Smart Phone ACT Treatment for Adults With Longstanding Pain - a Pilot Study
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The aims are to test feasibility and preliminary effects of a smart phone delivered ACT
      treatment for adults with longstanding pain.

      The hypotheses are that

        1. ACTsmart will be a feasible and accessable treatment delivery form

        2. ACTsmart will improve function and quality of life
    

Detailed description: 
      Chronic pain affects 12-30% of the population and often results in depression, disability,
      and reduced daily function and quality of life. Medical strategies are often ineffective or
      insufficient to alleviate symptoms and increase functioning. Instead, the empirical support
      for cognitive behavior therapy (CBT) is today well established, and such interventions are
      commonly seen as critically important for patients with chronic pain. However, modest effects
      sizes calls for further improvements. Recent developments within CBT, particularly Acceptance
      and Commitment Therapy (ACT), have suggested the utility of acceptance and mindfulness
      strategies to manage pain and distress. The body of evidence for ACT has grown rapidly during
      the past decade, and ACT is today listed by the American Psychological Association as a
      treatment for chronic pain, with strong empirical support.

      Internet-delivered ACT Despite the increased empirical support for ACT the availability is
      still very limited, and a large number of patients do not receive this treatment. In other
      domains, the accessibility of empirically supported treatments has increased during the past
      decade due to the development of methods to deliver the treatment via internet. For example,
      a large number of studies illustrate the utility of internet-delivered CBT for anxiety,
      insomnia and depression, with treatment effects similar to those obtained in studies with
      face-to-face treatment. Few studies have yet evaluated internet-delivered ACT (iACT) for
      chronic pain, but a recent pilot study from our group with participants suffering from
      fibromyalgia (n=41) illustrated very promising results that warrant further studies to
      evaluate the effects of this treatment.

      To make treatment more accessible and present in patients' daily life we will use a smart
      phone application to deliver treatment.

      Recruitment Patients will be recruited through self referral. Information regarding the study
      will be provided through newspapers and social media, as well as in direct communication with
      pain clinics and primary care units, including instructions regarding e.g. eligibility and
      how to sign up. Once patients have been found eligible and expressed interest in study
      participation they will be assessed by a psychologist, and when needed by a pain physician,
      via semi-structured interviews to confirm eligibility and to ensure that the patient meet the
      study criteria. Informed consent is obtained from all participants prior to the assessment.

      Statistical methods Evaluations of treatment effects are primarily based on intent-to-treat
      analyses. The statistical approach will primarily be based on linear multilevel modeling
      (LMM), which takes into account dependencies between repeated measures and differences
      between patients in pre-treatment status and treatment response (i.e. random effects
      modeling) and also provide means of handling missing data. More traditional methods, such as
      ANOVA and hierarchical regression, may also be utilized when appropriate.

      Interviews Evaluations of feasibility and as a base for further development of the smart
      phone application will be done via semi structured interviews during and after treatment
      period.
    

Intervention name(s): ACTsmart
Intervention type(s): Behavioral
Intervention description(s): Participant receive ACT treatment via a smart phone application, including psychologist support via a message function within the application.
Treatment content is divided into four modules:
education about pain behaviors, exposure and acceptance and commitment therapy
education about pain physiology
exercises on changing behaviors, acceptance, mindfulness, defusion and exposure
value based exposure in the participant's daily life
Intervention model: Single Group Assignment
Intervention model description: Pilot study of treatment delivery in a new format.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acceptance and Commitment therapy; ACT; CBT; Smart phone; Internet; Intervention