The Effect of Family History on Insomnia During Sobriety in Alcoholics
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effect of Family History on Insomnia During Sobriety in Alcoholics|
- Insomnia Severity Index total score [ Time Frame: 8 weeks. ] [ Designated as safety issue: No ]There will be post-treatment follow up at 3 months and 6 months.
- Time Line Follow Back measure [ Time Frame: 8 weeks. ] [ Designated as safety issue: No ]There will be post-study follow-up at 3 months and 6 months also.
|Study Start Date:||June 2012|
|Study Completion Date:||July 2016|
|Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Cognitive Behavioral Therapy for Insomnia
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
Behavioral management of insomnia
|No Intervention: Monitor Only (M.O.)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603381
|United States, Pennsylvania|
|Philadelphia Veterans Affairs Medical Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Subhajit Chakravorty, M.D.||Corporal Michael J. Crescenz VA Medical Center|