Development of a Couple-based Mindfulness Intervention for Chronic Pain
11 de maio de 2017 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
48
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Wayne State University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
21 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Depressive Symptoms from Baseline to 1-month Followup
Prazo: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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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
Prazo: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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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
Prazo: 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
Prazo: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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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
Prazo: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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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
Prazo: 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
Prazo: 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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Acceptance of Chronic Pain
Prazo: 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
Prazo: 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
Prazo: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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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
Prazo: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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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
Prazo: 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
Prazo: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Treatment Credibility
Prazo: Baseline
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Credibility of Treatment Scale
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Baseline
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Therapist Adherence
Prazo: Participants will be followed for the duration of the intervention, an expected average of 6 weeks
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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
Prazo: Participants will be followed for the duration of the intervention, an expected average of 6 weeks
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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
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Therapy Session Satisfaction
Prazo: Participants will be followed for the duration of the intervention, an expected average of 6 weeks
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Participants' satisfaction with session
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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
Prazo: Participants will be followed for the duration of the intervention, an expected average of 6 weeks
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Participants' intention to complete homework
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Participants will be followed for the duration of the intervention, an expected average of 6 weeks
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Adverse Events
Prazo: 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
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Annmarie Cano, Ph.D., Wayne State University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de dezembro de 2014
Conclusão Primária (Real)
1 de maio de 2017
Conclusão do estudo (Real)
1 de maio de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
4 de dezembro de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de dezembro de 2014
Primeira postagem (Estimativa)
12 de dezembro de 2014
Atualizações de registro de estudo
Última Atualização Postada (Real)
15 de maio de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de maio de 2017
Última verificação
1 de maio de 2017
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1R21AT007939-01A1 (Concessão/Contrato do NIH dos EUA)
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