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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03904238
Recruitment Status : Completed
First Posted : April 5, 2019
Last Update Posted : November 21, 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 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
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : October 7, 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. 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.


Secondary Outcome Measures :
  1. Patient Reported Outcomes Measurement Information System (PROMIS) Self Efficacy Scale [ Time Frame: Baseline to post-treatment (6 weeks) ]
    Measures general self-efficacy, self-efficacy for managing emotions, self-efficacy for managing social interactions, self-efficacy for managing symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting better self-efficacy.

  2. Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale [ Time Frame: Baseline to post-treatment (6 weeks) ]
    Measures depressive symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more anxiety symptoms.

  3. Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale [ Time Frame: Baseline to post-treatment (6 weeks) ]
    Measures anxiety symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more anxiety symptoms.

  4. Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale [ Time Frame: Baseline to post-treatment (6 weeks) ]
    Measures sleep disturbances using Computer Adaptive Testing (CAT) with higher scores reflecting more sleep disturbance.

  5. Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Scale [ Time Frame: Baseline to post-treatment (6 weeks) ]
    Measures sleep-related impairment using Computer Adaptive Testing (CAT) with higher scores reflecting worse outcomes.

  6. Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale [ Time Frame: Baseline to post-treatment (6 weeks) ]
    Measures fatigue using Computer Adaptive Testing (CAT) with higher scores reflecting worse outcomes.

  7. Patient Reported Outcomes Measurement Information System (PROMIS) Phyiscal Function Scale [ Time Frame: Baseline to post-treatment (6 weeks) ]
    Measures physical function using Computer Adaptive Testing (CAT) with higher scores reflecting better physical function.

  8. Epworth Sleepiness Scale (ESS) [ Time Frame: Baseline to post-treatment (6 weeks) ]
    The ESS consists of eight questions rated from 0 to 3, with higher scores indicating greater likelihood of falling asleep. Total scores of 10 or greater reflect excessive daytime sleepiness.

  9. Functional Outcomes of Sleep Questionaire (FOSQ) [ Time Frame: Baseline to post-treatment (6 weeks) ]
    The FOSQ assesses the impact of sleepiness on daily behaviors and quality of life. It is comprised of 30 items divided into five subscales: activity level, vigilance, intimate and sexual relationships, general productivity, and social outcome. Items are rated from 1 to 4, with higher score reflecting better functioning.



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.


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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


Locations
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United States, Illinois
Center for Circadian and Sleep Medicine, Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
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Responsible Party: Jason Ong, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03904238    
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: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Narcolepsy
Disorders of Excessive Somnolence
Hypersomnolence, Idiopathic
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders