Development of a Couple-based Mindfulness Intervention for Chronic Pain

Chronic Pain Clinical Trial

Official title:

Preliminary Test of an Integrative Intervention to Alleviate Chronic Pain and Improve Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316288
• Other study ID #: 1R21AT007939-01A1
• Status: Completed
• Phase: N/A
• First received: December 4, 2014
• Last updated: May 11, 2017
• Start date: December 2014
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Credibility	Credibility of Treatment Scale	Baseline
Other	Therapist Adherence	audio recordings of sessions	Participants will be followed for the duration of the intervention, an expected average of 6 weeks
Other	Therapy Homework Compliance	Homework Rating Scale and time spend completing homework	Participants will be followed for the duration of the intervention, an expected average of 6 weeks
Other	Therapy Session Satisfaction	Participants' satisfaction with session	Participants will be followed for the duration of the intervention, an expected average of 6 weeks
Other	Intent to Complete Therapy Homework	Participants' intention to complete homework	Participants will be followed for the duration of the intervention, an expected average of 6 weeks
Other	Adverse Events	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
Primary	Change in Depressive Symptoms from Baseline to 1-month Followup	Beck Depression Inventory-II	Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Primary	Change in Pain Intensity	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
Primary	Change in Pain Quality	McGill Pain Questionnaire	Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Primary	Change in Quality of Life	Satisfaction with Life Scale	Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Primary	Change in Relationship Satisfaction	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
Primary	Change in Sleep Quality	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
Primary	Change in Perceived Improvement	Patient Global Impression of Change	Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Secondary	Change in Acceptance of Chronic Pain	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
Secondary	Change in Anxiety and Catastrophizing about Pain	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
Secondary	Change in Mindfulness	Five Facet Mindfulness Scale	Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Secondary	Change in Values-Based Action	Chronic Pain Values Inventory	Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Secondary	Change in Dispositional Empathy	Interpersonal Reactivity Index	Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Secondary	Change in Emotional Expression	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
Secondary	Change in Emotional Validation and Invalidation	Coded from Couple Discussion Task	Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Secondary	Change in Partner-perceived Empathy	Perceived Partner Responsiveness Scale	Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks