Optimizing Psychological Treatment for Pain After Breast Cancer: A Pilot Study
Condition: Pain, Chronic; Breast Cancer
MeSH terms: Breast Neoplasms; Chronic Pain
Study type: Interventional

Summary: 
      The present study is a pilot study that aims to evaluate the feasibility, validity, and
      preliminary efficacy of three psychological treatment components for pain after breast
      cancer, which will be evaluated in a larger trial following completion of the present pilot
      study.
    

Detailed description: 
      The present pilot study is a precursor for a following larger trial and aims to evaluate the
      i) feasibility, ii) validity, and iii) preliminary efficacy of the three treatment components
      that will be further investigated in a subsequent larger trial. The present pilot study will
      employ the same design as will be used in the subsequent larger trial, namely the Multiphase
      Optimization Strategy (MOST). Specifically, in the subsequent larger trial, MOST will be used
      to evaluate the efficacy and change processes of three psychological treatment components
      selected from so-called "third wave" cognitive therapies (CTs), which have been shown to be
      efficacious in the treatment of pain after breast cancer.

      The overall hypothesis is that the selected third wave CT components will target key
      maintaining psychological factors in pain, thus leading to reductions in the primary outcomes
      of pain intensity and -interference. Specifically, we hypothesize that:

        1. Mindful attention practices will increase attentional control (i.e., the ability to
           intentionally focus and intentionally shift one's attention), thereby reducing pain
           hypervigilance, leading to reductions in pain intensity and -interference.

        2. Decentering practices will reduce fusion with thoughts (i.e., getting caught up in one's
           thoughts and acting automatically in response to thoughts), thereby reducing pain
           catastrophizing, leading to reductions in pain intensity and -interference.

        3. Values and committed action (i.e., behavior linked to values and goals) will increase
           acceptance of discomfort and reduce avoidant behavior, leading to reductions in pain
           intensity and -interference.
    

Intervention name(s): Mindful attention; Decentering; Value-based action
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The Mindful attention treatment component consists of a breathing exercise and is operationalized as two sessions (1 hour each) delivered over two weeks, i.e., one session per week, with homework between sessions. Sessions will be delivered online.; The Decentering treatment component consists of a guided imagery exercise and is operationalized as two sessions (1 hour each) delivered over two weeks, i.e., one session per week, with homework between sessions. Sessions will be delivered online.; The Values and committed action treatment component consists of identification of personal values and committed action, and is operationalized as two sessions (1 hour each) delivered over two weeks, i.e., one session per week, with homework between sessions. Sessions will be delivered online.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The study uses a 2^3 factorial design, randomizing participants to 8 experimental conditions
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer; Pain; Third wave cognitive therapy; Mindful attention; Decentering; Values and committed action; The Multiphase Optimization Strategy (MOST); Psychological pain treatment; Treatment mediators