Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Psychosocial Adjunctive Treatment for Hypersomnia (PATH)

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: NCT03904238
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Jason Ong, Northwestern University

Brief Summary:
Current pharmacological treatments for chronic hypersomnia (narcolepsy, idiopathic hypersomnia) can effectively reduce excessive daytime sleepiness but a high proportion of patients experience depressive symptoms and poor health-related quality of life. Unfortunately, there are currently no psychosocial interventions that directly addresses this issue. Therefore, the overall goal of this project is to gather initial outcome data and work out methodological issues to determine if a future pragmatic clinical trial is warranted.

Condition or disease Intervention/treatment Phase
Narcolepsy Idiopathic Hypersomnia Behavioral: Cognitive-Behavior Therapy for Hypersomnia (CBT-H) Not Applicable

Detailed Description:

Chronic hypersomnia (CH) is a serious and debilitating condition involving persistent excessive daytime sleepiness (EDS) and includes narcolepsy and idiopathic hypersomnia (IH). Currently, pharmacotherapy is the only empirically-validated treatment for reducing EDS in this patient population but the burden of long-term management and adverse effects of the medication lead to poor health-related quality of life (HRQoL) and elevations in depressive symptoms

Evidence-based psychosocial interventions have been developed in other areas to improve HRQoL related to chronic illnesses, such as cancer and chronic pain. These interventions typically involve a package of cognitive and behavioral techniques teaching coping skills (e.g., emotion-focused and problem-focused coping), behavioral management of the chronic illness symptoms (e.g., relaxation for pain management), and other strategies to improve psychosocial functioning (e.g., mindfulness). However, no such interventions have been developed or used for people with CH. Therefore, a major research gap exists for an empirically-validated psychosocial intervention which is aimed directly at improving emotional functioning and HRQoL for people with CH.

The purpose of this project is to develop a cognitive-behavioral treatment for hypersomnia (CBT-H) and conducting a feasibility trial of CBT-H. The specific aims for this project are to: 1) develop and refine a treatment protocol for CBT-H; 2) identify the optimal delivery format of CBT-H; and 3) gather feasibility data on recruitment, retention, and selection criteria for a future clinical trial. The overall significance of this project is to improve the quality of care for people with CH by using a psychosocial intervention with medical management of hypersomnia.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to receive CBT-H in one of two formats: 1) individually or 2) small groups. However, the contents of the intervention are the same.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychosocial Adjunctive Treatment for Hypersomnia (PATH): A Pilot Trial
Actual Study Start Date : December 10, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CBT-H (Individual format)
Individual CBT-H consists of 6 weekly sessions that are conducted one-on-one with a study therapist using live videoconferencing or in-person. Each session is expected to last about 45 to 60 minutes.
Behavioral: Cognitive-Behavior Therapy for Hypersomnia (CBT-H)
The CBT-H intervention consists of 6 weekly sessions that are conducted either individually or in small groups. Each session is expected to last about 45 to 60 minutes and will be delivered a study therapist using live videoconferencing or in-person. The treatment package consists of cognitive and behavioral modules that include education about hypersomnia, coping skills training, emotion regulation regarding the perceived limitations of living with chronic hypersomnia (e.g., "I cannot live a full life because of my illness"), and behavioral techniques using scheduled naps, sleep hygiene, and regularizing sleep schedules at night which are on the current optional recommendations for hypersomnia.

Experimental: CBT-H (Group format)
Group-based CBT-H consists of 6 weekly sessions that are conducted in groups with a study therapist using live videoconferencing or in-person. Each session is expected to last about 45 to 60 minutes. The treatment package consists of the same cognitive and behavioral modules as the individual CBT-H. However, participants are also provided the opportunity to share their experiences and provide peer support in the group format.
Behavioral: Cognitive-Behavior Therapy for Hypersomnia (CBT-H)
The CBT-H intervention consists of 6 weekly sessions that are conducted either individually or in small groups. Each session is expected to last about 45 to 60 minutes and will be delivered a study therapist using live videoconferencing or in-person. The treatment package consists of cognitive and behavioral modules that include education about hypersomnia, coping skills training, emotion regulation regarding the perceived limitations of living with chronic hypersomnia (e.g., "I cannot live a full life because of my illness"), and behavioral techniques using scheduled naps, sleep hygiene, and regularizing sleep schedules at night which are on the current optional recommendations for hypersomnia.




Primary Outcome Measures :
  1. Change in Patient Health Questionnaire (PHQ) [ Time Frame: Change from Baseline PHQ at 6 weeks (Post-treatment) ]
    The PHQ is a 9-item self-report scale of depressive symptoms that has been validated to assess the severity of depression in clinical practice. PHQ-9 cut scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.



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:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females age 18 and older.
  2. Meets criteria for Narcolepsy (Type I or II) or Idiopathic Hypersomnia (IH).
  3. Moderate to severe symptoms of depression.
  4. Established standard care for CH at a sleep clinic.

Exclusion Criteria:

  1. Hypersomnia not of central origin.
  2. Current suicidal ideation or intent.
  3. Uncontrolled medical conditions or physical limitations that require immediate medical treatment that would prevent ability to engage in the treatment protocol.
  4. Inability to engage in the treatment protocol due to a psychiatric or cognitive issue.
  5. Untreated moderate-to-severe sleep-related breathing disorder.
  6. Unable to attend intervention sessions due to accessibility or availability.

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): NCT03904238


Contacts
Layout table for location contacts
Contact: Jason Ong, PhD 312-503-6627 lincstudy@northwestern.edu
Contact: Cameron Moore, BA 312-503-6627 lincstudy@northwestern.edu

Locations
Layout table for location information
United States, Illinois
Center for Circadian and Sleep Medicine, Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Cameron Moore, BA    312-503-6627    lincstudy@northwestern.edu   
Sponsors and Collaborators
Northwestern University

Layout table for additonal information
Responsible Party: Jason Ong, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03904238     History of Changes
Other Study ID Numbers: STU00207253
185-SR-17 ( Other Grant/Funding Number: American Academy of Sleep Medicine Foundation )
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
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 Jason Ong, Northwestern University:
Hypersomnia
narcolepsy
idiopathic hypersomnia
psychosocial
cognitive-behavior therapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Narcolepsy
Disorders of Excessive Somnolence
Hypersomnolence, Idiopathic
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders