Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Psychiatric Distress (TIPPS)
Primary Purpose
Chronic Pain, Depressive Symptoms, Anxiety
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-Delivered Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Pain, Depression, Anxiety, Stress, iCBT, Cognitive behavioral therapy, Internet delivered, Tailored treatment
Eligibility Criteria
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)
Sites / Locations
- Department of Psychology, Uppsala University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Internet-delivered therapy
Wait list control group
Arm Description
10 week, guided and individually tailored internet-delivered cognitive behavioral therapy.
Wait list control group, receives treatment at later point.
Outcomes
Primary Outcome Measures
Change from baseline in depressive symptoms
Self reported change in depressive symptoms, Montgomery-Åsberg Depression Rating Scale (MADRS-S) Swedish version, 9 items
Change from baseline in depressive symptoms
Self reported change in depressive symptoms, Montgomery-Åsberg Depression Rating Scale (MADRS-S) Swedish version, 9 items
Change from baseline in psychosocial consequences of pain
Self reported psychosocial consequences of pain, West Haven-Yale Multidimensional Pain Inventory (WHY/MPI-S part 1), Swedish version, 22 items
Change from baseline in psychosocial consequences of pain
Self reported psychosocial consequences of pain, West Haven-Yale Multidimensional Pain Inventory (WHY/MPI-S part 1), Swedish version, 22 items
Secondary Outcome Measures
Change from baseline in anxiety sensitivity
Self reported anxiety sensitivity, Anxiety Sensitivity Index (ASI), Swedish version, 16 items
Change from baseline in anxiety sensitivity
Self reported anxiety sensitivity, Anxiety Sensitivity Index (ASI), Swedish version, 16 items
Change from baseline in symptoms of depression and anxiety
Self reported symptoms of depression and anxiety, Hospital Anxiety and Depression Scale (HADS), Swedish version, 14 items
Change from baseline in symptoms of depression and anxiety
Self reported symptoms of depression and anxiety, Hospital Anxiety and Depression Scale (HADS), Swedish version, 14 items
Change from baseline in pain disability
Self reported pain disability, Pain Disability Index (PDI), Swedish version, 7 items
Change from baseline in pain disability
Self reported pain disability, Pain Disability Index (PDI), Swedish version, 7 items
Change from baseline in quality of life
Self reported quality of life, Quality of Life Inventory (QOLI), Swedish version, 7 items
Change from baseline in quality of life
Self reported quality of life, Quality of Life Inventory (QOLI), Swedish version, 7 items
Fear of pain due to movement
Self reported fear of movement, Tampa Scale of Kinesiophobia (TSK), Swedish version, 17 items
Change from baseline in insomnia symptoms
Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version
Change from baseline in insomnia symptoms
Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version
Change from baseline in PTSD symptoms
Self reported PTSD symptoms, Post-Traumatic Stress Disorder checklist 5 (PCL-5), Swedish version
Change from baseline in PTSD symptoms
Self reported PTSD symptoms, Post-Traumatic Stress Disorder checklist 5 (PCL-5), Swedish version
Change from baseline in stress
Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version
Change from baseline in stress
Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version
Change from baseline in GAD-symptoms
Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version
Change from baseline in GAD-symptoms
Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version
Change from baseline in pain catastrophizing
Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
Change from baseline in pain catastrophizing
Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
Change from baseline in pain catastrophizing
Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
Change from baseline in coping strategies
Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
Change from baseline in coping strategies
Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
Change from baseline in coping strategies
Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
Change from baseline in pain acceptance
Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
Change from baseline in pain acceptance
Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
Change from baseline in pain acceptance
Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
Change from baseline in self efficacy
Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version
Change from baseline in self efficacy
Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version
Change from baseline in self efficacy
Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version
Treatment credibility rating
Self reported treatment credibility, Treatment Credibility Scale (TCS), Swedish version
Full Information
NCT ID
NCT03316846
First Posted
September 1, 2017
Last Updated
May 25, 2020
Sponsor
Uppsala University
Collaborators
Uppsala University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03316846
Brief Title
Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Psychiatric Distress
Acronym
TIPPS
Official Title
Tailored Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Comorbid Psychiatric Distress
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 13, 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Uppsala University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Depressive Symptoms, Anxiety, Stress, Psychological
Keywords
Chronic Pain, Depression, Anxiety, Stress, iCBT, Cognitive behavioral therapy, Internet delivered, Tailored treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet-delivered therapy
Arm Type
Experimental
Arm Description
10 week, guided and individually tailored internet-delivered cognitive behavioral therapy.
Arm Title
Wait list control group
Arm Type
No Intervention
Arm Description
Wait list control group, receives treatment at later point.
Intervention Type
Behavioral
Intervention Name(s)
Internet-Delivered Cognitive Behavioral Therapy
Primary Outcome Measure Information:
Title
Change from baseline in depressive symptoms
Description
Self reported change in depressive symptoms, Montgomery-Åsberg Depression Rating Scale (MADRS-S) Swedish version, 9 items
Time Frame
at 10 weeks
Title
Change from baseline in depressive symptoms
Description
Self reported change in depressive symptoms, Montgomery-Åsberg Depression Rating Scale (MADRS-S) Swedish version, 9 items
Time Frame
at one-year
Title
Change from baseline in psychosocial consequences of pain
Description
Self reported psychosocial consequences of pain, West Haven-Yale Multidimensional Pain Inventory (WHY/MPI-S part 1), Swedish version, 22 items
Time Frame
at 10 weeks
Title
Change from baseline in psychosocial consequences of pain
Description
Self reported psychosocial consequences of pain, West Haven-Yale Multidimensional Pain Inventory (WHY/MPI-S part 1), Swedish version, 22 items
Time Frame
at one-year
Secondary Outcome Measure Information:
Title
Change from baseline in anxiety sensitivity
Description
Self reported anxiety sensitivity, Anxiety Sensitivity Index (ASI), Swedish version, 16 items
Time Frame
at 10 weeks
Title
Change from baseline in anxiety sensitivity
Description
Self reported anxiety sensitivity, Anxiety Sensitivity Index (ASI), Swedish version, 16 items
Time Frame
at one-year
Title
Change from baseline in symptoms of depression and anxiety
Description
Self reported symptoms of depression and anxiety, Hospital Anxiety and Depression Scale (HADS), Swedish version, 14 items
Time Frame
at 10 weeks
Title
Change from baseline in symptoms of depression and anxiety
Description
Self reported symptoms of depression and anxiety, Hospital Anxiety and Depression Scale (HADS), Swedish version, 14 items
Time Frame
at one-year
Title
Change from baseline in pain disability
Description
Self reported pain disability, Pain Disability Index (PDI), Swedish version, 7 items
Time Frame
at 10 weeks
Title
Change from baseline in pain disability
Description
Self reported pain disability, Pain Disability Index (PDI), Swedish version, 7 items
Time Frame
at one-year
Title
Change from baseline in quality of life
Description
Self reported quality of life, Quality of Life Inventory (QOLI), Swedish version, 7 items
Time Frame
at 10 weeks
Title
Change from baseline in quality of life
Description
Self reported quality of life, Quality of Life Inventory (QOLI), Swedish version, 7 items
Time Frame
at one-year
Title
Fear of pain due to movement
Description
Self reported fear of movement, Tampa Scale of Kinesiophobia (TSK), Swedish version, 17 items
Time Frame
Baseline only
Title
Change from baseline in insomnia symptoms
Description
Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version
Time Frame
at 10 weeks
Title
Change from baseline in insomnia symptoms
Description
Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version
Time Frame
at one-year
Title
Change from baseline in PTSD symptoms
Description
Self reported PTSD symptoms, Post-Traumatic Stress Disorder checklist 5 (PCL-5), Swedish version
Time Frame
at 10 weeks
Title
Change from baseline in PTSD symptoms
Description
Self reported PTSD symptoms, Post-Traumatic Stress Disorder checklist 5 (PCL-5), Swedish version
Time Frame
at one-year
Title
Change from baseline in stress
Description
Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version
Time Frame
at 10 weeks
Title
Change from baseline in stress
Description
Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version
Time Frame
at one-year
Title
Change from baseline in GAD-symptoms
Description
Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version
Time Frame
at 10 weeks
Title
Change from baseline in GAD-symptoms
Description
Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version
Time Frame
at one-year
Title
Change from baseline in pain catastrophizing
Description
Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
Time Frame
at 5 weeks
Title
Change from baseline in pain catastrophizing
Description
Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
Time Frame
at 10 weeks
Title
Change from baseline in pain catastrophizing
Description
Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
Time Frame
at one-year
Title
Change from baseline in coping strategies
Description
Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
Time Frame
at one-year
Title
Change from baseline in coping strategies
Description
Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
Time Frame
at 5 weeks
Title
Change from baseline in coping strategies
Description
Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
Time Frame
at 10 weeks
Title
Change from baseline in pain acceptance
Description
Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
Time Frame
at 5 weeks
Title
Change from baseline in pain acceptance
Description
Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
Time Frame
at 10 weeks
Title
Change from baseline in pain acceptance
Description
Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
Time Frame
at one-year
Title
Change from baseline in self efficacy
Description
Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version
Time Frame
at 5 weeks
Title
Change from baseline in self efficacy
Description
Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version
Time Frame
at 10 weeks
Title
Change from baseline in self efficacy
Description
Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version
Time Frame
at one-year
Title
Treatment credibility rating
Description
Self reported treatment credibility, Treatment Credibility Scale (TCS), Swedish version
Time Frame
Baseline only
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Buhrman, PhD
Organizational Affiliation
Uppsala University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gerhard Andersson, Professor
Organizational Affiliation
Linkoeping University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Torsten Gordh, Professor
Organizational Affiliation
Uppsala University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Psychology, Uppsala University
City
Uppsala
State/Province
Uppland
ZIP/Postal Code
75236
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Psychiatric Distress
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