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The Effect of Family History on Insomnia During Sobriety in Alcoholics

The Effect of Family History on Insomnia During Sobriety in Alcoholics

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01603381
Enrollment
22
Registered
2012-05-22
Start date
2012-06-30
Completion date
2016-07-31
Last updated
2016-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

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.

Interventions

BEHAVIORALCognitive Behavioral Therapy for Insomnia (CBT-I)

Behavioral management of insomnia

Sponsors

Corporal Michael J. Crescenz VA Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Insomnia Severity Index total score8 weeks.There will be post-treatment follow up at 3 months and 6 months.

Secondary

MeasureTime frameDescription
Time Line Follow Back measure8 weeks.There will be post-study follow-up at 3 months and 6 months also.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026