Clinical trial NCT03316846: Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Psychiatric Distress
Official title: Tailored Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Comorbid Psychiatric Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Depressive Symptoms
Anxiety
Stress, Psychological
Keywords: Chronic Pain
Depression
Anxiety
Stress
iCBT
Cognitive behavioral therapy
Internet delivered
Tailored treatment
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
First posted: 2017-10-20
Enrollment: 187
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change from baseline in depressive symptoms
timeFrame: at 10 weeks
measure: Change from baseline in depressive symptoms
timeFrame: at one-year
measure: Change from baseline in psychosocial consequences of pain
timeFrame: at 10 weeks
measure: Change from baseline in psychosocial consequences of pain
timeFrame: at one-year
Secondary outcomes:
measure: Change from baseline in anxiety sensitivity
timeFrame: at 10 weeks
measure: Change from baseline in anxiety sensitivity
timeFrame: at one-year
measure: Change from baseline in symptoms of depression and anxiety
timeFrame: at 10 weeks
measure: Change from baseline in symptoms of depression and anxiety
timeFrame: at one-year
measure: Change from baseline in pain disability
timeFrame: at 10 weeks
measure: Change from baseline in pain disability
timeFrame: at one-year
measure: Change from baseline in quality of life
timeFrame: at 10 weeks
measure: Change from baseline in quality of life
timeFrame: at one-year
measure: Fear of pain due to movement
timeFrame: Baseline only
measure: Change from baseline in insomnia symptoms
timeFrame: at 10 weeks
measure: Change from baseline in insomnia symptoms
timeFrame: at one-year
measure: Change from baseline in PTSD symptoms
timeFrame: at 10 weeks
measure: Change from baseline in PTSD symptoms
timeFrame: at one-year
measure: Change from baseline in stress
timeFrame: at 10 weeks
measure: Change from baseline in stress
timeFrame: at one-year
measure: Change from baseline in GAD-symptoms
timeFrame: at 10 weeks
measure: Change from baseline in GAD-symptoms
timeFrame: at one-year
measure: Change from baseline in pain catastrophizing
timeFrame: at 5 weeks
measure: Change from baseline in pain catastrophizing
timeFrame: at 10 weeks
measure: Change from baseline in pain catastrophizing
timeFrame: at one-year
measure: Change from baseline in coping strategies
timeFrame: at one-year
measure: Change from baseline in coping strategies
timeFrame: at 5 weeks
measure: Change from baseline in coping strategies
timeFrame: at 10 weeks
measure: Change from baseline in pain acceptance
timeFrame: at 5 weeks
measure: Change from baseline in pain acceptance
timeFrame: at 10 weeks
measure: Change from baseline in pain acceptance
timeFrame: at one-year
measure: Change from baseline in self efficacy
timeFrame: at 5 weeks
measure: Change from baseline in self efficacy
timeFrame: at 10 weeks
measure: Change from baseline in self efficacy
timeFrame: at one-year
measure: Treatment credibility rating
timeFrame: Baseline only
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Department of Psychology, Uppsala University
state: Uppland
Study officials:
affiliation: Uppsala University
name: Monica Buhrman, PhD
role: STUDY_DIRECTOR
affiliation: Linkoeping University
name: Gerhard Andersson, Professor
role: STUDY_CHAIR
affiliation: Uppsala University
name: Torsten Gordh, Professor
role: STUDY_CHAIR
References: