Back to resultsThe Effect of Family History on Insomnia During Sobriety in Alcoholics
Primary Purpose
Insomnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia
Eligibility Criteria
Inclusion Criteria:
- Presence of insomnia currently
- DSM IV diagnosis of alcohol dependence within the past year
- Not in acute alcohol withdrawal and within a year of sobriety from alcoholism
- Patients with moderate-severe sleep apnea compliant on their PAP device
- Can speak, understand and print in English.
- Is capable of giving written informed consent.
Exclusion Criteria:
- Dependence on psychoactive substance (excluding alcohol, nicotine and cannabis) in the past 12 months, or evidence of chronic opiate use.
- Unstable/serious psychiatric condition e.g. schizophrenia, bipolar disorder.
- Unstable or serious medical/neurologic illness
- Severe cognitive impairment
- Untreated moderate - severe obstructive sleep apnea
Sites / Locations
- Philadelphia Veterans Affairs Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CBT-I
Monitor Only (M.O.)
Arm Description
Cognitive Behavioral Therapy for Insomnia
Outcomes
Primary Outcome Measures
Insomnia Severity Index total score
There will be post-treatment follow up at 3 months and 6 months.
Secondary Outcome Measures
Time Line Follow Back measure
There will be post-study follow-up at 3 months and 6 months also.
Full Information
NCT ID
NCT01603381
First Posted
February 3, 2012
Last Updated
October 2, 2016
Sponsor
Corporal Michael J. Crescenz VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01603381
Brief Title
The Effect of Family History on Insomnia During Sobriety in Alcoholics
Official Title
The Effect of Family History on Insomnia During Sobriety in Alcoholics
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporal Michael J. Crescenz VA Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators intend to assess the following:
the efficacy of CBTi in treating insomnia during recovery,
does a family history of alcoholism moderate the insomnia symptoms,
does an improvement in insomnia lead to a decrease in impulsivity.
Detailed Description
The primary goals of this pilot study are the following:
a) to assess for the difference in improvement insomnia, after 8 weeks of treatment with recommended CBTi, in Veterans with alcohol dependence during early recovery,
The secondary goals include the following:
to assess for any change in the alcohol consumption indices between the groups after 8 weeks of CBTi,
to assess for change in psychiatric symptoms of mood and anxiety across the groups,
to assess for differences in insomnia in subjects, with and without a first degree family history of alcohol dependence,
to evaluate for any change in impulsivity-related measure with insomnia treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT-I
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy for Insomnia
Arm Title
Monitor Only (M.O.)
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Intervention Description
Behavioral management of insomnia
Primary Outcome Measure Information:
Title
Insomnia Severity Index total score
Description
There will be post-treatment follow up at 3 months and 6 months.
Time Frame
8 weeks.
Secondary Outcome Measure Information:
Title
Time Line Follow Back measure
Description
There will be post-study follow-up at 3 months and 6 months also.
Time Frame
8 weeks.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of insomnia currently
DSM IV diagnosis of alcohol dependence within the past year
Not in acute alcohol withdrawal and within a year of sobriety from alcoholism
Patients with moderate-severe sleep apnea compliant on their PAP device
Can speak, understand and print in English.
Is capable of giving written informed consent.
Exclusion Criteria:
Dependence on psychoactive substance (excluding alcohol, nicotine and cannabis) in the past 12 months, or evidence of chronic opiate use.
Unstable/serious psychiatric condition e.g. schizophrenia, bipolar disorder.
Unstable or serious medical/neurologic illness
Severe cognitive impairment
Untreated moderate - severe obstructive sleep apnea
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subhajit Chakravorty, M.D.
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philadelphia Veterans Affairs Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30912860
Citation
Chakravorty S, Morales KH, Arnedt JT, Perlis ML, Oslin DW, Findley JC, Kranzler HR. Cognitive Behavioral Therapy for Insomnia in Alcohol-Dependent Veterans: A Randomized, Controlled Pilot Study. Alcohol Clin Exp Res. 2019 Jun;43(6):1244-1253. doi: 10.1111/acer.14030. Epub 2019 Apr 29.
Results Reference
derived
Learn more about this trial
The Effect of Family History on Insomnia During Sobriety in Alcoholics
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