Cognitive Behavioral Therapy for Insomnia in Substance Use Disorders (gCBTI)
Primary Purpose
Substance Use Disorders, Insomnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use Disorders focused on measuring Cognitive Behavioral Therapy
Eligibility Criteria
Inclusion Criteria:
- Males > 18 years of age
- Active substance use disorder of any type
- Enrolled in the Cornerstone at Helping Up Mission clinic for less than 3 weeks
- ISI > 8
- Report either latency to sleep onset > 30 minutes or > 2 awakenings/night or > 15 min duration or wake after sleep onset (WASO) time > 30 minutes
- Insomnia symptom frequency self-reported as > 3 night/week for > 1 month
Exclusion Criteria:
- Self-report of Bipolar Disorder
- Self-report of Epilepsy or seizure disorder
- Suicidal ideation
- Acute Alcohol Withdrawal requiring medical attention
Sites / Locations
- Cornerstone at Helping Up Mission Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CBT-I
Treatment as Usual
Arm Description
Participants will receive 8 1-hour sessions of group Cognitive Behavioral Therapy for insomnia as part of their intensive outpatient treatment of substance use recovery
Participants will receive treatment as usual for substance abuse treatment as part of their intensive outpatient treatment of substance use recovery
Outcomes
Primary Outcome Measures
Improvement in sleep.
Participants in both study arms will record subjective sleep measures via self-report sleep diary. They will also complete the Insomnia Severity Index (ISI)) at both pre-and post-treatment and over 6-month follow-up period.
Secondary Outcome Measures
Attrition in a substance abuse treatment program.
Attrition rates for the SUDs treatment program will be compared between the CBT-I and the treatment as usual group at 3-month follow-up.
Full Information
NCT ID
NCT03208855
First Posted
June 28, 2017
Last Updated
January 28, 2022
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT03208855
Brief Title
Cognitive Behavioral Therapy for Insomnia in Substance Use Disorders
Acronym
gCBTI
Official Title
Cognitive Behavioral Therapy for Insomnia in Substance Use Disorders at an Urban Residential Recovery Program
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
April 13, 2020 (Actual)
Study Completion Date
October 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Substance Use Disorders (SUDs) and insomnia are major public health concerns, and each are independently linked to reduced quality of life, disability, and high healthcare costs. Insomnia, characterized by difficulty initiating or maintaining sleep, or nonrestorative sleep, is prevalent in 10% of the general population and is co-morbid in 70% of patients with SUDs. Primary insomnia and SUDs are chronic, unremitting diseases and have a complex bidirectional relationship. Insomnia symptoms may predate the onset of SUDs and may explain high prevalence of self-treatment. Insomnia may also be a direct effect of intoxication, withdrawal, or abstinence from the substance of abuse. Subjective and objective measures of sleep disruption have been shown in various stages of abuse and recovery. Insomnia is the most well documented predictor of substance use relapse. Treatment specifically targeting chronic insomnia is essential for improved clinical outcomes. Although, chronic insomnia is a well-established, modifiable risk factor, to our knowledge, there are no interdisciplinary residential treatment programs that specifically treat chronic insomnia during acute SUDs treatment. We propose that improved treatment of insomnia as part of a comprehensive reinforcement-based outpatient treatment program will provide an efficient and cost effective opportunity to improve standard outpatient SUD. Converging evidence suggests that prophylactic CBT-I during SUD treatment may have short and long-term efficacy for sleep, and improve attrition. In the proposed study, patients with co-morbid SUDs and insomnia will engage in an 8-week group CBT-I (gCBT-I) program in addition to receiving treatment as usual for SUDs. This study may provide new hope to effectively treat insomnia in SUD and lead to a new standardization of outpatient care. We hypothesize that a CBT-I intervention can be implemented as part of an evidence-based SUD treatment program within a residential facility.
Detailed Description
Substance use disorders (SUDs) are a leading cause of global disease burden with significant epidemiological and economic consequences. Sleep disturbances (i.e., difficulty initiating or maintaining sleep) are nearly ubiquitous in individuals with SUDs and may arise from direct effects of the substance or from withdrawal of the substance. Sleep disturbances are reported in up to 70% of individuals entering both detoxification and early recovery programs and may persist for months to years during abstinence. Objective and subjective measures of sleep disturbances are among the best predictors of relapse. Treatment of insomnia (i.e., difficulty initiating or maintaining sleep, with significant daytime impairment) during early recovery may improve relapse rates. Insomnia is a modifiable risk factor and responds to psychological interventions. Given the abuse potential of many medications utilized for sleep disturbances and the likelihood of drug-drug interactions over the course of detoxification, a non-pharmacological approach to insomnia remains promising. To date, few studies have evaluated non-pharmacological approaches to insomnia during early substance abuse recovery. One study has evidenced improved self-reported sleep quality in men who were assigned to 2 weeks of daily progressive muscle relaxation training. Robust evidence indicates that cognitive behavioral therapy for insomnia (CBT-I) is effective, and in fact is first line treatment for primary insomnia. A preponderance of randomized controlled trials of CBT-I in co-morbid populations suggests it is efficacious to address insomnia in context of ongoing medical and psychiatric illnesses. Despite the possibility that treating insomnia may improve relapse and attrition rates, and evidence that CBT-I is efficacious in improving sleep, there is a dearth of empirical data regarding the prophylactic benefit of initiating CBT-I as part of acute abstinence treatment. This study aims to test the feasibility of implementing a non-pharmacological insomnia intervention for individuals at the Cornerstone clinic at the Helping Up Mission, a residential SUD residential recovery program for men in Baltimore, MD. Participants will be recruited from the Cornerstone clinic, an accredited behavioral health clinic directed by Johns Hopkins faculty and staff, which provides evidence-based SUD treatment to residents of the Helping Up Mission. CBT-I will be incorporated into the outpatient reinforcement-based SUD treatment. The investigators hypothesize that implementation of CBT-I during early SUD recovery is feasible and will lead to improved sleep parameters and improved clinical outcomes compared with those receiving treatment as usual (TAU). The investigators propose a proof of concept study which would first demonstrate feasibility of administering CBT-I for individuals residing in a men's homeless shelter, and will further evaluate the short- and long-term efficacy of CBT for insomnia in individuals with SUDs. This investigation will provide important and novel information regarding potential psychological interventions that may be incorporated into evidence-based SUD treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Insomnia
Keywords
Cognitive Behavioral Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT-I
Arm Type
Experimental
Arm Description
Participants will receive 8 1-hour sessions of group Cognitive Behavioral Therapy for insomnia as part of their intensive outpatient treatment of substance use recovery
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Participants will receive treatment as usual for substance abuse treatment as part of their intensive outpatient treatment of substance use recovery
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Other Intervention Name(s)
gCBT-I
Intervention Description
8 week 1-hour sessions of group CBT-I with each group including 3-4 men.
Primary Outcome Measure Information:
Title
Improvement in sleep.
Description
Participants in both study arms will record subjective sleep measures via self-report sleep diary. They will also complete the Insomnia Severity Index (ISI)) at both pre-and post-treatment and over 6-month follow-up period.
Time Frame
Up to 6-month follow-up period.
Secondary Outcome Measure Information:
Title
Attrition in a substance abuse treatment program.
Description
Attrition rates for the SUDs treatment program will be compared between the CBT-I and the treatment as usual group at 3-month follow-up.
Time Frame
Up to 3-month follow-up period
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males > 18 years of age
Active substance use disorder of any type
Enrolled in the Cornerstone at Helping Up Mission clinic for less than 3 weeks
ISI > 8
Report either latency to sleep onset > 30 minutes or > 2 awakenings/night or > 15 min duration or wake after sleep onset (WASO) time > 30 minutes
Insomnia symptom frequency self-reported as > 3 night/week for > 1 month
Exclusion Criteria:
Self-report of Bipolar Disorder
Self-report of Epilepsy or seizure disorder
Suicidal ideation
Acute Alcohol Withdrawal requiring medical attention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Traci Speed, MD/PHD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cornerstone at Helping Up Mission Clinic
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Cognitive Behavioral Therapy for Insomnia in Substance Use Disorders
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