Development of a Couple-based Mindfulness Intervention for Chronic Pain
2017年5月11日 更新者:Annmarie Cano、Wayne State University
Preliminary Test of an Integrative Intervention to Alleviate Chronic Pain and Improve Quality of Life
Chronic pain is a costly public health problem that is associated with poor quality of life.
Previous research has demonstrated extensive evidence showing that pain coping is not manifested by patients in isolation but within the context of significant relationships such as marriage.
For instance, a partner may avoid or reject their partners' negative emotions about pain, provide unempathic responses to their partners' pain, or change their thoughts about pain.
The patient's pain experience and the couples' relationship also have a cyclical relationship, in which both can affect each other and the overall quality of life for both partners.
Currently, current clinical practice does not target both partners to alleviate pain.
This is highly problematic given that a number of chronic pain patients-those with interpersonal distress-often do not complete, and thus, do not benefit fully from existing treatments.
Even if treatment is completed, individuals may not maintain improvements if they return to distressed social environments that undermine individual coping efforts.
Thus, it is clear that new interventions derived from integrative models of individual and dyadic coping are needed to alleviate pain and suffering in patients who are at risk for poor treatment outcomes.
This research study aims to develop a novel psychological intervention aimed at couples in which one partner has chronic pain.
Our central hypothesis is that a theoretically integrative intervention that improves both partners' psychological flexibility (i.e., acceptance, mindfulness, values-based action) and relational flexibility (i.e., emotional disclosure, empathic responding) skills will be feasible and valid and that it will alleviate pain and improve quality of life.
This is a departure from current practice, which focuses solely on the patient's individual functioning, does not address the spouse's psychological inflexibility, and does not address relationship issues.
調査の概要
研究の種類
介入
入学 (実際)
48
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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Michigan
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Detroit、Michigan、アメリカ、48202
- Wayne State University
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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
21年歳以上 (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 one spouse with some pain interference.
- Relationship dissatisfaction.
- Both partners at least 21 years old.
- Couples must also be married or cohabitating for at least 2 years regardless of sexual orientation to participate in the study.
Exclusion Criteria:
- Current suicidal or homicidal ideation or intent
- Current psychotic symptoms
- Cognitive impairment
- Malignancies (e.g., cancer) in either partner
- Current domestic violence
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:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Therapy
Mindfulness and Acceptance Therapy
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Couples will learn psychological flexibility skills including mindfulness, acceptance, and values-based action as well as relational flexibility skills including empathic listening and responding during weekly 1.5-hour long sessions over the course of this 6-week intervention.
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アクティブコンパレータ:Education
Health Education
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Couples will learn about chronic pain including causes, consequences, and how to talk with their health care professionals about their pain during weekly 1.5-hour long sessions over the course of this 6-week program.
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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 |
---|---|---|
Change in Depressive Symptoms from Baseline to 1-month Followup
時間枠:Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Beck Depression Inventory-II
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Change in Pain Intensity
時間枠:Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Visual Rating Scale, Multidimensional Pain Inventory, Brief Pain Inventory
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Change in Pain Quality
時間枠:Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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McGill Pain Questionnaire
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Change in Quality of Life
時間枠:Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Satisfaction with Life Scale
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Change in Relationship Satisfaction
時間枠:Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Dyadic Adjustment Scale; Dyadic Adjustment Scale-7
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Change in Sleep Quality
時間枠:Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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PROMIS Sleep Disturbance and Sleep-related Impairment Scales
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Change in Perceived Improvement
時間枠:Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Patient Global Impression of Change
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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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 |
---|---|---|
Change in Acceptance of Chronic Pain
時間枠:Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Chronic Pain Acceptance Questionnaire (baseline, post-treatment, followup); Chronic Pain Acceptance Chronic Pain Acceptance Questionnaire
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Change in Anxiety and Catastrophizing about Pain
時間枠:Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Pain Anxiety Symptoms Scale, Pain Catastrophizing Scale (baseline, post-treatment, followup); Pain Catastrophizing Scale-Shortened Version (weekly)
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Change in Mindfulness
時間枠:Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Five Facet Mindfulness Scale
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Change in Values-Based Action
時間枠:Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Chronic Pain Values Inventory
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Change in Dispositional Empathy
時間枠:Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Interpersonal Reactivity Index
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Change in Emotional Expression
時間枠:Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Ambivalence Over Emotional Expression Questionnaire, Holding Back Scale
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Change in Emotional Validation and Invalidation
時間枠:Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Coded from Couple Discussion Task
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Change in Partner-perceived Empathy
時間枠:Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Perceived Partner Responsiveness Scale
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Treatment Credibility
時間枠:Baseline
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Credibility of Treatment Scale
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Baseline
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Therapist Adherence
時間枠:Participants will be followed for the duration of the intervention, an expected average of 6 weeks
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audio recordings of sessions
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Participants will be followed for the duration of the intervention, an expected average of 6 weeks
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Therapy Homework Compliance
時間枠:Participants will be followed for the duration of the intervention, an expected average of 6 weeks
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Homework Rating Scale and time spend completing homework
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Participants will be followed for the duration of the intervention, an expected average of 6 weeks
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Therapy Session Satisfaction
時間枠:Participants will be followed for the duration of the intervention, an expected average of 6 weeks
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Participants' satisfaction with session
|
Participants will be followed for the duration of the intervention, an expected average of 6 weeks
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Intent to Complete Therapy Homework
時間枠:Participants will be followed for the duration of the intervention, an expected average of 6 weeks
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Participants' intention to complete homework
|
Participants will be followed for the duration of the intervention, an expected average of 6 weeks
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Adverse Events
時間枠:Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Adverse event data will be collected and reported
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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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:Annmarie Cano, Ph.D.、Wayne State University
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
2014年12月1日
一次修了 (実際)
2017年5月1日
研究の完了 (実際)
2017年5月1日
試験登録日
最初に提出
2014年12月4日
QC基準を満たした最初の提出物
2014年12月9日
最初の投稿 (見積もり)
2014年12月12日
学習記録の更新
投稿された最後の更新 (実際)
2017年5月15日
QC基準を満たした最後の更新が送信されました
2017年5月11日
最終確認日
2017年5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。
慢性の痛みの臨床試験
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Dexa Medica Group完了
Mindfulness and Acceptance Therapyの臨床試験
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Training and Implementation Associates募集従来の対面トレーニング | 家族療法のトレーニングと実装プラットフォーム (FTTIP)アメリカ