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

NCT ID: NCT01949389

Last Updated: 2016-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet-based Cognitive Behavioral Therapy for Insomnia

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.

Group Type: EXPERIMENTAL

Internet-based Cognitive Behavioral Therapy for Insomnia

Intervention Type: 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.

Interventions

Internet-based Cognitive Behavioral Therapy for Insomnia

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Connecticut Healthcare System

FED

Sponsor Role: lead

Responsible Party

Robert Rosenheck

Senior Health Serivces Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

VA Connecticut Healthcare System

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

01633

Identifier Type: -

Identifier Source: org_study_id