Online Mindfulness-based Intervention to Prevent Chronic Pain
Condition: Pain, Postoperative; Chronic Pain; Pain Catastrophizing; Pain, Acute
MeSH terms: Chronic Pain; Pain, Postoperative; Acute Pain
Study type: Interventional

Summary: 
      Cardiac and orthopedic surgeries are frequent procedures. However, pain after a major surgery
      may become chronic (lasting >3 months) in adults. Once discharged from the hospital, patients
      are at risk for chronic post-surgical pain (CPSP) and prolonged opioid use, as they become
      isolated with high levels of pain. Psychological risk and protective factors such as
      pain-related catastrophic thoughts and pain acceptance will determine their ability to cope
      and their opioid use, which makes a support for pain self-management crucial. There is
      limited research on psychological interventions for pain in the subacute/rehabilitation phase
      after major surgery. Further, these interventions are demanding and not tailored. Previous
      work from the Principal Investigator in the acute/hospitalization phase shows that a brief,
      Web-based intervention tailored to modifiable psychological factors may modulate these and
      reduce postoperative pain interference. Recently, studies on mindfulness-based cognitive
      therapy (MBCT) have multiplied regarding their potential effect on pain acceptance and
      catastrophic thoughts. Brief, Web-based MBCT for the prevention of CPSP have not been
      examined. Therefore, a pilot test of a 4-week tailored, Web-based MBCT intervention for
      adults in the rehabilitation phase will be conducted by 1) assessing the
      acceptability/feasibility of the intervention; and 2) examining preliminary effects on pain
      intensity and pain interference with activities, as well as pain acceptance and catastrophic
      thoughts. This research is significant because it targets the trajectory of CPSP, a leading
      cause of disability and opioid misuse. This approach is innovative because it promotes pain
      self-management through the modulation of individual factors. If successful, the intervention
      could be expanded to numerous populations at risk for chronic pain.
    

Detailed description: 
      A single blinded pilot randomized controlled trial will be used to assess preliminary
      efficacy of the Web-based MBCT intervention following major surgery (Coronary Artery Bypass
      Grafting [CABG] or/and Valve Replacement [VR]; Total knee or hip replacement). An experienced
      research assistant (RA) will be responsible of participants' recruitment and informed consent
      procedures at the time of follow-up (usually 2 weeks after surgery). The study will be
      advertised on the rehabilitation units and surgeon's offices with posters and flyers . If
      interested, clinical team will contact the RA and inclusion criteria will be assessed. After
      having collected baseline measures, participants will be randomized into two groups by the
      principal investigator (PI): one receiving both the 4-week Web-based MBCT intervention and
      the usual care procedure (Experimental Group: EG), the other one receiving solely one
      standardized educational online session and the usual care procedure (Control Group: CG).
      Participants from the CG will be given the opportunity to receive the entire intervention
      once the study will be completed.

      Permuted-block randomization with an allocation ratio of 1:1 will be used to generate a list
      through computer software. The list and envelopes will be prepared by a PI's colleague who
      will not be involved in this study. The RA who will be responsible of the entire data
      collection will be blinded to patient group assignment.

      All participants will complete baseline measures via a telephone interview or a Qualtrics®
      survey (T0). Usual socio-demographic variables --i.e., age, sex, civil status, living
      conditions, education level, and employment status will be assessed. Considering the
      reciprocity between pain and, anxiety and depression, measures will be taken with the PHQ-4
      before intervention (T0), and after intervention (T1). Presence of chronic pain before
      surgery will be documented as well. Analgesic medication intake will be documented at all
      time points. The protocol will favor an intention-to-treat approach for the analysis of
      results. Participants' flow will be reported according to the CONSORT guidelines for
      psychological interventions. Student's t-tests or chi-square tests will be performed for each
      socio-demographic, medico-surgical and baseline psychological variables to assure that
      equivalence of groups was obtained through randomization, although this procedure is not
      mandatory. The statistical analysis will be mostly descriptive (mean, standard deviation for
      continuous outcomes and, frequency and proportion for categorical outcomes) with 95%
      confidence intervals when appropriate. Pain intensity, pain interference, mindfulness, pain
      acceptance, pain-related catastrophic thoughts, and psychological well-being scores will be
      summarized using descriptive statistics presented per group at each time point. Further,
      treatment effect will be estimated and presented with 95% CI at each time point. A first set
      of exploratory analysis will be carried out to compare the evolution of pain intensity, pain
      interference, mindfulness, pain acceptance, pain-related catastrophic thoughts, and
      psychological well-being in each group through the use of two-way ANOVA with repeated
      measures (pre-intervention, post-intervention). A second set of analyses will assess the
      impact of the intervention on the prevalence and severity of CPSP (pain intensity and
      interference, mindfulness, pain acceptance, pain-related catastrophic thoughts, and
      psychological well-being). Repeated measures ANOVA and repeated measures logistic regression
      will be performed to compare groups for illustrative purposes since the study is not powered
      to show statistical significance. An alpha level of significance of 0,05 will be used for all
      analyses. If interactions are found (p<0,05), post-hoc comparisons will be performed. Lastly,
      qualitative data obtained from individual interviews will be content analyzed.
    

Intervention name(s): Online mindfulness-based cognitive therapy; Online standardized education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The first session will first focus on providing feedback regarding post-surgical pain. The second session will focus on teaching mindfulness strategies. The third session will focus on practicing one of the two strategies. Of note, sessions 2 and 3 will start with cognitive restructuring strategies for the moderate-high risk profile patients. The 4th session consists in a booster providing feedback and reminders about cognitive reactions to pain and mindfulness meditation. The participants will be asked to practice meditation 5 days a week, for a total of 4 weeks; One 15-minute educational session on postoperative pain, the relationship between pain, thoughts and emotions and brief overview of strategies.
Other intervention name(s): Online MBCT
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2-arm pilot RCT
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: postoperative pain; mindfulness; chronic pain