Internet-delivered ACT for Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The overall aim of the present study is to evaluate an internet-delivered Acceptance and
      Commitment therapy treatment (iACT) for patients with chronic pain. More specifically, the
      study will evaluate if 1) iACT is effective in improving functioning and quality of life in
      comparison to a waitlist condition, 2) if iACT is cost-effective, 3) factors that influence
      treatment outcome (i.e. predictors, moderators or characteristics of treatment responders),
      4) if psychological variables mediates the effects of treatment on outcome, and 5) if
      subgroups of patients varies in change processes (i.e. moderated mediation).

      The main hypothesis is that iACT will improve functioning and quality of life.
    

Detailed description: 
      Chronic pain affects 12-30% of the population and often results in depression, disability,
      and reduced 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.

      Moderators and mediators of treatment outcome

      If iACT shows to be effective, it is vital to identify for whom this treatment works. For
      example, it is possible that factors such as age, pain duration or depression may moderate
      the effects of treatment. Also, it is likely that some individuals who respond well to
      regular face-to-face treatment do not benefit from internet-delivered interventions.
      Furthermore, recent studies have shown that acceptance of pain and distress may be a more
      important mediator of change than e.g. pain intensity, catastrophizing or anxiety. However,
      no study has to our knowledge yet explored if subgroups of patients (e.g. men and women)
      improve via different change processes (i.e. moderated mediation). More information regarding
      moderators and mediators of change will make it possible to adjust and tailor interventions
      to meet specific individual needs, and thereby increase the effects of treatment.

      Recruitment

      Patients will be recruited through self referral. Thus, 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. Analyses of change processes (mediation,
      moderation, moderated mediation) will follow guidelines and recommendations (e.g.
      cross-product of coefficients approach, bootstrapping). The main health economic outcomes
      will be the incremental cost-effectiveness ratio, which is a measure of the relationship
      between the cost of the treatment and the incremental value it provides in terms of
      functioning, compared to the control condition.
    

Intervention name(s): Internet delivered Acceptance and Commitment therapy; Waiting list control condition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The main component in the treatment is exposure to symptoms and feared situations. The iACT program is adapted from the evidence based face-to-face treatment at the Behavioral Medicine unit at Karolinska University Hospital. The iACT program has a different structure but is equal in content to face-to-face treatment, and is to be completed within ten weeks. Participants receive texts, audio files, movies and exercises and have online contact with their psychologist via an internet platform or a smart phone application. The treatment aims to encourage valued behaviors in the presence of inner discomfort.; After a ten week wait list period, the control condition receive same treatment as the intervention group, but without therapist support.
Other intervention name(s): iACT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment