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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tailored Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Comorbid Psychiatric Distress

Conditions
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Chronic Pain, Depressive Symptoms, Anxiety, Stress, Psychological

Intervention / Treatment
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* Behavioral: Internet-Delivered Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-delivered therapy<br>10 week, guided and individually tailored internet-delivered cognitive behavioral therapy. | Behavioral: Internet-Delivered Cognitive Behavioral Therapy<br> <br> |
| No Intervention: Wait list control group<br>Wait list control group, receives treatment at later point. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in depressive symptoms | 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 | 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 | 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 | Self reported psychosocial consequences of pain, West Haven-Yale Multidimensional Pain Inventory (WHY/MPI-S part 1), Swedish version, 22 items | at one-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in anxiety sensitivity | Self reported anxiety sensitivity, Anxiety Sensitivity Index (ASI), Swedish version, 16 items | at 10 weeks | 
| Change from baseline in anxiety sensitivity | Self reported anxiety sensitivity, Anxiety Sensitivity Index (ASI), Swedish version, 16 items | at one-year | 
| 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 | at 10 weeks | 
| 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 | at one-year | 
| Change from baseline in pain disability | Self reported pain disability, Pain Disability Index (PDI), Swedish version, 7 items | at 10 weeks | 
| Change from baseline in pain disability | Self reported pain disability, Pain Disability Index (PDI), Swedish version, 7 items | at one-year | 
| Change from baseline in quality of life | Self reported quality of life, Quality of Life Inventory (QOLI), Swedish version, 7 items | at 10 weeks | 
| Change from baseline in quality of life | Self reported quality of life, Quality of Life Inventory (QOLI), Swedish version, 7 items | at one-year | 
| Fear of pain due to movement | Self reported fear of movement, Tampa Scale of Kinesiophobia (TSK), Swedish version, 17 items | Baseline only | 
| Change from baseline in insomnia symptoms | Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version | at 10 weeks | 
| Change from baseline in insomnia symptoms | Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version | at one-year | 
| Change from baseline in PTSD symptoms | Self reported PTSD symptoms, Post-Traumatic Stress Disorder checklist 5 (PCL-5), Swedish version | at 10 weeks | 
| Change from baseline in PTSD symptoms | Self reported PTSD symptoms, Post-Traumatic Stress Disorder checklist 5 (PCL-5), Swedish version | at one-year | 
| Change from baseline in stress | Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version | at 10 weeks | 
| Change from baseline in stress | Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version | at one-year | 
| Change from baseline in GAD-symptoms | Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version | at 10 weeks | 
| Change from baseline in GAD-symptoms | Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version | at one-year | 
| Change from baseline in pain catastrophizing | Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version | at 5 weeks | 
| Change from baseline in pain catastrophizing | Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version | at 10 weeks | 
| Change from baseline in pain catastrophizing | Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version | at one-year | 
| Change from baseline in coping strategies | Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version | at one-year | 
| Change from baseline in coping strategies | Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version | at 5 weeks | 
| Change from baseline in coping strategies | Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version | at 10 weeks | 
| Change from baseline in pain acceptance | Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version | at 5 weeks | 
| Change from baseline in pain acceptance | Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version | at 10 weeks | 
| Change from baseline in pain acceptance | Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version | at one-year | 
| Change from baseline in self efficacy | Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version | at 5 weeks | 
| Change from baseline in self efficacy | Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version | at 10 weeks | 
| Change from baseline in self efficacy | Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version | at one-year | 
| Treatment credibility rating | Self reported treatment credibility, Treatment Credibility Scale (TCS), Swedish version | Baseline only | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pain, Depression, Anxiety, Stress, iCBT, Cognitive behavioral therapy, Internet delivered, Tailored treatment