Cognitive Behavioral Therapy for Insomnia in Substance Use Disorders

NCT03208855 | Completed

• 1 other identifier: IRB00117179
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorders; Insomnia

Keywords

Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 6-month follow-up period.

Secondary Outcomes (1)

• Attrition in a substance abuse treatment program.

  Up to 3-month follow-up period

Study Arms (2)

CBT-I

EXPERIMENTAL

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)

Treatment as Usual

NO INTERVENTION

Participants will receive treatment as usual for substance abuse treatment as part of their intensive outpatient treatment of substance use recovery

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I) BEHAVIORAL

8 week 1-hour sessions of group CBT-I with each group including 3-4 men.

Also known as: gCBT-I

CBT-I

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Self-report of Bipolar Disorder
• Self-report of Epilepsy or seizure disorder
• Suicidal ideation
• Acute Alcohol Withdrawal requiring medical attention

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Cornerstone at Helping Up Mission Clinic

Baltimore, Maryland, 21203, United States

Location

Related Publications (1)

• Speed TJ, Hanks L, Turner G, Gurule E, Kearson A, Buenaver L, Smith MT, Antoine D. A comparison of cognitive behavioral therapy for insomnia to standard of care in an outpatient substance use disorder clinic embedded within a therapeutic community: a RE-AIM framework evaluation. Trials. 2022 Nov 28;23(1):965. doi: 10.1186/s13063-022-06885-7.

  PMID: 36443869 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Traci Speed, MD/PHD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 6, 2017
• Study Start: July 31, 2017
• Primary Completion: April 13, 2020
• Study Completion: October 13, 2020
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)