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

Chronic Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949389
• Other study ID #: 01633
• Status: Completed
• Phase: N/A
• First received: September 5, 2013
• Last updated: December 11, 2015
• Start date: October 2012
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: VA Connecticut Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Insomnia
• Substance-Related Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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	No