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Telehealth Therapy for Chronic Pain: Comparison of In-person vs. Video-administered ACT for Pain (TTCP)

30 de junho de 2016 atualizado por: VA Office of Research and Development

Telehealth Therapy for Chronic Pain

The purpose of the study is to test a brief, individual psychosocial in-person or telehealth intervention to reduce interference of pain with daily life, emotional distress, and pain intensity, and improve quality of life and physical activity levels in individuals with chronic pain.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

Chronic pain affects at least 15% of the veteran population and represents a high priority for the VA. In addition to primary pain conditions, chronic pain is a common secondary condition resulting from battlefield injuries, traumatic accidents, and congenital and acquired disorders. Unlike most forms of acute pain, treatment options available for patients suffering from chronic pain frequently offer only short-term or partial relief from symptoms. The focus of rehabilitative intervention thus becomes the reduction of disability and emotional distress and improvement in quality of life and activity levels.

Chronic pain rehabilitation has evolved from a primarily one dimensional, medically oriented approach to a multidisciplinary approach that incorporates a biopsychosocial formulation to pain management with physiological, cognitive, behavioral, and emotional components. This conceptualization of pain recognizes that multiple intervention modalities, including psychosocial approaches, are required when providing treatment to chronic pain patients.

A relatively new psychosocial approach to chronic pain management and rehabilitation involves acceptance of pain-related experiences. The Acceptance and Commitment Therapy (ACT) model is based on the theory that attempts to escape, avoid, or control negative experiences that cannot be changed, such as chronic pain, may paradoxically contribute to the increased experience of them. Instead of seeking to control the negative experience, ACT teaches individuals to use mindfulness strategies to enlarge the scope of experience beyond pain and to engage in behaviors that are consistent with personal values and goals when total elimination of pain or other negative experiences is not possible. Empirical support for acceptance-based approaches to chronic pain management is growing. Data from one of the first comparisons of ACT to a well-established psychosocial intervention, Cognitive-Behavioral Therapy (CBT), performed at the VA San Diego Healthcare System (VASDHS) by the PI, suggests that ACT may be superior to CBT as an adjunctive treatment for chronic pain.

The proposed study assembles a multidisciplinary team with extensive experience in chronic pain interventions research to evaluate the benefits of a brief, individual psychosocial in-person or telehealth intervention which could be easily integrated into multidisciplinary pain rehabilitation programs throughout the VA system to reduce disability in veterans with chronic pain secondary to other conditions. Specifically, we propose to examine the effects of a promising new chronic pain intervention based on ACT principles on the primary outcome of pain interference and secondary outcomes of emotional distress, quality of life, physical activity, pain intensity, and treatment satisfaction among 196 veterans with chronic benign pain as a secondary condition. The participants are randomized to between-subjects design where in-person ACT intervention will be compared with telehealth ACT intervention. Outcomes include an objective measure of physical activity, actigraphy, as well as self-reported measures and will be evaluated at baseline, 4 weeks, 8 weeks (end of treatment), 3-month follow-up and at a 6-month follow-up period to investigate maintenance of gains. Telehealth sessions are conducted using secure video-conferencing equipment at the most convenient clinic for the participant. Thus, the proposed project has the potential to enhance the current VA standard of care as well as to add to the scientific literature on psychological models and rehabilitation of chronic pain.

Tipo de estudo

Intervencional

Inscrição (Real)

126

Estágio

  • Fase 2

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

    • California
      • San Diego, California, Estados Unidos, 92161
        • VA San Diego Healthcare System, San Diego

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Chronic non-terminal pain condition;
  • Pain severity and interference rated > 4/10; and
  • Pain most days (> 3/week) for at least 6 months.

Exclusion Criteria:

  • Current participation in group psychotherapy for pain or any type of individual psychotherapy;
  • Previous treatment with ACT;
  • Active suicide ideation or history of suicide attempt within 5 years;
  • Serious or unstable medical or psychiatric illness or psychosocial instability that could compromise study participation; and
  • The following DSM-IV diagnoses or active problems within the past 6 months noted in the patient's Computerized Patient Record System (CPRS) medical record or diagnosed during a structured psychiatric interview:

    • schizophrenia;
    • other psychotic disorder;
    • bipolar disorder;
    • organic mental disorder;
    • borderline or antisocial personality disorder; or
    • alcohol or substance abuse or dependence.

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
Comparador Ativo: In-person ACT
8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
Experimental: Telehealth ACT
8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.
8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Brief Pain Inventory-interference Subscale
Prazo: 8 weeks
The primary outcome measure for the proposed study is the Brief Pain Inventory Short Form Interference subscale (BPI; Cleeland & Ryan, 1994). This 7-item scale, recommended by the IMMPACT group as a measure of functioning (Dworkin et al., 2005), measures the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Scores range from 0 (least interference due to pain) to 10 (most interference due to pain).
8 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Brief Pain Inventory-severity Subscale
Prazo: 8 weeks
The Brief Pain Inventory Short Form (BPI; Cleeland & Ryan, 1994) includes a 4-item pain severity subscale measuring the level of pain over the past week on average, at its worst, at its least, and currently. This measure is recommended by the IMMPACT group as a pain assessment tool (Dworkin et al., 2005). Scores range from 0 (least pain severity) to 10 (most pain severity).
8 weeks
West Haven-Yale Multidimensional Pain Inventory - Activity Subscales
Prazo: 8 weeks
The West Haven-Yale Multidimensional Pain Inventory (MPI; Kerns et al., 1985) contains 52 items forming 12 subscales. For this study, we used four subscales assessing various types of activities. Household Chores (5 items); Outdoor Work (5 items); Activities Away From Home (4 items); and Social Activities (4 items). The MPI has been used extensively in outcome research with heterogeneous samples of chronic pain patients, including veterans, and has demonstrated sensitivity to treatment change (Altmaier et al., 1992; Mikail et al., 1993). Individual items are rated on a 7-point Likert scale from 0-6, and subscales are scored by averaging items together. Therefore, the score for Part III, General Activity, is composed of an average of the 18 items in the Household Chores (5 items); Outdoor Work (5 items); Activities Away From Home (4 items); and Social Activities (4 items) subscales. The final score ranges from 0 (lowest level of activity) to 6 (highest level of activity).
8 weeks
SF-12 MCS
Prazo: 8 weeks
6-item self-report measure of mental health-related quality of life. Subscale of the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12; Ware et al., 1994). This measure is widely used with populations with chronic disease. The Physical and Mental Component Summary scores correlate .91 and .92 with the corresponding scores derived from the SF-36, and 2-week test-retest reliability correlations were .89 and .76 (Ware et al., 1994). The Short Form Health Survey is recommended by the IMMPACT group (Dworkin et al., 2005). Scores range from 0 (lowest functioning) to 100 (highest functioning).
8 weeks
SF-12 PCS
Prazo: 8 weeks
Physical health-related quality of life will be measured using the Physical Component Summary score of the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12; Ware et al., 1994). This measure is widely used with populations with chronic disease. The Physical and Mental Component Summary scores correlate .91 and .92 with the corresponding scores derived from the SF-36, and 2-week test-retest reliability correlations were .89 and .76 (Ware et al., 1994). The Short Form Health Survey is recommended by the IMMPACT group (Dworkin et al., 2005). Scores range from 0 (lowest functioning) to 100 (highest functioning).
8 weeks
Patient Health Questionnaire-9
Prazo: 8 weeks
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The tool rates the frequency of the symptoms which factors into the scoring severity index. Scores range from 0 (lowest level of depressive symptoms) to 27 (highest level of depressive symptoms).
8 weeks
Pain Anxiety Symptom Scale - 20
Prazo: 8 weeks
Anxiety will be assessed with the 20-item Pain Anxiety Symptoms Scale-Short Form (PASS-20; McCracken & Dhingra, 2002). Pain anxiety captures fears patients associate with their symptoms, which are typically associated with the belief that their pain signals harm. High levels of pain anxiety compromise patient's activity levels, participation in rehabilitation, and performance on functional tests. The instrument is a valid and reliable measure of anxiety symptoms in pain populations (McCracken et al., 1996; Roelofs et al., 2004). The PASS-20 items are scored on a 6-point Likert scale and assess cognitive, escape/avoidance, fear, and physiological anxiety dimensions. Internal consistency is high and correlation between the short and long form is excellent (alpha=.81; r=.97). This measure has been recommended by the VA and demonstrated sensitivity to treatment in the pilot sample (National VA Pain Outcomes Working Group, 2003). Scores range from 0 (least anxiety) to 100 (most anxiety).
8 weeks
PTSD Checklist
Prazo: 8 weeks
The 17-item PTSD Checklist (Weathers et al., 1994) will be used to assess PTSD symptoms. In combat veterans, this questionnaire has high test-retest reliability (0.96) and validity as indicated by a kappa of 0.64 for diagnosis of PTSD using the SCID (Weathers et al., 1993). Scores range from 17 (low PTSD) to 85 (high PTSD).
8 weeks
Pittsburgh Sleep Quality Index
Prazo: 8 weeks
The 19-item Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989) is the most commonly used measure of self-rated sleep quality, with good reliability (alpha = .83, test-retest = .85) and validity (kappa = 0.75) for distinguishing good and poor sleepers. A survey recently conducted by the IMMPACT group indicated that sleep is one of the domains most important to patients with chronic pain (Turk et al., 2008), and the PSQI is the scale most frequently used to evaluate sleep quality in studies of chronic pain patients (Cole et al., 2007). Scores range from 0 (good sleep) to 42 (poor sleep).
8 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Julie L Wetherell, PhD, VA San Diego Healthcare System, San Diego

Publicações e links úteis

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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 fevereiro de 2010

Conclusão Primária (Real)

1 de junho de 2013

Conclusão do estudo (Real)

1 de setembro de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

21 de janeiro de 2010

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de janeiro de 2010

Primeira postagem (Estimativa)

25 de janeiro de 2010

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

12 de agosto de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de junho de 2016

Última verificação

1 de junho de 2015

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • F6891-R
  • 091019 (Número de outro subsídio/financiamento: GRANT00557035)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

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