The Effect of Family History on Insomnia During Sobriety in Alcoholics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBT-I

Cognitive Behavioral Therapy for Insomnia

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Intervention Type BEHAVIORAL

Behavioral management of insomnia

Monitor Only (M.O.)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive Behavioral Therapy for Insomnia (CBT-I)

Behavioral management of insomnia

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No