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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Department of Veterans Affairs
Sponsor:
Collaborators:
University of Pennsylvania
University of Michigan
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01987089
First received: November 12, 2013
Last updated: November 12, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Insomnia
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Insomnia Severity Index - total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Insomnia Severity Index (ISI): This 7-item (0-4 Likert scales) measure yields a total score of 28. The norms for the scale are as follows: 0-7 represents no clinically significant insomnia; 8-14 represents sub threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The scale provides a measure of severity of insomnia (overall), a measure of insomnia subtype, a measure of the diurnal effects of insomnia, and a measure of sleep "satisfaction". The ISI will be completed at baseline and for all the subsequent study-related visits.


Secondary Outcome Measures:
  • Percent Days Abstinent (PDA) on the Time Line Follow back measure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Time Line Follow Back measure (TLFB): The TLFB provides assessment of drinking using a calendar format for the number of standard alcoholic beverages consumed per day. A standard drink, as defined by the National Institutes of Health, is 12 oz of regular beer, 5 oz of regular wine, or 1.5 oz of distilled spirits (e.g. whiskey). Heavy drinking is defined as consumption of > 4 standard drinks in one day or the consumption of 14 standard drinks in one week in males, and > 3 standard drinks a day or more than 7 drinks a week in females. Numerous indices may be derived from the TLFB, including those proposed for the present study: Percent Days Abstinent (PDA), number of drinking days, proportion of drinking days, and proportion of days of heavy drinking.

  • Short Form - 12 item (SF-12) measure [ Time Frame: Baseline, and 8 weeks ] [ Designated as safety issue: No ]
    The SF-12 self-report instrument is a measure of subjective well-being. This instrument yields 2 summary scales and 8-scale profiles. The 8-scale profiles are the General Health, Physical Functioning, Role Functioning (physical), Bodily Pain, Vitality, Role Functioning (emotional), Mental Health, and Social Functioning. The summary scales are the Physical Component Summary (PCS) and Mental Component Summary (MCS). Both of the summary scales range from 0 (indicating the lowest level of health) to 100 (indicating the best level of health).

  • Beck Depression Inventory (BDI - II) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    This 21-item self-report questionnaire assesses for depressive symptoms as well as depressive disorder. Each of the 21 items is rated on a 4-point scale from 0-3, yielding a summary score range of 0-63. The BDI-II total score of 0-13 is consistent with minimal depression, 14-19 with mild depression, 20-28 with moderate depression, and 29-63 with severe depression. The BDI-II will be used to assess for change in minor mood symptoms, as is recommended as part of the research-related assessment for insomnia102 and as has been used in a prior study of CBT-I in recovering alcohol-dependent subjects with insomnia9.

  • State Trait Anxiety Inventory (STAI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The STAI is one of the most widely used instruments assessing for self-reported anxiety symptoms in insomnia research. The STAI measures anxiety as both a current state ("feeling right now") and an enduring trait ("generally feel"), each evaluated with 20 items scored on a scale from 0 (not at all") to 3 ("very much so"). The trait portion of the STAI (STAI-T) is recommended for use in insomnia research studies. The scores of the trait anxiety range from 20 (mild) to 80 (severe). We will use the STAI to assess for trait anxiety symptoms commonly associated with insomnia, which is recommended for the research-related assessment for insomnia and which has been used in a prior study of CBT-I in recovering alcohol-dependent subjects with insomnia.


Estimated Enrollment: 86
Study Start Date: August 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
Placebo Comparator: 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.

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

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female Veterans between the ages of 21 and 65 years;
  • DSM IV diagnosis of alcohol dependence over the past year (as determined by the 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);
  • 1 month and < 12 months of abstinence from alcohol 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 BOMC (Blessed Orientation-Memory-Concentration 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987089

Contacts
Contact: Subhajit Chakravorty, MD (215) 823-5800 ext 4391 Subhajit.Chakravorty@va.gov

Locations
United States, Pennsylvania
Philadelphia VA Medical Center, Philadelphia, PA Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Subhajit Chakravorty, MD    215-823-5800 ext 4391    Subhajit.Chakravorty@va.gov   
Principal Investigator: Subhajit Chakravorty, MD         
Sponsors and Collaborators
University of Pennsylvania
University of Michigan
Investigators
Principal Investigator: Subhajit Chakravorty, MD Philadelphia VA Medical Center, Philadelphia, PA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01987089     History of Changes
Other Study ID Numbers: NURA-017-13S, 1 IK2 CX000855, 01468
Study First Received: November 12, 2013
Last Updated: November 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Insomnia
Sleep initiation and maintenance disorder
Alcoholism
Cognitive behavioral therapy for insomnia

ClinicalTrials.gov processed this record on November 24, 2014