The Effect of Family History on Insomnia During Sobriety in Alcoholics

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

• Registration Number: NCT01603381
• Lead Sponsor: Corporal Michael J. Crescenz VA Medical Center

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:

1. to assess for any change in the alcohol consumption indices between the groups after 8 weeks of CBTi,

2. to assess for change in psychiatric symptoms of mood and anxiety across the groups,

3. to assess for differences in insomnia in subjects, with and without a first degree family history of alcohol dependence,

4. to evaluate for any change in impulsivity-related measure with insomnia treatment.

Study Timeline

• Study First Submitted: 2012-02-03
• Study First Submitted QC: 2012-05-18
• Study First Posted: 2012-05-22
• Study Start: 2012-06
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-02
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

Inclusion Criteria

1. Presence of insomnia currently
2. DSM IV diagnosis of alcohol dependence within the past year
3. Not in acute alcohol withdrawal and within a year of sobriety from alcoholism
4. Patients with moderate-severe sleep apnea compliant on their PAP device
5. Can speak, understand and print in English.
6. Is capable of giving written informed consent.

Exclusion Criteria

1. Dependence on psychoactive substance (excluding alcohol, nicotine and cannabis) in the past 12 months, or evidence of chronic opiate use.
2. Unstable/serious psychiatric condition e.g. schizophrenia, bipolar disorder.
3. Unstable or serious medical/neurologic illness
4. Severe cognitive impairment
5. Untreated moderate - severe obstructive sleep apnea

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT-I	Cognitive Behavioral Therapy for Insomnia (CBT-I)	Cognitive Behavioral Therapy for Insomnia

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index total score	8 weeks.	There will be post-treatment follow up at 3 months and 6 months.

Secondary Outcome Measures

Name	Time	Method
Time Line Follow Back measure	8 weeks.	There will be post-study follow-up at 3 months and 6 months also.

Trial Locations

Locations (1)

Philadelphia Veterans Affairs Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States