Back to resultsPiloting an Internet-based Therapy for Insomnia in a Population of Veterans With Substance Use Disorders
Primary Purpose
Chronic Insomnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet-based Cognitive Behavioral Therapy for Insomnia
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Insomnia
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
Sites / Locations
- VA Connecticut Healthcare System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Internet-based Cognitive Behavioral Therapy for Insomnia
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01949389
First Posted
September 5, 2013
Last Updated
December 11, 2015
Sponsor
VA Connecticut Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT01949389
Brief Title
Piloting an Internet-based Therapy for Insomnia in a Population of Veterans With Substance Use Disorders
Official Title
Piloting an Internet-based Therapy for Insomnia in a Population of Veterans With Substance Use Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Connecticut Healthcare System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet-based Cognitive Behavioral Therapy for Insomnia
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Internet-based Cognitive Behavioral Therapy for Insomnia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insomnia Severity Index (Total), Change From Baseline to Follow-up
Description
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.
Time Frame
pre-intervention, intervention completion (expected average of 7 weeks)
Title
Completion of All 7 Modules of the Intervention
Description
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.
Time Frame
on average 7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
12. IPD Sharing Statement
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Piloting an Internet-based Therapy for Insomnia in a Population of Veterans With Substance Use Disorders
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