The Effect of Family History on Insomnia During Sobriety in Alcoholics

This study is currently recruiting participants.
Verified May 2013 by Philadelphia Veterans Affairs Medical Center
Sponsor:
Collaborator:
VISN-4 MIRECC, Philadelphia Veterans Affairs Medical Center
Information provided by (Responsible Party):
Subhajit Chakravorty, Philadelphia Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01603381
First received: February 3, 2012
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Effect of Family History on Insomnia During Sobriety in Alcoholics

Further study details as provided by Philadelphia Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Insomnia Severity Index total score [ Time Frame: 8 weeks. ] [ Designated as safety issue: No ]
    There will be post-treatment follow up at 3 months and 6 months.


Secondary Outcome Measures:
  • Time Line Follow Back measure [ Time Frame: 8 weeks. ] [ Designated as safety issue: No ]
    There will be post-study follow-up at 3 months and 6 months also.


Estimated Enrollment: 24
Study Start Date: February 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.)

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 and without a family history of 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 the risk-taking and other impulsivity-related measures with insomnia treatment.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603381

Locations
United States, Pennsylvania
Philadelphia Veterans Affairs Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Elliott B Sturgis    215-823-5800 ext 3405      
Sponsors and Collaborators
Philadelphia Veterans Affairs Medical Center
VISN-4 MIRECC, Philadelphia Veterans Affairs Medical Center
Investigators
Principal Investigator: Subhajit Chakravorty, M.D. Philadelphia Veterans Affairs Medical Center
  More Information

No publications provided

Responsible Party: Subhajit Chakravorty, Staff Physician, Philadelphia Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01603381     History of Changes
Other Study ID Numbers: 01257
Study First Received: February 3, 2012
Last Updated: May 13, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014