Development of a Couple-based Mindfulness Intervention for Chronic Pain
11. mai 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
48
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Michigan
-
Detroit, Michigan, Forente stater, 48202
- Wayne State University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
|
|
Aktiv komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Depressive Symptoms from Baseline to 1-month Followup
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
|
Change in Sleep Quality
Tidsramme: 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
|
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Change in Perceived Improvement
Tidsramme: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Acceptance of Chronic Pain
Tidsramme: 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
Tidsramme: 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
Tidsramme: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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
|
|
Change in Values-Based Action
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Treatment Credibility
Tidsramme: Baseline
|
Credibility of Treatment Scale
|
Baseline
|
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Therapist Adherence
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Annmarie Cano, Ph.D., Wayne State University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2014
Primær fullføring (Faktiske)
1. mai 2017
Studiet fullført (Faktiske)
1. mai 2017
Datoer for studieregistrering
Først innsendt
4. desember 2014
Først innsendt som oppfylte QC-kriteriene
9. desember 2014
Først lagt ut (Anslag)
12. desember 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. mai 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. mai 2017
Sist bekreftet
1. mai 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1R21AT007939-01A1 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .