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

25 mai 2020 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

187

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

16 ans à 70 ans (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Internet-delivered therapy
10 week, guided and individually tailored internet-delivered cognitive behavioral therapy.
Aucune intervention: Wait list control group
Wait list control group, receives treatment at later point.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from baseline in depressive symptoms
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from baseline in anxiety sensitivity
Délai: at 10 weeks
Self reported anxiety sensitivity, Anxiety Sensitivity Index (ASI), Swedish version, 16 items
at 10 weeks
Change from baseline in anxiety sensitivity
Délai: 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
Délai: 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
Délai: 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
Délai: at 10 weeks
Self reported pain disability, Pain Disability Index (PDI), Swedish version, 7 items
at 10 weeks
Change from baseline in pain disability
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline only
Self reported fear of movement, Tampa Scale of Kinesiophobia (TSK), Swedish version, 17 items
Baseline only
Change from baseline in insomnia symptoms
Délai: at 10 weeks
Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version
at 10 weeks
Change from baseline in insomnia symptoms
Délai: at one-year
Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version
at one-year
Change from baseline in PTSD symptoms
Délai: 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
Délai: 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
Délai: at 10 weeks
Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version
at 10 weeks
Change from baseline in stress
Délai: at one-year
Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version
at one-year
Change from baseline in GAD-symptoms
Délai: at 10 weeks
Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version
at 10 weeks
Change from baseline in GAD-symptoms
Délai: at one-year
Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version
at one-year
Change from baseline in pain catastrophizing
Délai: at 5 weeks
Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
at 5 weeks
Change from baseline in pain catastrophizing
Délai: at 10 weeks
Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
at 10 weeks
Change from baseline in pain catastrophizing
Délai: at one-year
Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
at one-year
Change from baseline in coping strategies
Délai: at one-year
Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
at one-year
Change from baseline in coping strategies
Délai: at 5 weeks
Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
at 5 weeks
Change from baseline in coping strategies
Délai: at 10 weeks
Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
at 10 weeks
Change from baseline in pain acceptance
Délai: at 5 weeks
Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
at 5 weeks
Change from baseline in pain acceptance
Délai: at 10 weeks
Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
at 10 weeks
Change from baseline in pain acceptance
Délai: at one-year
Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
at one-year
Change from baseline in self efficacy
Délai: 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
Délai: 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
Délai: at one-year
Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version
at one-year
Treatment credibility rating
Délai: Baseline only
Self reported treatment credibility, Treatment Credibility Scale (TCS), Swedish version
Baseline only

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chaise d'étude: Gerhard Andersson, Professor, Linkoeping University
  • Chaise d'étude: Torsten Gordh, Professor, Uppsala University
  • Directeur d'études: Monica Buhrman, PhD, Uppsala University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

13 septembre 2016

Achèvement primaire (Réel)

1 mai 2017

Achèvement de l'étude (Réel)

1 décembre 2018

Dates d'inscription aux études

Première soumission

1 septembre 2017

Première soumission répondant aux critères de contrôle qualité

17 octobre 2017

Première publication (Réel)

20 octobre 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 mai 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 mai 2020

Dernière vérification

1 mai 2020

Plus d'information

Termes liés à cette étude

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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