Skip to main content
OpenTrials
Completed

NCT Number: NCT01603381

The Effect of Family History on Insomnia During Sobriety in Alcoholics

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Philadelphia Veterans Affairs Medical Center

Philadelphia, Pennsylvania, 19104, United States

About this study

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:

  • to assess for any change in the alcohol consumption indices between the groups after 8 weeks of CBTi,
  • to assess for change in psychiatric symptoms of mood and anxiety across the groups,
  • to assess for differences in insomnia in subjects, with and without a first degree family history of alcohol dependence,
  • to evaluate for any change in impulsivity-related measure with insomnia treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of insomnia currently
  • DSM IV diagnosis of alcohol dependence within the past year
  • Not in acute alcohol withdrawal and within a year of sobriety from alcoholism
  • Patients with moderate-severe sleep apnea compliant on their PAP device
  • Can speak, understand and print in English.
  • Is capable of giving written informed consent.

Exclusion criteria

  • Dependence on psychoactive substance (excluding alcohol, nicotine and cannabis) in the past 12 months, or evidence of chronic opiate use.
  • Unstable/serious psychiatric condition e.g. schizophrenia, bipolar disorder.
  • Unstable or serious medical/neurologic illness
  • Severe cognitive impairment
  • Untreated moderate - severe obstructive sleep apnea

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Behavioral

Behavioral management of insomnia

Primary outcomes

  1. Insomnia Severity Index total score

    Time frame: 8 weeks.

    There will be post-treatment follow up at 3 months and 6 months.

Secondary outcomes

  1. Time Line Follow Back measure

    Time frame: 8 weeks.

    There will be post-study follow-up at 3 months and 6 months also.

Sponsors and collaborators

Lead sponsor

Corporal Michael J. Crescenz VA Medical Center

Fed

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 22, 2012
Registry last updated
Oct 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.