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

25. mai 2020 oppdatert av: 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.

Studieoversikt

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

187

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

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

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Internet-delivered therapy
10 week, guided and individually tailored internet-delivered cognitive behavioral therapy.
Ingen inngripen: Wait list control group
Wait list control group, receives treatment at later point.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. september 2016

Primær fullføring (Faktiske)

1. mai 2017

Studiet fullført (Faktiske)

1. desember 2018

Datoer for studieregistrering

Først innsendt

1. september 2017

Først innsendt som oppfylte QC-kriteriene

17. oktober 2017

Først lagt ut (Faktiske)

20. oktober 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. mai 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. mai 2020

Sist bekreftet

1. mai 2020

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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