Clinical trial NCT03904238: Psychosocial Adjunctive Treatment for Hypersomnia (PATH)
Official title: Psychosocial Adjunctive Treatment for Hypersomnia (PATH): A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Narcolepsy
Idiopathic Hypersomnia
Keywords: Hypersomnia
narcolepsy
idiopathic hypersomnia
psychosocial
cognitive-behavior therapy
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Patient Health Questionnaire (PHQ)
timeFrame: Change from Baseline PHQ at 6 weeks (Post-treatment)
Secondary outcomes:
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Self Efficacy Scale
timeFrame: Baseline to post-treatment (6 weeks)
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale
timeFrame: Baseline to post-treatment (6 weeks)
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
timeFrame: Baseline to post-treatment (6 weeks)
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale
timeFrame: Baseline to post-treatment (6 weeks)
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Scale
timeFrame: Baseline to post-treatment (6 weeks)
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
timeFrame: Baseline to post-treatment (6 weeks)
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Phyiscal Function Scale
timeFrame: Baseline to post-treatment (6 weeks)
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Baseline to post-treatment (6 weeks)
measure: Functional Outcomes of Sleep Questionaire (FOSQ)
timeFrame: Baseline to post-treatment (6 weeks)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Center for Circadian and Sleep Medicine, Northwestern University
state: Illinois
Study officials:
References:
citation: 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.