Pain Disengagement Training (Open Pilot)

Massachusetts General Hospital10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Musculoskeletal Pain

Interventions

Pain Disengagement TrainingBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Outpatient adults (i.e., greater than or equal to 18) 2. Has self reported chronic musculoskeletal pain (i.e., pain persisting for at least 3 months) 3. Pain score greater than or equal to 4 (moderate) on the Numerical Rating Scale 4. Pain catastrophizing score greater than or equal to 20 on Pain Catastrophizing Scale 5. Willingness to engage in a writing-based intervention and self-reported ability to write or type for at least 30 minutes in a sitting 6. Received care at Massachusetts General Hospital 7. English verbal and writing fluency Exclusion Criteria: 1. Clinically significant change in therapy or medication in the past 3 months 2. Severe untreated mental health condition (e.g., psychosis) 3. Active suicidality with history of plan or current intent 4. Serious illness expected to worsen in the next 6 months (e.g., cancer) 5. Untreated substance use problem that, per patient's self-report, would interfere with the ability to complete the intervention.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Feasibility of recruitment

\>70% participants approached agree to participate in the intervention

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

Acceptability of treatment

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

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

Credibility and Expectancy Questionnaire

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.

Time frame: Baseline

Client Satisfaction Questionnaire

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

Time frame: Post-test (6 weeks)

Adherence to intervention

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

Time frame: Mid-intervention

Feasibility of assessments

\>70% of participants have no measures fully missing

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

Secondary Outcomes

Numerical Rating Scale

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

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

Central Contacts

Katherine McDermott, PhD

CONTACT

(617) 643-4208 kmcdermott@mgh.harvard.edu

Ana-Maria Vranceanu, PhD

CONTACT

avranceanu@mgh.harvard.edu

Data from ClinicalTrials.gov

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