Psychosocial Adjunctive Treatment for Hypersomnia (PATH)
キーワード
概要
説明
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.
日付
| 最終確認済み: | 10/31/2019 |
| 最初に提出された: | 04/02/2019 |
| 提出された推定登録数: | 04/02/2019 |
| 最初の投稿: | 04/04/2019 |
| 最終更新が送信されました: | 11/18/2019 |
| 最終更新日: | 11/20/2019 |
| 実際の研究開始日: | 12/09/2018 |
| 一次完了予定日: | 09/29/2019 |
| 研究完了予定日: | 10/06/2019 |
状態または病気
介入/治療
Behavioral: Cognitive-Behavior Therapy for Hypersomnia (CBT-H)
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: CBT-H (Individual format) Individual 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. | |
| Experimental: CBT-H (Group format) Group-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. |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | 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. |
結果
主な結果の測定
1. Patient Health Questionnaire (PHQ) [Change from Baseline PHQ at 6 weeks (Post-treatment)]
二次的な結果の測定
1. Patient Reported Outcomes Measurement Information System (PROMIS) Self Efficacy Scale [Baseline to post-treatment (6 weeks)]
2. Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale [Baseline to post-treatment (6 weeks)]
3. Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale [Baseline to post-treatment (6 weeks)]
4. Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale [Baseline to post-treatment (6 weeks)]
5. Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Scale [Baseline to post-treatment (6 weeks)]
6. Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale [Baseline to post-treatment (6 weeks)]
7. Patient Reported Outcomes Measurement Information System (PROMIS) Phyiscal Function Scale [Baseline to post-treatment (6 weeks)]
8. Epworth Sleepiness Scale (ESS) [Baseline to post-treatment (6 weeks)]
9. Functional Outcomes of Sleep Questionaire (FOSQ) [Baseline to post-treatment (6 weeks)]
