Psychosocial Adjunctive Treatment for Hypersomnia (PATH)
2 other identifiers
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2018
CompletedFirst Submitted
Initial submission to the registry
April 3, 2019
CompletedFirst Posted
Study publicly available on registry
April 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2019
CompletedNovember 21, 2019
November 1, 2019
10 months
April 3, 2019
November 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Patient Reported Outcomes Measurement Information System (PROMIS) Self Efficacy Scale
Baseline to post-treatment (6 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale
Baseline to post-treatment (6 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
Baseline to post-treatment (6 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale
Baseline to post-treatment (6 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Scale
Baseline to post-treatment (6 weeks)
- +4 more secondary outcomes
Study Arms (2)
CBT-H (Individual format)
EXPERIMENTALIndividual 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.
CBT-H (Group format)
EXPERIMENTALGroup-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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Circadian and Sleep Medicine, Northwestern University
Chicago, Illinois, 60611, United States
Related Publications (1)
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.
PMID: 32804069DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 3, 2019
First Posted
April 5, 2019
Study Start
December 10, 2018
Primary Completion
September 30, 2019
Study Completion
October 7, 2019
Last Updated
November 21, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share