The Effect of Family History on Insomnia During Sobriety in Alcoholics

October 2, 2016 updated by: Subhajit Chakravorty, Corporal Michael J. Crescenz VA Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia Veterans Affairs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT-I
Cognitive Behavioral Therapy for Insomnia
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
Behavioral management of insomnia
No Intervention: Monitor Only (M.O.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index total score
Time Frame: 8 weeks.
There will be post-treatment follow up at 3 months and 6 months.
8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Line Follow Back measure
Time Frame: 8 weeks.
There will be post-study follow-up at 3 months and 6 months also.
8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporal Michael J. Crescenz VA Medical Center

Investigators

  • Principal Investigator: Subhajit Chakravorty, M.D., Corporal Michael J. Crescenz VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

February 3, 2012

First Submitted That Met QC Criteria

May 18, 2012

First Posted (Estimate)

May 22, 2012

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

October 2, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01257

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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