The Effect of Family History on Insomnia During Sobriety in Alcoholics
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|ClinicalTrials.gov Identifier: NCT01603381|
Recruitment Status : Completed
First Posted : May 22, 2012
Last Update Posted : October 4, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Insomnia||Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Family History on Insomnia During Sobriety in Alcoholics|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Cognitive Behavioral Therapy for Insomnia
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
Behavioral management of insomnia
|No Intervention: Monitor Only (M.O.)|
- Insomnia Severity Index total score [ Time Frame: 8 weeks. ]There will be post-treatment follow up at 3 months and 6 months.
- Time Line Follow Back measure [ Time Frame: 8 weeks. ]There will be post-study follow-up at 3 months and 6 months also.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|