The Effect of Family History on Insomnia During Sobriety in Alcoholics
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2012
CompletedFirst Posted
Study publicly available on registry
May 22, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedOctober 4, 2016
October 1, 2016
4.1 years
February 3, 2012
October 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Insomnia Severity Index total score
There will be post-treatment follow up at 3 months and 6 months.
8 weeks.
Secondary Outcomes (1)
Time Line Follow Back measure
8 weeks.
Study Arms (2)
CBT-I
EXPERIMENTALCognitive Behavioral Therapy for Insomnia
Monitor Only (M.O.)
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Philadelphia Veterans Affairs Medical Center
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
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.
PMID: 30912860DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Subhajit Chakravorty, M.D.
Corporal Michael J. Crescenz VA Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Physician
Study Record Dates
First Submitted
February 3, 2012
First Posted
May 22, 2012
Study Start
June 1, 2012
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
October 4, 2016
Record last verified: 2016-10