Clinical trial NCT01987089: The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse
Official title: The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Sleep initiation and maintenance disorder
Alcoholism
Cognitive behavioral therapy for insomnia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Pennsylvania
name: University of Michigan
First posted: 2013-11-19
Enrollment: 63
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)
* Positive urine drug screen for opioids, cocaine, or amphetamine (positive screen for Tetra Hydro Cannabinol is not considered an exclusion criteria)
* 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

Primary outcomes:
measure: Change in Insomnia Severity Index - Total Score
timeFrame: 8 weeks, 3 months post-treatment, and 6 months post-treatment
measure: Change in Percent Days Abstinent (PDA) on the Time Line Follow Back Measure
timeFrame: 8 weeks, 3 months post-treatment and 6-months post-treatment
Secondary outcomes:
Other outcomes:
measure: Change in PCS From the Short Form - 12 Item (SF-12) Measure
timeFrame: 8 weeks, 3 months post-treatment, and 6 months post-treatment
measure: Change in MCS From the Short Form - 12 Item (SF-12) Measure
timeFrame: 8 weeks, 3 months post-treatment, and 6 months post-treatment
Locations:
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
state: Pennsylvania
Study officials:
affiliation: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
name: Subhajit Chakravorty, MD
role: PRINCIPAL_INVESTIGATOR
References: