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Development of a Couple-based Mindfulness Intervention for Chronic Pain

2017년 5월 11일 업데이트: 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.

연구 개요

연구 유형

중재적

등록 (실제)

48

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Michigan
      • Detroit, Michigan, 미국, 48202
        • Wayne State University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

21년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Therapy
Mindfulness and Acceptance Therapy
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.
활성 비교기: Education
Health Education
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Depressive Symptoms from Baseline to 1-month Followup
기간: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Beck Depression Inventory-II
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Change in Pain Intensity
기간: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Visual Rating Scale, Multidimensional Pain Inventory, Brief Pain Inventory
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Change in Pain Quality
기간: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
McGill Pain Questionnaire
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Change in Quality of Life
기간: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Satisfaction with Life Scale
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Change in Relationship Satisfaction
기간: 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
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Change in Sleep Quality
기간: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
PROMIS Sleep Disturbance and Sleep-related Impairment Scales
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Change in Perceived Improvement
기간: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Patient Global Impression of Change
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Acceptance of Chronic Pain
기간: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Chronic Pain Acceptance Questionnaire (baseline, post-treatment, followup); Chronic Pain Acceptance Chronic Pain Acceptance Questionnaire
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Change in Anxiety and Catastrophizing about Pain
기간: 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)
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Change in Mindfulness
기간: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Five Facet Mindfulness Scale
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Change in Values-Based Action
기간: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Chronic Pain Values Inventory
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Change in Dispositional Empathy
기간: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Interpersonal Reactivity Index
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Change in Emotional Expression
기간: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Ambivalence Over Emotional Expression Questionnaire, Holding Back Scale
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Change in Emotional Validation and Invalidation
기간: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Coded from Couple Discussion Task
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Change in Partner-perceived Empathy
기간: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Perceived Partner Responsiveness Scale
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

기타 결과 측정

결과 측정
측정값 설명
기간
Treatment Credibility
기간: Baseline
Credibility of Treatment Scale
Baseline
Therapist Adherence
기간: Participants will be followed for the duration of the intervention, an expected average of 6 weeks
audio recordings of sessions
Participants will be followed for the duration of the intervention, an expected average of 6 weeks
Therapy Homework Compliance
기간: 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
Therapy Session Satisfaction
기간: 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
Intent to Complete Therapy Homework
기간: Participants will be followed for the duration of the intervention, an expected average of 6 weeks
Participants' intention to complete homework
Participants will be followed for the duration of the intervention, an expected average of 6 weeks
Adverse Events
기간: 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
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Annmarie Cano, Ph.D., Wayne State University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2014년 12월 1일

기본 완료 (실제)

2017년 5월 1일

연구 완료 (실제)

2017년 5월 1일

연구 등록 날짜

최초 제출

2014년 12월 4일

QC 기준을 충족하는 최초 제출

2014년 12월 9일

처음 게시됨 (추정)

2014년 12월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 5월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 5월 11일

마지막으로 확인됨

2017년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 1R21AT007939-01A1 (미국 NIH 보조금/계약)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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