiratory problem, restless legs syndrome or related nighttime movement disorder
• Acute psychiatric decompensation requiring inpatient admission or emergency department services within the last month (suicidality, homicidally, mania, psychotic decompensation)
• Current treatment or treatment within the last month for opiate addiction with methadone maintenance or buprenorphine.
• Has a conservator E. Shift work interfering with the establishment of regular sleep patterns F. Previous or ongoing cognitive behavioral therapy for insomnia

Sponsors & Collaborators

• VA Connecticut Healthcare System: lead

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Eric Hermes
• Organization: VA Connecticut Healthcare system

eric.hermes@va.gov

203 932 5711

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Health Serivces Investigator

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 24, 2013
• Study Start: October 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 13, 2016
• Results First Posted: January 5, 2015

Record last verified: 2015-12

Locations

US (1)