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Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Psychiatric Distress (TIPPS)

25 de maio de 2020 atualizado por: Uppsala University

Tailored Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Comorbid Psychiatric Distress

This study is a randomized controlled trial studying the efficacy of an iCBT treatment for patients with chronic pain and comorbid psychiatric distress. Half the participants will receive treatment at first, while the other half serve as a control group. After the first group has received treatment, the same program will be offered to participants in the control group. Treatment will be tailored on the level of individual participants, enabling individuals suffering a wide range of problems to be recruited. The treatment will consist of a 10-week guided self-help program, followed by a booster program and follow-up one year later. During the curse of the treatment the participants will be guided via text communication by a licensed psychologist or a candidate psychologist on their last year of studies.

The primary hypothesis is that an individually tailored CBT-treatment administered through the internet can be beneficial for patients suffering from chronic pain and comorbid psychiatric distress. The investigators expect that patients in the treatment group will show reduced levels of disability, depression and anxiety, while improving on scales measuring coping and quality of life.

Visão geral do estudo

Descrição detalhada

Patients suffering from chronic pain often experience comorbid psychiatric distress. Cognitive behavioral therapy (CBT) has been shown to be effective in treating both these problems. However delivering relevant treatment can be difficult due to logistics, cost and lack of personnel with required competence. Delivering CBT though the internet (iCBT) is a novel approach, sidestepping logistical issues while lowering costs. This however, is an area were research is lacking, and though there are several studies showing iCBT to be efficacious in treating both pain and psychiatric conditions, research on a combined approach is scarce.

This study will primarily investigate whether an individually tailored CBT-treatment administered through the internet can be beneficial for patients suffering from chronic pain and comorbid psychiatric conditions. The project will also clarify whether a following booster-program, also administered tough the internet, is helpful in maintaining and increasing effects of the initial treatment. Lastly, analysis of possible mediating variables will be able to give insight into the internal workings of the treatment itself, further elucidating efficacy of specific interventions, data which will be useful in future developments of treatment design.

The treatment will be based on a previously developed program, devised to target depression and anxiety in patients with chronic pain. The treatment will consist of a 10-week period where participants would get access to a series of treatment modules, each addressing a separate problem area using CBT techniques. The treatment includes modules addressing depression, anxiety, panic, worry, insomnia, stress, trauma, communication skills, and relaxation. The booster program will be based on the initial treatment, but will shorter, focusing on repetition, strategies for maintenance, and coping with setbacks. The platform used is an existing platform employed by Smärtcentrum at Uppsala university hospital for delivering internet based treatments.

The study will be conducted using a randomized controlled trial with a between-group design. Participants will be randomized to two groups, were one group will gain access to iCBT treatment while the second group will be a wait-list control, and will gain access to the program once treatment of the active group is finished. Participants will assessed by a licensed psychologist, and treatment modules assigned based on their individual needs. In addition to online CBT modules, consisting of information, exercises and homework assignments, all participants will have regular contact by secure email-channel with a licensed psychologist or last-year psychology student under supervision. This contact will guide treatment, providing support, feedback on homework, and if necessary clarify treatment content and help with IT-related problems interfering with treatment adherence. After a year, participants will be invited to take part in a follow-up module, consisting of limited treatment recapitulation and evaluation.

Tipo de estudo

Intervencional

Inscrição (Real)

187

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

    • Uppland
      • Uppsala, Uppland, Suécia, 75236
        • Department of Psychology, Uppsala University

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

16 anos a 70 anos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Experienced pain for at least the three previous months
  • Medically evaluated regarding the pain condition
  • Experiences at least one type of psychological distress such as: depression, anxiety, insomnia or stress
  • Access to, and ability to use, a personal computer with internet access
  • Mastery of the swedish language

Exclusion Criteria:

  • Currently undergoing or planning to undergo CBT-treatment during the course of the study
  • Currently undergoing or planning to undergo major changes in pharmacotherapy during the course of the study, or have made such changes in the last 2 months
  • Have planned surgical intervention during the course of the study
  • Currently experiencing symptoms of severe depression (scores >16 on suicidality on M.I.N.I.)
  • Currently experiencing significant symptoms of psychosis (fulfills M.I.N.I criteria for psychotic syndrome, current)
  • Currently experiencing significant symptoms of alcohol or substance abuse (fulfills M.I.N.I criteria for alcohol- or substance use disorder)

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: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Internet-delivered therapy
10 week, guided and individually tailored internet-delivered cognitive behavioral therapy.
Sem intervenção: Wait list control group
Wait list control group, receives treatment at later point.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change from baseline in depressive symptoms
Prazo: at 10 weeks
Self reported change in depressive symptoms, Montgomery-Åsberg Depression Rating Scale (MADRS-S) Swedish version, 9 items
at 10 weeks
Change from baseline in depressive symptoms
Prazo: at one-year
Self reported change in depressive symptoms, Montgomery-Åsberg Depression Rating Scale (MADRS-S) Swedish version, 9 items
at one-year
Change from baseline in psychosocial consequences of pain
Prazo: at 10 weeks
Self reported psychosocial consequences of pain, West Haven-Yale Multidimensional Pain Inventory (WHY/MPI-S part 1), Swedish version, 22 items
at 10 weeks
Change from baseline in psychosocial consequences of pain
Prazo: at one-year
Self reported psychosocial consequences of pain, West Haven-Yale Multidimensional Pain Inventory (WHY/MPI-S part 1), Swedish version, 22 items
at one-year

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change from baseline in anxiety sensitivity
Prazo: at 10 weeks
Self reported anxiety sensitivity, Anxiety Sensitivity Index (ASI), Swedish version, 16 items
at 10 weeks
Change from baseline in anxiety sensitivity
Prazo: at one-year
Self reported anxiety sensitivity, Anxiety Sensitivity Index (ASI), Swedish version, 16 items
at one-year
Change from baseline in symptoms of depression and anxiety
Prazo: at 10 weeks
Self reported symptoms of depression and anxiety, Hospital Anxiety and Depression Scale (HADS), Swedish version, 14 items
at 10 weeks
Change from baseline in symptoms of depression and anxiety
Prazo: at one-year
Self reported symptoms of depression and anxiety, Hospital Anxiety and Depression Scale (HADS), Swedish version, 14 items
at one-year
Change from baseline in pain disability
Prazo: at 10 weeks
Self reported pain disability, Pain Disability Index (PDI), Swedish version, 7 items
at 10 weeks
Change from baseline in pain disability
Prazo: at one-year
Self reported pain disability, Pain Disability Index (PDI), Swedish version, 7 items
at one-year
Change from baseline in quality of life
Prazo: at 10 weeks
Self reported quality of life, Quality of Life Inventory (QOLI), Swedish version, 7 items
at 10 weeks
Change from baseline in quality of life
Prazo: at one-year
Self reported quality of life, Quality of Life Inventory (QOLI), Swedish version, 7 items
at one-year
Fear of pain due to movement
Prazo: Baseline only
Self reported fear of movement, Tampa Scale of Kinesiophobia (TSK), Swedish version, 17 items
Baseline only
Change from baseline in insomnia symptoms
Prazo: at 10 weeks
Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version
at 10 weeks
Change from baseline in insomnia symptoms
Prazo: at one-year
Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version
at one-year
Change from baseline in PTSD symptoms
Prazo: at 10 weeks
Self reported PTSD symptoms, Post-Traumatic Stress Disorder checklist 5 (PCL-5), Swedish version
at 10 weeks
Change from baseline in PTSD symptoms
Prazo: at one-year
Self reported PTSD symptoms, Post-Traumatic Stress Disorder checklist 5 (PCL-5), Swedish version
at one-year
Change from baseline in stress
Prazo: at 10 weeks
Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version
at 10 weeks
Change from baseline in stress
Prazo: at one-year
Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version
at one-year
Change from baseline in GAD-symptoms
Prazo: at 10 weeks
Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version
at 10 weeks
Change from baseline in GAD-symptoms
Prazo: at one-year
Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version
at one-year
Change from baseline in pain catastrophizing
Prazo: at 5 weeks
Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
at 5 weeks
Change from baseline in pain catastrophizing
Prazo: at 10 weeks
Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
at 10 weeks
Change from baseline in pain catastrophizing
Prazo: at one-year
Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
at one-year
Change from baseline in coping strategies
Prazo: at one-year
Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
at one-year
Change from baseline in coping strategies
Prazo: at 5 weeks
Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
at 5 weeks
Change from baseline in coping strategies
Prazo: at 10 weeks
Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
at 10 weeks
Change from baseline in pain acceptance
Prazo: at 5 weeks
Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
at 5 weeks
Change from baseline in pain acceptance
Prazo: at 10 weeks
Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
at 10 weeks
Change from baseline in pain acceptance
Prazo: at one-year
Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
at one-year
Change from baseline in self efficacy
Prazo: at 5 weeks
Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version
at 5 weeks
Change from baseline in self efficacy
Prazo: at 10 weeks
Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version
at 10 weeks
Change from baseline in self efficacy
Prazo: at one-year
Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version
at one-year
Treatment credibility rating
Prazo: Baseline only
Self reported treatment credibility, Treatment Credibility Scale (TCS), Swedish version
Baseline only

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Cadeira de estudo: Gerhard Andersson, Professor, Linkoeping University
  • Cadeira de estudo: Torsten Gordh, Professor, Uppsala University
  • Diretor de estudo: Monica Buhrman, PhD, Uppsala 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 (Real)

13 de setembro de 2016

Conclusão Primária (Real)

1 de maio de 2017

Conclusão do estudo (Real)

1 de dezembro de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

1 de setembro de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de outubro de 2017

Primeira postagem (Real)

20 de outubro de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de maio de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de maio de 2020

Última verificação

1 de maio de 2020

Mais Informações

Termos relacionados a este estudo

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

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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