Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

The Effect of Family History on Insomnia During Sobriety in Alcoholics

This study has been completed.
Information provided by (Responsible Party):
Subhajit Chakravorty, Corporal Michael J. Crescenz VA Medical Center Identifier:
First received: February 3, 2012
Last updated: October 2, 2016
Last verified: October 2016

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

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

Further study details as provided by Corporal Michael J. Crescenz VA 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.

Enrollment: 22
Study Start Date: June 2012
Study Completion Date: July 2016
Primary Completion Date: July 2016 (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 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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Male
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01603381

United States, Pennsylvania
Philadelphia Veterans Affairs Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Corporal Michael J. Crescenz VA Medical Center
Principal Investigator: Subhajit Chakravorty, M.D. Corporal Michael J. Crescenz VA Medical Center
  More Information

Responsible Party: Subhajit Chakravorty, Staff Physician, Corporal Michael J. Crescenz VA Medical Center Identifier: NCT01603381     History of Changes
Other Study ID Numbers: 01257 
Study First Received: February 3, 2012
Last Updated: October 2, 2016
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders processed this record on October 25, 2016