The Effect of Family History on Insomnia During Sobriety in Alcoholics

Corporal Michael J. Crescenz VA Medical Center

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01603381

01257

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

CBT-I

Experimental group

Description:

Cognitive Behavioral Therapy for Insomnia

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Monitor Only (M.O.)

No Intervention group