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NCT Number: NCT06870162

Pain Disengagement Training (Open Pilot)

The investigators aim to conduct an open pilot trial to determine the initial feasibility of a self-directed writing-based intervention in individuals with chronic musculoskeletal pain and elevated pain catastrophizing. The investigators will assess the feasibility of recruitment, acceptability of the treatment, credibility and participant satisfaction, treatment adherence, and feasibility of assessments following pre-specified benchmarks.

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Key information

Conditions

Chronic Musculoskeletal Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Katherine McDermott, PhD

CONTACT

[email protected]

(617) 643-4208

Katherine McDermott, PhD

PRINCIPAL_INVESTIGATOR

About this study

Mind-body interventions are some of the most effective treatments for chronic pain, yet due to lack of resources, many are inaccessible to the patients who need them. The investigators seek to fill this gap by developing and testing Pain Disengagement Training (PDT) for the treatment of chronic pain catastrophizing, a key risk factor for pain interference. The investigators will administer the PDT treatment in a small number (approximately 10) of participants to evaluate initial benchmarks (the feasibility of recruitment, acceptability of the treatment, credibility and participant satisfaction, treatment adherence, and feasibility of assessments) and to assess participants' experience with the intervention using qualitative exit interviews. Results will inform the refinement of the intervention for a future larger trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatient adults (i.e., greater than or equal to 18)
  • Has self reported chronic musculoskeletal pain (i.e., pain persisting for at least 3 months)
  • Pain score greater than or equal to 4 (moderate) on the Numerical Rating Scale
  • Pain catastrophizing score greater than or equal to 20 on Pain Catastrophizing Scale
  • Willingness to engage in a writing-based intervention and self-reported ability to write or type for at least 30 minutes in a sitting
  • Received care at Massachusetts General Hospital
  • English verbal and writing fluency

Exclusion criteria

  • Clinically significant change in therapy or medication in the past 3 months
  • Severe untreated mental health condition (e.g., psychosis)
  • Active suicidality with history of plan or current intent
  • Serious illness expected to worsen in the next 6 months (e.g., cancer)
  • Untreated substance use problem that, per patient's self-report, would interfere with the ability to complete the intervention.

Treatment and study plan

Pain Disengagement Training

Behavioral

The intervention involves approximately 8 sessions. The first session will involve a psychoeducation component describing the association between negative emotions and pain and the rationale for the intervention strategies. The intervention sessions will consist of approximately 30 minutes of writing alternating between imaginal exposure writing and positive writing periods alternating back and forth (e.g., 3-5 minutes of imaginal exposure writing followed by 3-5 minutes of positive writing before returning to imaginal exposure writing, etc.). Exposure writing will involve writing about a pain-related catastrophic worry repeatedly until it becomes less anxiety-provoking. The positive writing topics will change with each prompt and will be structured by session theme (e.g., values/goals, meaningful activities). They will also complete between session practice by setting aside a time for worrying and then completing a meaningful activity.

Primary outcomes

  1. Feasibility of recruitment

    Time frame: Baseline, post-test (6 weeks)

    >70% participants approached agree to participate in the intervention

  2. Acceptability of treatment

    Time frame: Baseline, post-test (6 weeks)

    >70% of participants attend at least 6 out of 8 sessions

  3. Credibility and Expectancy Questionnaire

    Time frame: Baseline

    Measures perception that the treatment is credible and will offer improvements. Credibility (4 items) is rated from 1-9 with higher scores indicating more credibility. Expectancy is rated from 0-10 with higher scores indicating greater expectancy of improvement.

  4. Client Satisfaction Questionnaire

    Time frame: Post-test (6 weeks)

    Measure of client satisfaction with a program or intervention. 8-item scale measured from 1 to 4 with greater scores indicating greater satisfaction.

  5. Adherence to intervention

    Time frame: Mid-intervention

    Percent of writing sections demonstrate correct themes (e.g., anxiety words in imaginal exposure writing)

  6. Feasibility of assessments

    Time frame: Baseline, post-test (6 weeks)

    >70% of participants have no measures fully missing

Secondary outcomes

  1. Numerical Rating Scale

    Time frame: Baseline, post-test (6 weeks)

    Rating of pain intensity on a 0-10 1-item scale with greater scores indicating greater pain intensity

  2. Graded Chronic Pain Scale

    Time frame: Baseline, post-test (6 weeks)

    Measure of pain severity. 3-item scale rated from 0 to 10 with greater scores indicating greater pain severity and interference

  3. PROMIS Pain Interference scale

    Time frame: Baseline, post-test (6 weeks)

    Assesses pain interference in the past 7 days in activities, work, chores, etc. 8-item scale (1 - not at all to 5 - very much) with greater scores indicating greater pain interference.

  4. Brief Pain Inventory

    Time frame: Baseline, post-test (6 weeks)

    Assesses pain intensity (4 items) on a 0 to 10 scale with greater scores indicating worse pain intensity and interference.

  5. Patient Health Questionnaire - 9

    Time frame: Baseline, post-test (6 weeks)

    Measure of depressive symptoms. 9-item scale rated from 0 to 3 with greater scores indicating greater depressive symptoms.

  6. PROMIS depression scale-8

    Time frame: Baseline, post-test (6 weeks)

    Measure of depressive symptoms. 8-item scale rated from 1 to 5 with greater scores indicating greater depressive symptoms.

  7. Penn State Worry Questionnaire - abbreviated

    Time frame: Baseline, post-test (6 weeks)

    8-item measure of worry rated from 1 to 5 with greater scores indicating greater worry.

  8. Pain Catastrophizing Scale

    Time frame: Baseline, post-test (6 weeks)

    Assesses magnification, helplessness, and rumination in response to pain. 13-item scale rated 0 to 4 with greater scores indicating greater pain catastrophizing.

  9. Pain Anxiety Symptom Scale - Short Form (PASS-20)

    Time frame: Baseline, post-test (6 weeks)

    Assesses fear and anxiety in response to pain. 20-item scale rated 0 to 5 with greater scores indicating greater pain anxiety.

  10. Worry Disengagement Questionnaire

    Time frame: Baseline, post-test (6 weeks)

    Measures ability to shift attention from worry. 4-item scale rated from 0 to 10 with greater scores indicating greater ability to shift attention away from worry.

  11. Behavioral Activation for Depression Scale - Short Form

    Time frame: Baseline, post-test (6 weeks)

    Assesses engagement in meaningful activities. 9-item measure rated from 0 to 6 with greater scores indicating greater activity engagement.

  12. Positive emotion rating scale

    Time frame: Mid-intervention

    Assesses level of emotional intensity on a 4-item scale from 1 to 5 with greater scores indicating more positive emotionality.

  13. Contrast Avoidance Questionnaire-General Emotion and Worry subscales

    Time frame: Baseline, post-test (6 weeks)

    Measures ability to sustain negative emotionality to protect against sudden shifts in emotion. 25-item scale rated from 1 to 5 with greater scores indicating greater avoidance of contrasting emotional states.

  14. PROMIS meaning and purpose scale short form 4a

    Time frame: Baseline, post-test (6-weeks)

    4 item scale assessing meaning and fulfillment in life (1 to 5 rating scale)

  15. Self-Compassion Scale

    Time frame: Baseline, Post-test (6 weeks)

    12 item 1 to 5 scale measuring self-compassion

Study contacts

Contact information is provided by the study sponsor or research team.

Ana-Maria Vranceanu, PhD

CONTACT

[email protected]

Katherine McDermott, PhD

CONTACT

[email protected]

(617) 643-4208

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Pain Disengagement Training: A Self-directed Intervention for Pain Catastrophizing (Open Pilot)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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