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Development of a Couple-based Mindfulness Intervention for Chronic Pain

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness and Acceptance Therapy
Health Education
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wayne State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Therapy

Education

Arm Description

Mindfulness and Acceptance Therapy

Health Education

Outcomes

Primary Outcome Measures

Change in Depressive Symptoms from Baseline to 1-month Followup
Beck Depression Inventory-II
Change in Pain Intensity
Visual Rating Scale, Multidimensional Pain Inventory, Brief Pain Inventory
Change in Pain Quality
McGill Pain Questionnaire
Change in Quality of Life
Satisfaction with Life Scale
Change in Relationship Satisfaction
Dyadic Adjustment Scale; Dyadic Adjustment Scale-7
Change in Sleep Quality
PROMIS Sleep Disturbance and Sleep-related Impairment Scales
Change in Perceived Improvement
Patient Global Impression of Change

Secondary Outcome Measures

Change in Acceptance of Chronic Pain
Chronic Pain Acceptance Questionnaire (baseline, post-treatment, followup); Chronic Pain Acceptance Chronic Pain Acceptance Questionnaire
Change in Anxiety and Catastrophizing about Pain
Pain Anxiety Symptoms Scale, Pain Catastrophizing Scale (baseline, post-treatment, followup); Pain Catastrophizing Scale-Shortened Version (weekly)
Change in Mindfulness
Five Facet Mindfulness Scale
Change in Values-Based Action
Chronic Pain Values Inventory
Change in Dispositional Empathy
Interpersonal Reactivity Index
Change in Emotional Expression
Ambivalence Over Emotional Expression Questionnaire, Holding Back Scale
Change in Emotional Validation and Invalidation
Coded from Couple Discussion Task
Change in Partner-perceived Empathy
Perceived Partner Responsiveness Scale

Full Information

First Posted
December 4, 2014
Last Updated
May 11, 2017
Sponsor
Wayne State University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02316288
Brief Title
Development of a Couple-based Mindfulness Intervention for Chronic Pain
Official Title
Preliminary Test of an Integrative Intervention to Alleviate Chronic Pain and Improve Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapy
Arm Type
Experimental
Arm Description
Mindfulness and Acceptance Therapy
Arm Title
Education
Arm Type
Active Comparator
Arm Description
Health Education
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness and Acceptance Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Depressive Symptoms from Baseline to 1-month Followup
Description
Beck Depression Inventory-II
Time Frame
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Title
Change in Pain Intensity
Description
Visual Rating Scale, Multidimensional Pain Inventory, Brief Pain Inventory
Time Frame
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Title
Change in Pain Quality
Description
McGill Pain Questionnaire
Time Frame
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Title
Change in Quality of Life
Description
Satisfaction with Life Scale
Time Frame
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Title
Change in Relationship Satisfaction
Description
Dyadic Adjustment Scale; Dyadic Adjustment Scale-7
Time Frame
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Title
Change in Sleep Quality
Description
PROMIS Sleep Disturbance and Sleep-related Impairment Scales
Time Frame
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Title
Change in Perceived Improvement
Description
Patient Global Impression of Change
Time Frame
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Secondary Outcome Measure Information:
Title
Change in Acceptance of Chronic Pain
Description
Chronic Pain Acceptance Questionnaire (baseline, post-treatment, followup); Chronic Pain Acceptance Chronic Pain Acceptance Questionnaire
Time Frame
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Title
Change in Anxiety and Catastrophizing about Pain
Description
Pain Anxiety Symptoms Scale, Pain Catastrophizing Scale (baseline, post-treatment, followup); Pain Catastrophizing Scale-Shortened Version (weekly)
Time Frame
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Title
Change in Mindfulness
Description
Five Facet Mindfulness Scale
Time Frame
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Title
Change in Values-Based Action
Description
Chronic Pain Values Inventory
Time Frame
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Title
Change in Dispositional Empathy
Description
Interpersonal Reactivity Index
Time Frame
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Title
Change in Emotional Expression
Description
Ambivalence Over Emotional Expression Questionnaire, Holding Back Scale
Time Frame
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Title
Change in Emotional Validation and Invalidation
Description
Coded from Couple Discussion Task
Time Frame
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Title
Change in Partner-perceived Empathy
Description
Perceived Partner Responsiveness Scale
Time Frame
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Other Pre-specified Outcome Measures:
Title
Treatment Credibility
Description
Credibility of Treatment Scale
Time Frame
Baseline
Title
Therapist Adherence
Description
audio recordings of sessions
Time Frame
Participants will be followed for the duration of the intervention, an expected average of 6 weeks
Title
Therapy Homework Compliance
Description
Homework Rating Scale and time spend completing homework
Time Frame
Participants will be followed for the duration of the intervention, an expected average of 6 weeks
Title
Therapy Session Satisfaction
Description
Participants' satisfaction with session
Time Frame
Participants will be followed for the duration of the intervention, an expected average of 6 weeks
Title
Intent to Complete Therapy Homework
Description
Participants' intention to complete homework
Time Frame
Participants will be followed for the duration of the intervention, an expected average of 6 weeks
Title
Adverse Events
Description
Adverse event data will be collected and reported
Time Frame
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annmarie Cano, Ph.D.
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Development of a Couple-based Mindfulness Intervention for Chronic Pain

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