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

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Sleep initiation and maintenance disorder, Alcoholism, Cognitive behavioral therapy for insomnia

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CBT-I

QDT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Insomnia Severity Index - Total Score
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.
Change in Percent Days Abstinent (PDA) on the Time Line Follow Back Measure
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). Numerous indices may be derived from the TLFB, such as the Percent Days Abstinent (PDA) proposed in this study. The PDA is derived as the percentage of days an individual reports being abstinent from alcohol within a given assessment time period.

Secondary Outcome Measures

Full Information

First Posted
November 12, 2013
Last Updated
August 6, 2020
Sponsor
VA Office of Research and Development
Collaborators
University of Pennsylvania, University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01987089
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 15, 2014 (Actual)
Primary Completion Date
May 23, 2019 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of Pennsylvania, University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Sleep initiation and maintenance disorder, Alcoholism, Cognitive behavioral therapy for insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT-I
Arm Type
Experimental
Arm Description
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.
Arm Title
QDT
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Intervention Description
Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
Primary Outcome Measure Information:
Title
Change in Insomnia Severity Index - Total Score
Description
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.
Time Frame
8 weeks, 3 months post-treatment, and 6 months post-treatment
Title
Change in Percent Days Abstinent (PDA) on the Time Line Follow Back Measure
Description
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). Numerous indices may be derived from the TLFB, such as the Percent Days Abstinent (PDA) proposed in this study. The PDA is derived as the percentage of days an individual reports being abstinent from alcohol within a given assessment time period.
Time Frame
8 weeks, 3 months post-treatment and 6-months post-treatment
Other Pre-specified Outcome Measures:
Title
Change in PCS From the Short Form - 12 Item (SF-12) Measure
Description
The Physical Component Summary (PCS) scale has a range from 0 (indicating the lowest level of health) to 100 (indicating the best level of health).
Time Frame
8 weeks, 3 months post-treatment, and 6 months post-treatment
Title
Change in MCS From the Short Form - 12 Item (SF-12) Measure
Description
The Mental Component Summary (MCS) scale has a range from 0 (indicating the lowest level of health) to 100 (indicating the best level of health).
Time Frame
8 weeks, 3 months post-treatment, and 6 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subhajit Chakravorty, MD
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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