Study of Affect Induction for Lab Induced Pain in Healthy Undergraduates
Condition: Meditation; Pain; Mindfulness; Affect; Emotion Regulation
Study type: Interventional

Summary: 
      The goal of this clinical trial is to test if a mindfulness-enhanced positive affect
      induction (MPAI) works well to reduce pain intensity and pain unpleasantness from a cold
      water pain test in undergraduate college students who do not endorse ongoing medical or
      mental health diagnoses. The main questions it aims to answer are:

        -  Is the MPAI a feasible and acceptable psychological technique for managing brief pain?

        -  Does the MPAI work well to reduce pain intensity and unpleasantness from experimentally
           induced brief pain, compared to those using a breathing meditation or those instructed
           to respond naturally.

        -  Does using the MPAI work well to improve confidence in self-managing brief pain?

      Participants will be asked to complete questionnaires about their sleep, pain beliefs, and
      emotions after consenting to participate and at the end of the study session. They will then
      be randomized to either:

        -  Use the MPAI for managing pain induced by a cold water test (placing their hand in a
           container of cold water kept at approximately 5 degrees Celsius).

        -  Use a breathing meditation for managing pain induced by a cold water test (placing their
           hand in a container of cold water kept at approximately 5 degrees Celsius).

        -  Respond naturally to pain induced by a cold water test (placing their hand in a
           container of cold water kept at approximately 5 degrees Celsius).

      Researchers will compare the MPAI group to the breathing meditation and natural response
      groups to see if the MPAI group reports less pain from the cold water test and
    

Detailed description: 
      The purpose of the study is to assess the following aims:

      Aim 1: Examine the feasibility and acceptability of a mindfulness-enhanced positive affect
      induction (MPAI) for improving the experience of experimentally-induced pain.

      Aim 2: Examine the efficacy of the MPAI in reducing pain intensity and increasing pain
      tolerance.

      Aim 3: Examine change in self-efficacy in pain management from before and after using the
      MPAI.

      Recruitment:

      Participants will be recruited via the University of Colorado (CU) Denver Psychology
      Participant Pool website (Sona system), a resource for undergraduate Psychology students to
      participate in research projects. Interested participants will be provided
      inclusion/exclusion criteria and instructed to register for a study session only if they meet
      those criteria. Inclusion/exclusion criteria will be confirmed by study research assistants
      (RAs) during the informed consent process. Participants will receive course credit for
      participation in the study. If students do not wish to participate in the study, an
      alternative assignment will be available for equal credit.

      The target population will consist of a convenience sample of healthy undergraduate students
      at CU Denver. While this population does not generalize to populations with chronic pain, as
      this is the first study of this particular affect induction for pain, the primary goal is to
      assess general feasibility and efficacy, which may influence future research specific to
      chronic pain populations. The population will be randomized into three experimental groups:
      MPAI, breathing meditation (BM), and natural response (NR). The BM and NR groups will serve
      active comparison and control groups respectively. Each group will consist of 46 participants
      (N=138) based on power analyses accounting for medium effects found in similar studies. Final
      power analyses were conducted for planned ANCOVAs with f = 0.27, alpha = 0.05, and power =
      0.80.

      Phone screening will occur in instances in which participants contact study personnel via
      methods other than CU Denver's Sona system (e.g., via phone or email). Screening questions
      will not go beyond inclusion criteria listed on an approved study advertisement. No
      information will be recorded on specific inclusion/exclusion criteria met. Additionally,
      participants do not provide specific medical details during the consent process. Participants
      only indicate if they do or do not meet all inclusion/exclusion criteria.

      Study Procedures:

      Participants will come into the laboratory, provide informed consent, be randomized to one of
      three groups (natural response, breathing meditation, or positive affect induction) and will
      complete forms and questionnaires on demographics, sleep quality, positive and negative
      affect, present-moment affect, pain catastrophizing, mood states (e.g., anger and fatigue),
      present-moment anxiety, and self-efficacy of pain management. Participants will then receive
      instructions and practice for their randomized group assignment (e.g., on how to use the
      positive affect induction). Participants will then complete a cold pressor task (CPT) while
      using the strategy they were instructed to use (i.e., naturally responding, using breathing
      meditation, or using the positive affect induction). Importantly, participants will be
      instructed to begin with their strategy 5 minutes prior to beginning the CPT, to ensure the
      strategy may have an effect during the CPT, which has a maximum duration of 5 minutes.
      Participants will then complete a final brief questionnaire rating their pain intensity, pain
      unpleasantness, present moment affect, self-efficacy of pain management, and feasibility and
      acceptability of the strategy used.

      The CPT is an acute pain task wherein participants put their hand in a cold-water bath. Ice
      packs will be used within the water bucket to maintain a temperature no greater than 41.0
      degrees Fahrenheit (5 degrees Celsius), and participants will have their hand in the water
      for no greater than five minutes (a maximum time limit of five minutes will be set to prevent
      any adverse, hypothermic effects from the cold water). The participant will provide both
      subjective (self-report pain intensity and unpleasantness) and objective (observation
      of/timed contact with water) measures from the acute pain task. Self-report measures will be
      taken directly following the CPT. Pain tolerance will be measured via timing when
      participants remove their hand from the water. The participants will be timed for how long
      they keep their hand in the water (observation of contact).

      Data Collection & Management:

      Electronic case report forms and study data management will be performed using the REDCap
      Study Data Management System through the Colorado Clinical and Translational Sciences
      Institute (CCTSI) Informatics Core. REDCap is a HIPAA-compliant research data management
      system developed at Vanderbilt University and deployed at over 1500 institutions. At CU
      Denver-Anschutz, REDCap is supported by the Office of Information Technology's Development
      and Informatics Service Center (DISC) and the CCTSI Informatics Core. The CU Denver REDCap
      installation has passed a rigorous 6-week security threat analysis performed by the CU
      Denver-Anschutz HIPAA Security Officer. All study data are stored on a secure database server
      which is separate from the web-facing server -- a best-practices for internet-based security.
      All user access requires unique user accounts and passwords. All user actions are recorded in
      a secure audit log. The database server is routinely backed-up. All security patches and
      application updates are applied immediately upon release by DISC.

      Unanticipated Problems/Adverse Events Reporting:

      Unanticipated problems and adverse events will be reported to the Colorado Multiple
      Institutional Review Board within 5 days of an event.

      Statistical Analysis Plan:

      Data quality checks will be performed to ensure data included in analyses are interpretable,
      consistent, and within range.

      Manipulation Checks:

      To assess whether the affect induction and breathing meditation increase positive affect,
      paired t-tests will be conducted on present-moment affect measures from baseline and post-CPT
      questionnaires.

      Aim 1 To assess feasibility, a one-way ANOVA will be run between groups as a manipulation
      check for MPAI efficacy. Means, standard deviations, and percentages will additionally be
      calculated for feasibility and acceptability items. Good feasibility and acceptability will
      be considered by an a priori threshold of high participant mean ratings (≥80%) for each item.

      Aim 2 To assess efficacy of the MPAI on pain from the CPT, one-way ANCOVAs will be calculated
      to analyze omnibus between-group effects for each pain measure (i.e., for CPT pain tolerance,
      intensity, and unpleasantness). Post-hoc comparisons will then be calculated to determine
      specific group differences (e.g., PA vs BM, PA vs NR, and BM vs NR). Correlation analyses
      will be run on all covariates, to assess for multicollinearity prior to inclusion in ANCOVA
      analyses. Covariates to be analyzed include: Patient Reported Outcomes Measurement
      Information System (PROMIS) sleep disturbance (past seven days), PANAS (positive and negative
      affect past seven days), baseline present-moment affect, pain catastrophizing, present-moment
      anxiety, baseline PBQ (self-efficacy of pain management), gender, and meditation experience.

      Aim 3 To assess for change in self-efficacy in pain management, a paired t-test will be
      calculated between baseline and post-CPT PBQ scores. A linear mixed model will additionally
      be calculated to assess change differences between groups; however, as the primary goal of
      Aim 3 is not to assess between group changes in pain management self-efficacy, this will be
      an exploratory analysis.

      Study Hypotheses:

      Aim1. Hypothesis 1. It is hypothesized that the mindfulness-enhanced positive affect
      induction will have good feasibility and acceptability for improving the experience of
      experimentally induced pain, based on an a priori threshold of ≥80% mean ratings on related
      measures.

      Aim 2. Hypothesis 1. Compared to the BM and NR groups, the MPAI will result in significantly
      greater pain tolerance, less pain intensity, and less pain unpleasantness in relation to the
      experimentally induced pain.

      Aim 3. Hypothesis 1. Self-efficacy in pain management will significantly increase from
      baseline to post-CPT, for the MPAI and BM groups.

      Hypothesis 2. A repeated measures ANOVA will show increased PBQ scores for the MPAI and BM
      groups; however, no changes in PBQ
    

Intervention name(s): Mindfulness-enhanced positive affect induction; Breathing Meditation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive brief psychoeducation about biopsychosocial pain management and practice with the MPAI via guided audio recording. They will then listen to the audio recording a final time before beginning the cold pressor test for experimental pain induction. They will be instructed to continue using the MPAI to manage pain during the cold pressor test.; Participants will receive brief psychoeducation about biopsychosocial pain management and practice with the BM via guided audio recording. They will then listen to the audio recording a final time before beginning the cold pressor test for experimental pain induction. They will be instructed to continue using the BM to manage pain during the cold pressor test.
Other intervention name(s): MPAI; BM
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Participants will be randomized to one of three groups: mindfulness-enhanced positive affect induction (MPAI), breathing meditation (BM), or natural response (NR). Pain will be induced via a cold pressor test (CPT), as the CPT can closely resemble tonic increasing pain similar to that of pain flares. Participants will be instructed to either respond naturally, use the MPAI, or breathing meditation for managing pain during the CPT. Relevant pain related outcomes and covariates will be assessed via baseline and post-CPT questionnaires. The MPAI is the primary intervention being examined, with the BM and NR groups as active comparison and control groups respectively.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Mindfulness-enhanced; Positive affect; Meditation; Pain self-management; Behavioral; Mindfulness; Mindfulness-enhanced positive affect induction (MPAI); Experimentally induced pain; Cold pressor test (CPT); Breathing Meditation (BM); Natural Response (NR)