The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

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.
    

Intervention name(s): Cognitive Behavioral Therapy for Insomnia (CBT-I)
Intervention type(s): Behavioral
Intervention description(s): Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Insomnia; Sleep initiation and maintenance disorder; Alcoholism; Cognitive behavioral therapy for insomnia