Pain Disengagement Training (Open Pilot)
ConditionChronic Musculoskeletal Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Pain Disengagement Training
BehavioralThe 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Pain Disengagement TrainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of recruitment
\>70% participants approached agree to participate in the intervention
Time frame
Baseline, post-test (6 weeks)2
Acceptability of treatment
\>70% of participants attend at least 6 out of 8 sessions
Time frame
Baseline, post-test (6 weeks)3
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
Baseline4
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)Secondary outcomes
1
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)2
Graded Chronic Pain Scale
Measure of pain severity. 3-item scale rated from 0 to 10 with greater scores indicating greater pain severity and interference
Time frame
Baseline, post-test (6 weeks)3
PROMIS Pain Interference scale
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.
Time frame
Baseline, post-test (6 weeks)4
Brief Pain Inventory
Assesses pain intensity (4 items) on a 0 to 10 scale with greater scores indicating worse pain intensity and interference.
Time frame
Baseline, post-test (6 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov