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
|Condition or disease||Intervention/treatment||Phase|
|Substance Use Disorders Insomnia||Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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.
- 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.
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
|Contact: Traci J Speed, MD/PHDfirstname.lastname@example.org|
|Contact: Denis Antoine, MDemail@example.com|
|United States, Maryland|
|Cornerstone at Helping Up Mission Clinic||Recruiting|
|Baltimore, Maryland, United States, 21203|
|Contact: Denis Antoine, MD 410-550-2796 ext 112 firstname.lastname@example.org|
|Principal Investigator:||Traci Speed, MD/PHD||Johns Hopkins University|