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

25 maja 2020 zaktualizowane przez: 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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

187

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

16 lat do 70 lat (Dziecko, Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Internet-delivered therapy
10 week, guided and individually tailored internet-delivered cognitive behavioral therapy.
Brak interwencji: Wait list control group
Wait list control group, receives treatment at later point.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline in depressive symptoms
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Współpracownicy

Śledczy

  • Krzesło do nauki: Gerhard Andersson, Professor, Linkoeping University
  • Krzesło do nauki: Torsten Gordh, Professor, Uppsala University
  • Dyrektor Studium: Monica Buhrman, PhD, Uppsala University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

13 września 2016

Zakończenie podstawowe (Rzeczywisty)

1 maja 2017

Ukończenie studiów (Rzeczywisty)

1 grudnia 2018

Daty rejestracji na studia

Pierwszy przesłany

1 września 2017

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 października 2017

Pierwszy wysłany (Rzeczywisty)

20 października 2017

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

27 maja 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

25 maja 2020

Ostatnia weryfikacja

1 maja 2020

Więcej informacji

Terminy związane z tym badaniem

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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Badania kliniczne na Internet-Delivered Cognitive Behavioral Therapy

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