Trial Outcomes & Findings for Piloting an Internet-based Therapy for Insomnia in a Population of Veterans With Substance Use Disorders (NCT NCT01949389)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

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

Results posted on

2016-01-13

Participant Flow

100 Individuals were recruited between October 2013 and May 2014.

A single subject completed informed consent procedures and signed the informed consent document, but then was found not to meet exclusion criteria on review of the medical record. The individual was disenrolled.

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	51
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Internet-based Cognitive Behavioral Therapy for Insomnia n=51 Participants 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: 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.
Age, Continuous	52.2 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Race/Ethnicity, Customized White	27 participants n=5 Participants
Race/Ethnicity, Customized African American	19 participants n=5 Participants
Race/Ethnicity, Customized Other Race/Ethnicity	5 participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants

PRIMARY outcome

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

Population: The number of individuals provided access to the program and reporting baseline and follow-up data

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.

Outcome measures

Outcome measures
Measure	Internet-based Cognitive Behavioral Therapy for Insomnia n=45 Participants 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: 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.
Insomnia Severity Index (Total), Change From Baseline to Follow-up	6.3 units on a scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: on average 7 weeks

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.

Outcome measures

Outcome measures
Measure	Internet-based Cognitive Behavioral Therapy for Insomnia n=51 Participants 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: 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.
Completion of All 7 Modules of the Intervention	21 participants

Adverse Events

Internet-based Cognitive Behavioral Therapy for Insomnia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eric Hermes

VA Connecticut Healthcare system

Phone: 203 932 5711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place