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

25. maj 2020 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

187

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

16 år til 70 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Internet-delivered therapy
10 week, guided and individually tailored internet-delivered cognitive behavioral therapy.
Ingen indgriben: Wait list control group
Wait list control group, receives treatment at later point.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in depressive symptoms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Studiestol: Gerhard Andersson, Professor, Linkoeping University
  • Studiestol: Torsten Gordh, Professor, Uppsala University
  • Studieleder: Monica Buhrman, PhD, Uppsala University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. september 2016

Primær færdiggørelse (Faktiske)

1. maj 2017

Studieafslutning (Faktiske)

1. december 2018

Datoer for studieregistrering

Først indsendt

1. september 2017

Først indsendt, der opfyldte QC-kriterier

17. oktober 2017

Først opslået (Faktiske)

20. oktober 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. maj 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. maj 2020

Sidst verificeret

1. maj 2020

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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