The Effect of Family History on Insomnia During Sobriety in Alcoholics

• Sponsor: Corporal Michael J. Crescenz VA Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01603381
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)	N/A

Detailed Description

The primary goals of this pilot study are the following:

1. 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 Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Family History on Insomnia During Sobriety in Alcoholics
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

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.)

Outcome Measures

Primary Outcome Measures

1. Insomnia Severity Index total score [8 weeks.]

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

Secondary Outcome Measures

1. Time Line Follow Back measure [8 weeks.]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes 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

Locations

	Site	City	State	Country	Postal Code
1	Philadelphia Veterans Affairs Medical Center	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Corporal Michael J. Crescenz VA Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Subhajit Chakravorty, Staff Physician, Corporal Michael J. Crescenz VA Medical Center
• ClinicalTrials.gov Identifier: NCT01603381
• Other Study ID Numbers: 01257
• First Posted: May 22, 2012
• Last Update Posted: Oct 4, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Oct 4, 2016