Telehealth Cognitive Behavioral Stress Management for Adults With Cystic Fibrosis
2020年9月8日 更新者：Christina Bathgate、National Jewish Health
The purpose of this study to to assess the feasibility, acceptability, and satisfaction of a telehealth cognitive behavioral stress management (CBSM) intervention among adults with cystic fibrosis (CF) who exhibit elevated anxiety and/or depression symptoms.
調査の概要
研究の種類
介入
入学 (実際)
31
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Colorado
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Denver、Colorado、アメリカ、80206
- National Jewish Health
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～80年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- At least 18 years old
- Fluent in English
- Diagnosed with Cystic Fibrosis
- Colorado resident
- Access to personal device (smart phone, computer, tablet) with 1) reliable internet connection, and 2) a built-in web camera and microphone or the capability to install a study-provided web camera and microphone
- Regular access to a private location with sufficient lighting that is free from distractions or intrusions to use during telehealth sessions
- Access to private email to complete surveys
- Mild anxiety and/or depression symptoms (i.e., a score of 5 or higher on the Generalized Anxiety Disorder 7 Item Scale (GAD-7) and/or the Patient Health Questionnaire 9 Item Scale (PHQ-9))
Exclusion Criteria:
- Currently receiving therapy or counseling with an outside provider for a mental health condition
- Currently in treatment for alcohol or substance abuse
- Unstable medical condition (not including cystic fibrosis)
- Neurological disease
- Pregnant women
- Active suicidal intent or plan (a score of 1 or higher on the Suicide Severity Scale)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Telehealth
Participants randomized into the telehealth arm will receive up to 7 one-hour telehealth visits with the study psychologist.
The first six sessions will focus on cognitive behavioral stress management topics and the seventh session is optional, focusing on lung transplant readiness.
Participants will fill out questionnaires every other week (baseline, week 2, week 4, week 6, week 8) and during a 3-month follow-up (week 20).
Participants will wear an actigraphy watch to track sleep and movement for one week at a time during baseline, week 8, and week 20.
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Cognitive behavioral stress management is a well-established, practical intervention that combines elements of cognitive behavioral therapy with techniques designed to improve coping skills, social support, communication, and relaxation/mindfulness.
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介入なし：Treatment-As-Usual (TAU)
Participants randomized into the TAU arm will not receive any telehealth visits during the 8-week intervention phase. Participants will fill out questionnaires every other week (baseline, week 2, week 4, week 6, week 8) and during a 3-month follow-up (week 20). Participants will wear an actigraphy watch to track sleep and movement for one week at a time during baseline, week 8, and week 20. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feasibility (patient perspective)
時間枠：Week 0 (baseline)
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Assess the feasibility of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective using participation rates (i.e., number of people interested and consented into the study).
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Week 0 (baseline)
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Feasibility (clinician perspective)
時間枠：Week 8
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Assess the feasibility of telehealth-delivered Cognitive Behavioral Stress Management from the clinician perspective using the Structured Assessment of Feasibility (SAFE; 16 items).
The first 8 items provide information about barriers to implementation and the second 8 items provide information about enablers to implementation.
It is recommended that no overall summary score be used, as this scale is designed to highlight barriers and facilitators that future programs should consider if they decide to continue or begin implementing this intervention.
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Week 8
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Acceptability (patient perspective 1 of 2)
時間枠：Week 8
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Assess the acceptability of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective using participation rates (i.e., telehealth sessions completed, dropouts).
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Week 8
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Acceptability (patient perspective 2 of 2)
時間枠：Week 8
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Assess the acceptability of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective using the Acceptability Scale (12 items; 5 = strongly agree, 1 = strongly disagree), which was adapted specifically for this study.
A mean acceptability score will be computed from these 12 items.
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Week 8
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Satisfaction (patient perspective 1 of 2)
時間枠：Week 8
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Assess the satisfaction of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective.
Satisfaction measured using the Satisfaction Scale (8 items; 5 = strongly agree, 1 = strongly disagree), which was adapted specifically for this study.
A mean satisfaction score will be computed from the 8 items.
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Week 8
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Satisfaction (patient perspective 2 of 2)
時間枠：Week 8
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Assess the satisfaction of telehealth-delivered Cognitive Behavioral Stress Management from the patient perspective using 4 open-ended questions designed specifically for this study.
A qualitative summary will be provided based on responses to the open ended questions.
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Week 8
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Anxiety symptom improvement
時間枠：Week 0, 2, 4, 6, 8, 20
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Assess changes in anxiety throughout study using the Generalized Anxiety Disorder 7-item Scale (GAD-7), which asks participants to rate how much they have been bothered by anxiety symptoms over the past 2 weeks (7 items, 0 = not at all, 1= several days, 2= more than half the days 3 = nearly every day).
A total score will be created by summing the scores of the 7 items.
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Week 0, 2, 4, 6, 8, 20
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Depression symptom improvement
時間枠：Week 0, 2, 4, 6, 8, 20
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Assess changes in depression throughout study using the Patient Health Questionnaire 9-item Scale (PHQ-9), which asks participants to rate how much they have been bothered by depression symptoms over the past 2 weeks (9 items, 0 = not at all, 1= several days, 2= more than half the days 3 = nearly every day).
A total score will be created by summing the scores of the 9 items.
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Week 0, 2, 4, 6, 8, 20
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：CJ Bathgate, PhD、National Jewish Health
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年6月4日
一次修了 (実際)
2020年6月1日
研究の完了 (実際)
2020年6月1日
試験登録日
最初に提出
2018年5月3日
QC基準を満たした最初の提出物
2018年6月6日
最初の投稿 (実際)
2018年6月18日
学習記録の更新
投稿された最後の更新 (実際)
2020年9月9日
QC基準を満たした最後の更新が送信されました
2020年9月8日
最終確認日
2020年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。