Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Psychiatric Distress
Condition: Chronic Pain; Depressive Symptoms; Anxiety; Stress, Psychological
MeSH terms: Chronic Pain; Depression; Stress, Psychological
Study type: Interventional

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.
    

Intervention name(s): Internet-Delivered Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Pain; Depression; Anxiety; Stress; iCBT; Cognitive behavioral therapy; Internet delivered; Tailored treatment