Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive Behavioral Therapy for Insomnia in Substance Use Disorders (gCBTI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208855
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Insomnia Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy for Insomnia in Substance Use Disorders at an Urban Residential Recovery Program
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: CBT-I
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
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
8 week 1-hour sessions of group CBT-I with each group including 3-4 men.
Other Name: gCBT-I

No Intervention: Treatment as Usual
Participants will receive treatment as usual for substance abuse treatment as part of their intensive outpatient treatment of substance use recovery



Primary Outcome Measures :
  1. Improvement in sleep. [ Time Frame: Up to 6-month follow-up period. ]
    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 :
  1. Attrition in a substance abuse treatment program. [ Time Frame: Up to 3-month follow-up period ]
    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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208855


Contacts
Layout table for location contacts
Contact: Traci J Speed, MD/PHD 4105507985 speed@jhmi.edu
Contact: Denis Antoine, MD 667-208-8069 antoine@jhmi.edu

Locations
Layout table for location information
United States, Maryland
Cornerstone at Helping Up Mission Clinic Recruiting
Baltimore, Maryland, United States, 21203
Contact: Denis Antoine, MD    410-550-2796 ext 112    antoine@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
Layout table for investigator information
Principal Investigator: Traci Speed, MD/PHD Johns Hopkins University
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03208855    
Other Study ID Numbers: IRB00117179
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Cognitive Behavioral Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Initiation and Maintenance Disorders
Substance-Related Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Chemically-Induced Disorders