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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

Tracking Information
First Submitted Date  ICMJE April 3, 2019
First Posted Date  ICMJE April 5, 2019
Last Update Posted Date November 21, 2019
Actual Study Start Date  ICMJE December 10, 2018
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psychosocial Adjunctive Treatment for Hypersomnia (PATH)
Official Title  ICMJE Psychosocial Adjunctive Treatment for Hypersomnia (PATH): A Pilot Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Narcolepsy
  • Idiopathic Hypersomnia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Cognitive-Behavior Therapy for Hypersomnia (CBT-H)
  • 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.
    Intervention: Behavioral: Cognitive-Behavior Therapy for Hypersomnia (CBT-H)
Publications * Ong JC, Dawson SC, Mundt JM, Moore C. Developing a cognitive behavioral therapy for hypersomnia using telehealth: a feasibility study. J Clin Sleep Med. 2020 Dec 15;16(12):2047-2062. doi: 10.5664/jcsm.8750.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2019)
35
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2019)
32
Actual Study Completion Date  ICMJE October 7, 2019
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03904238
Other Study ID Numbers  ICMJE STU00207253
185-SR-17 ( Other Grant/Funding Number: American Academy of Sleep Medicine Foundation )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jason Ong, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Northwestern University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP