Development of a Couple-based Mindfulness Intervention for Chronic Pain
11 мая 2017 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
48
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Michigan
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Detroit, Michigan, Соединенные Штаты, 48202
- Wayne State University
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
21 год и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Активный компаратор: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Depressive Symptoms from Baseline to 1-month Followup
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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
Временное ограничение: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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
Временное ограничение: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Acceptance of Chronic Pain
Временное ограничение: 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
Временное ограничение: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Treatment Credibility
Временное ограничение: Baseline
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Credibility of Treatment Scale
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Baseline
|
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Therapist Adherence
Временное ограничение: Participants will be followed for the duration of the intervention, an expected average of 6 weeks
|
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
Временное ограничение: Participants will be followed for the duration of the intervention, an expected average of 6 weeks
|
Homework Rating Scale and time spend completing homework
|
Participants will be followed for the duration of the intervention, an expected average of 6 weeks
|
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Therapy Session Satisfaction
Временное ограничение: Participants will be followed for the duration of the intervention, an expected average of 6 weeks
|
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
Временное ограничение: 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
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Participants will be followed for the duration of the intervention, an expected average of 6 weeks
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Adverse Events
Временное ограничение: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Annmarie Cano, Ph.D., Wayne State University
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 декабря 2014 г.
Первичное завершение (Действительный)
1 мая 2017 г.
Завершение исследования (Действительный)
1 мая 2017 г.
Даты регистрации исследования
Первый отправленный
4 декабря 2014 г.
Впервые представлено, что соответствует критериям контроля качества
9 декабря 2014 г.
Первый опубликованный (Оценивать)
12 декабря 2014 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
15 мая 2017 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
11 мая 2017 г.
Последняя проверка
1 мая 2017 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 1R21AT007939-01A1 (Грант/контракт NIH США)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .