N/A
N=63
The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse
Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT01987089 ↗Enrolled (actual)
63
Serious AEs
15.9%
Results posted
Aug 2020
Primary outcome: Primary: Change in Insomnia Severity Index - Total Score — -10.71; -8.84; -8.51; -9.30 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Behavioral Therapy for Insomnia (CBT-I) (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Insomnia Severity Index - Total Score |
-10.71; -8.84; -8.51; -9.30; -6.89; -7.29 | — |
| PRIMARY Change in Percent Days Abstinent (PDA) on the Time Line Follow Back Measure |
0.56; 0.67; 0.51; 0.61; 0.48; 0.62 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01987089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.