The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse

NCT ID: NCT01987089

Last Updated: 2020-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-15
• Study Completion Date: 2020-03-30

Brief Summary

Insomnia is a highly prevalent disorder in those recovering from alcoholism. It has been associated with anxiety and depressive symptoms, as well as an increased risk of relapse back to the drinking.

Cognitive Behavioral Therapy for Insomnia (CBT-I), a non-pharmacologic approach is the recommended standard of care for insomnia. Some preliminary studies have shown that CBT-I may be efficacious for insomnia during recovery.

The current study proposes to use a standard 8-week CBT-I to treat the insomnia with a post-treatment follow-up at 3- and 6-months (after treatment). Further, it will evaluate if an improvement in the insomnia is associated with an improvement in the underling alcoholism and the daytime functioning. On an exploratory basis, the association of a first-degree family history of alcoholism with the insomnia severity and treatment response will also be evaluated.

Detailed Description

Eligible subjects will be Veterans with alcohol dependence during their first year of recovery, 21-65 years old, with ISI total score of 15 or more, medically and psychiatrically stable, and without dependence on other drugs (with the exception of nicotine and marijuana).

The proposed study will consist of a single-blind trial comparing CBT-I against a behavioral placebo intervention (Quasi-Desensitization Therapy, QDT).

Baseline assessments conducted over a month will comprehensively evaluate for the addiction, psychiatric, sleep and medical disorders, as well as for a family history of alcohol dependence.

Once the subject is seen to be eligible for the study he will be randomized to either the CBT-I or the QDT arm, and treated for the next weeks. The primary outcome measure for insomnia will be the Insomnia Severity Index. The primary outcome measure for alcohol dependence will be the percent days abstinent (on the Time Line Follow Back measure, TLFB), and the daytime symptoms will be assessed using the Short Form-12 item scale (SF-12, for self reported well-being), the Beck Depression Inventory (BDI, for depressive symptoms), and the State Trait Anxiety Inventory (STAI, for anxiety symptoms).

After completion of the treatment phase, subjects will be followed up 3 months and 6 months later, to assess for changes over time in their insomnia, alcohol use, and daytime functioning.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CBT-I

Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician. Session 1 serves as an orientation. No active treatment is delivered at this time. Sessions 2 \& 3 are used to deliver the three main components of the intervention which are Sleep Restriction (SRT), Stimulus Control, and Sleep Hygiene. All but two of the remaining sessions are dedicated to the titration of total sleep time and to ensuring patient adherence. One session (session 5) entails the delivery of a specific form of cognitive therapy. The final session (session 8) is used to engage in a relapse-prevention didactic, i.e., to review first, how insomnia becomes chronic and second, the strategies that are likely to abort an extended episode of insomnia.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Intervention Type: BEHAVIORAL

Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.

QDT

This form of placebo therapy has been commonly used in prior studies investigating behavioral interventions for insomnia. The therapist presents the QDT as a means to eliminate "conditioned arousal," occurring after nocturnal arousal using 8 sessions on a weekly basis. The therapist initially helps the subject to develop a chronological 12-item hierarchy of commonly practiced activities on awakening at night, like opening eyes and clock watching. As a next step, the subject develops 6 imaginable scenes of himself/herself engaged in neutral activities like reading a newspaper. The therapist then helps the subject pair the neutral scenes with the items from the 12-item hierarchy, which is then practiced by the subject 2 hours before bedtime.

Group Type: PLACEBO_COMPARATOR

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Intervention Type: BEHAVIORAL

Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Male and female Veterans between the ages of 21 and 70 years
• DSM IV diagnosis of alcohol dependence over the past year (as determined by the Structured Clinical Interview for DSM-IV Axis I Disorders [SCID-I])
• Self-reported sleep latency or wake time after sleep onset >30 min on three or more nights per week for 1 month and a score of 15 or more on the Insomnia Severity Index (ISI)
• No current alcohol withdrawal symptoms at baseline: CIWA score < 8 (CIWA is the Clinical Institute Withdrawal Assessment scale for alcohol withdrawal signs and symptoms)
• Abstain for at least 4 weeks from heavy drinking, and < 12 months of abstinence from heavy drinking prior to the baseline study assessments, as assessed by subjective report or breathalyzer
• Ability to speak, understand and print in English
• Capacity to give written informed consent

Exclusion Criteria

• DSM-IV criteria for dependence on any other substance including benzodiazepines (and excluding nicotine dependence)
• Patient is currently in alcohol withdrawal as assessed by the Clinical Institute Withdrawal Assessment Scale (CIWA) total score of 8 or more
• A lifetime DSM-IV diagnosis of Bipolar I or II disorder, Schizophrenia, or other psychotic disorder, as determined on the SCID-I, and current (past month) DSM-IV diagnosis of Major Depressive Disorder
• Presence of unstable medical diagnosis e.g. congestive heart failure, leading to interference with sleep, as reported on history, examination, and/or review of clinical chart during baseline assessments
• Current use of any medications that may influence the drinking behavior, e.g. naltrexone or acamprosate
• Evidence of severe cognitive impairment as assessed by the Blessed Orientation-Memory-Concentration (BOMC) test weighted score
• Untreated patients with the diagnosis of moderate-severe obstructive sleep apnea with Total Apnea-Hypopnea Index (AHI-T) of 15 events/hour of sleep
• Subject's inability to give informed consent

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Subhajit Chakravorty, MD

Role: PRINCIPAL_INVESTIGATOR

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Locations

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1IK2CX000855

Identifier Type: NIH

Identifier Source: secondary_id

View Link

01468

Identifier Type: OTHER

Identifier Source: secondary_id

NURA-017-13S

Identifier Type: -

Identifier Source: org_study_id