Narcolepsy Clinical Trial
Official title:
Psychosocial Adjunctive Treatment for Hypersomnia (PATH): A Pilot Trial
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.
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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| Status | Clinical Trial | Phase | |
|---|---|---|---|
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||
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||
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