Development of a Couple-based Mindfulness Intervention for Chronic Pain
11 maja 2017 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
48
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Michigan
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Detroit, Michigan, Stany Zjednoczone, 48202
- Wayne State University
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-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
21 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
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Aktywny komparator: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Depressive Symptoms from Baseline to 1-month Followup
Ramy czasowe: 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
Ramy czasowe: 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
|
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Change in Pain Quality
Ramy czasowe: 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
|
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Change in Quality of Life
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Acceptance of Chronic Pain
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
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Change in Partner-perceived Empathy
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Treatment Credibility
Ramy czasowe: Baseline
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Credibility of Treatment Scale
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Baseline
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Therapist Adherence
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Annmarie Cano, Ph.D., Wayne State University
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 grudnia 2014
Zakończenie podstawowe (Rzeczywisty)
1 maja 2017
Ukończenie studiów (Rzeczywisty)
1 maja 2017
Daty rejestracji na studia
Pierwszy przesłany
4 grudnia 2014
Pierwszy przesłany, który spełnia kryteria kontroli jakości
9 grudnia 2014
Pierwszy wysłany (Oszacować)
12 grudnia 2014
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
15 maja 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
11 maja 2017
Ostatnia weryfikacja
1 maja 2017
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 1R21AT007939-01A1 (Grant/umowa NIH USA)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .