Psychosocial Adjunctive Treatment for Hypersomnia (PATH)

Narcolepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03904238
• Other study ID #: STU00207253
• Secondary ID: 185-SR-17
• Status: Completed
• Phase: N/A
• Start date: December 10, 2018
• Est. completion date: October 7, 2019

Study information

• Verified date: November 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 7, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Idiopathic Hypersomnia
• Narcolepsy

Intervention

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.

Locations

Country	Name	City	State
United States	Center for Circadian and Sleep Medicine, Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire (PHQ)	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 from Baseline PHQ at 6 weeks (Post-treatment)
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS) Self Efficacy Scale	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.	Baseline to post-treatment (6 weeks)
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale	Measures depressive symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more anxiety symptoms.	Baseline to post-treatment (6 weeks)
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale	Measures anxiety symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more anxiety symptoms.	Baseline to post-treatment (6 weeks)
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale	Measures sleep disturbances using Computer Adaptive Testing (CAT) with higher scores reflecting more sleep disturbance.	Baseline to post-treatment (6 weeks)
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Scale	Measures sleep-related impairment using Computer Adaptive Testing (CAT) with higher scores reflecting worse outcomes.	Baseline to post-treatment (6 weeks)
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale	Measures fatigue using Computer Adaptive Testing (CAT) with higher scores reflecting worse outcomes.	Baseline to post-treatment (6 weeks)
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS) Phyiscal Function Scale	Measures physical function using Computer Adaptive Testing (CAT) with higher scores reflecting better physical function.	Baseline to post-treatment (6 weeks)
Secondary	Epworth Sleepiness Scale (ESS)	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.	Baseline to post-treatment (6 weeks)
Secondary	Functional Outcomes of Sleep Questionaire (FOSQ)	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.	Baseline to post-treatment (6 weeks)