- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03316846
Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Psychiatric Distress (TIPPS)
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
Uppland
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Uppsala, Uppland, Schweden, 75236
- Department of Psychology, Uppsala University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Internet-delivered therapy
10 week, guided and individually tailored internet-delivered cognitive behavioral therapy.
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Kein Eingriff: Wait list control group
Wait list control group, receives treatment at later point.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change from baseline in depressive symptoms
Zeitfenster: at 10 weeks
|
Self reported change in depressive symptoms, Montgomery-Åsberg Depression Rating Scale (MADRS-S) Swedish version, 9 items
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at 10 weeks
|
Change from baseline in depressive symptoms
Zeitfenster: at one-year
|
Self reported change in depressive symptoms, Montgomery-Åsberg Depression Rating Scale (MADRS-S) Swedish version, 9 items
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at one-year
|
Change from baseline in psychosocial consequences of pain
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change from baseline in anxiety sensitivity
Zeitfenster: at 10 weeks
|
Self reported anxiety sensitivity, Anxiety Sensitivity Index (ASI), Swedish version, 16 items
|
at 10 weeks
|
Change from baseline in anxiety sensitivity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: at 10 weeks
|
Self reported pain disability, Pain Disability Index (PDI), Swedish version, 7 items
|
at 10 weeks
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Change from baseline in pain disability
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: at one-year
|
Self reported quality of life, Quality of Life Inventory (QOLI), Swedish version, 7 items
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at one-year
|
Fear of pain due to movement
Zeitfenster: Baseline only
|
Self reported fear of movement, Tampa Scale of Kinesiophobia (TSK), Swedish version, 17 items
|
Baseline only
|
Change from baseline in insomnia symptoms
Zeitfenster: at 10 weeks
|
Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version
|
at 10 weeks
|
Change from baseline in insomnia symptoms
Zeitfenster: at one-year
|
Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version
|
at one-year
|
Change from baseline in PTSD symptoms
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: at 10 weeks
|
Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version
|
at 10 weeks
|
Change from baseline in stress
Zeitfenster: at one-year
|
Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version
|
at one-year
|
Change from baseline in GAD-symptoms
Zeitfenster: at 10 weeks
|
Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version
|
at 10 weeks
|
Change from baseline in GAD-symptoms
Zeitfenster: at one-year
|
Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version
|
at one-year
|
Change from baseline in pain catastrophizing
Zeitfenster: at 5 weeks
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Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
|
at 5 weeks
|
Change from baseline in pain catastrophizing
Zeitfenster: at 10 weeks
|
Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
|
at 10 weeks
|
Change from baseline in pain catastrophizing
Zeitfenster: at one-year
|
Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
|
at one-year
|
Change from baseline in coping strategies
Zeitfenster: at one-year
|
Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
|
at one-year
|
Change from baseline in coping strategies
Zeitfenster: at 5 weeks
|
Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
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at 5 weeks
|
Change from baseline in coping strategies
Zeitfenster: at 10 weeks
|
Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
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at 10 weeks
|
Change from baseline in pain acceptance
Zeitfenster: at 5 weeks
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Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
|
at 5 weeks
|
Change from baseline in pain acceptance
Zeitfenster: at 10 weeks
|
Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
|
at 10 weeks
|
Change from baseline in pain acceptance
Zeitfenster: at one-year
|
Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
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at one-year
|
Change from baseline in self efficacy
Zeitfenster: at 5 weeks
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Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version
|
at 5 weeks
|
Change from baseline in self efficacy
Zeitfenster: 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
Zeitfenster: at one-year
|
Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version
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at one-year
|
Treatment credibility rating
Zeitfenster: Baseline only
|
Self reported treatment credibility, Treatment Credibility Scale (TCS), Swedish version
|
Baseline only
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienstuhl: Gerhard Andersson, Professor, Linkoeping University
- Studienstuhl: Torsten Gordh, Professor, Uppsala University
- Studienleiter: Monica Buhrman, PhD, Uppsala University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 140371
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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