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Completed

NCT Number: NCT03904238

Psychosocial Adjunctive Treatment for Hypersomnia (PATH)

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Circadian and Sleep Medicine, Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Cognitive-Behavior Therapy for Hypersomnia (CBT-H)

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Psychosocial Adjunctive Treatment for Hypersomnia (PATH): A Pilot Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 5, 2019
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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