Development of a Couple-based Mindfulness Intervention for Chronic Pain
11. května 2017 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
48
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
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Michigan
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Detroit, Michigan, Spojené státy, 48202
- Wayne State University
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
21 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Depressive Symptoms from Baseline to 1-month Followup
Časové okno: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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
Časové okno: 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
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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
Časové okno: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
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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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Acceptance of Chronic Pain
Časové okno: 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
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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
Časové okno: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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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
Časové okno: 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
|
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Change in Values-Based Action
Časové okno: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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
Časové okno: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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
Časové okno: 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
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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
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Treatment Credibility
Časové okno: Baseline
|
Credibility of Treatment Scale
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Baseline
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Therapist Adherence
Časové okno: 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
Časové okno: Participants will be followed for the duration of the intervention, an expected average of 6 weeks
|
Homework Rating Scale and time spend completing homework
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Participants will be followed for the duration of the intervention, an expected average of 6 weeks
|
|
Therapy Session Satisfaction
Časové okno: 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
Časové okno: 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
|
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Adverse Events
Časové okno: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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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
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Annmarie Cano, Ph.D., Wayne State University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. prosince 2014
Primární dokončení (Aktuální)
1. května 2017
Dokončení studie (Aktuální)
1. května 2017
Termíny zápisu do studia
První předloženo
4. prosince 2014
První předloženo, které splnilo kritéria kontroly kvality
9. prosince 2014
První zveřejněno (Odhad)
12. prosince 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
15. května 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
11. května 2017
Naposledy ověřeno
1. května 2017
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 1R21AT007939-01A1 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .