Chronic Musculoskeletal PainNCT06870162
Pain Disengagement Training (Open Pilot)
A study testing Pain Disengagement Training in people with Chronic Musculoskeletal Pain, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Musculoskeletal Pain
- What is being tested?
- Pain Disengagement Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2025to 10 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ana-Maria Vranceanu, PhD contact
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Katherine McDermott, PhD, (617) 643-4208, kmcdermott@mgh.harvard.edu
Katherine McDermott, PhD
About this study
Official title: Pain Disengagement Training: A Self-directed Intervention for Pain Catastrophizing (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.
Read the detailed description
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.
- Conditions
- Chronic Musculoskeletal Pain
- Being tested
- Pain Disengagement Training
- Keywords
- pain catastrophizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Disengagement TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pain Disengagement Training | Experimental | 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. Receives: Behavioral: Pain Disengagement Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
>70% participants approached agree to participate in the intervention
Measured: Baseline, post-test (6 weeks)
Acceptability of treatment
>70% of participants attend at least 6 out of 8 sessions
Measured: 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.
Measured: 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.
Measured: Post-test (6 weeks)
Adherence to intervention
Percent of writing sections demonstrate correct themes (e.g., anxiety words in imaginal exposure writing)
Measured: Mid-intervention
Feasibility of assessments
>70% of participants have no measures fully missing
Measured: Baseline, post-test (6 weeks)
Secondary outcomes (15)
Numerical Rating Scale
Rating of pain intensity on a 0-10 1-item scale with greater scores indicating greater pain intensity
Measured: Baseline, post-test (6 weeks)
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
Measured: Baseline, post-test (6 weeks)
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.
Measured: Baseline, post-test (6 weeks)
Brief Pain Inventory
Assesses pain intensity (4 items) on a 0 to 10 scale with greater scores indicating worse pain intensity and interference.
Measured: Baseline, post-test (6 weeks)
Patient Health Questionnaire - 9
Measure of depressive symptoms. 9-item scale rated from 0 to 3 with greater scores indicating greater depressive symptoms.
Measured: Baseline, post-test (6 weeks)
PROMIS depression scale-8
Measure of depressive symptoms. 8-item scale rated from 1 to 5 with greater scores indicating greater depressive symptoms.
Measured: Baseline, post-test (6 weeks)
Penn State Worry Questionnaire - abbreviated
8-item measure of worry rated from 1 to 5 with greater scores indicating greater worry.
Measured: Baseline, post-test (6 weeks)
Pain Catastrophizing Scale
Assesses magnification, helplessness, and rumination in response to pain. 13-item scale rated 0 to 4 with greater scores indicating greater pain catastrophizing.
Measured: Baseline, post-test (6 weeks)
Pain Anxiety Symptom Scale - Short Form (PASS-20)
Assesses fear and anxiety in response to pain. 20-item scale rated 0 to 5 with greater scores indicating greater pain anxiety.
Measured: Baseline, post-test (6 weeks)
Worry Disengagement Questionnaire
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.
Measured: Baseline, post-test (6 weeks)
Behavioral Activation for Depression Scale - Short Form
Assesses engagement in meaningful activities. 9-item measure rated from 0 to 6 with greater scores indicating greater activity engagement.
Measured: Baseline, post-test (6 weeks)
Positive emotion rating scale
Assesses level of emotional intensity on a 4-item scale from 1 to 5 with greater scores indicating more positive emotionality.
Measured: Mid-intervention
Contrast Avoidance Questionnaire-General Emotion and Worry subscales
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.
Measured: Baseline, post-test (6 weeks)
PROMIS meaning and purpose scale short form 4a
4 item scale assessing meaning and fulfillment in life (1 to 5 rating scale)
Measured: Baseline, post-test (6-weeks)
Self-Compassion Scale
12 item 1 to 5 scale measuring self-compassion
Measured: Baseline, Post-test (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start14 Oct 2025
- Primary completion10 Dec 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Katherine A McDermott, Massachusetts General Hospital
- Investigators
- Katherine McDermott, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870162
- Sponsor's protocol ID
- 2025p000348
- Other IDs
- 1K23AT012789-01
- Status last verified
- Aug 2026
- First submitted
- 5 Mar 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will include feasibility assessments, intervention measures (i.e., peak emotion during writing periods) and pre and post intervention self-report questionnaires in the open pilot.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Disengagement Training: A Self-directed Intervention for Pain Catastrophizing (Open Pilot)
- ClinicalTrials.gov ID
- NCT06870162
- Acronym / sponsor ID
- 2025p000348
- Conditions
- Chronic Musculoskeletal Pain
- Keywords
- pain catastrophizing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain Disengagement Training | Experimental | Behavioral: Pain Disengagement TrainingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Disengagement TrainingThe 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. | Behavioural | Pain Disengagement Training |
Primary outcome
Feasibility of recruitment
Time frame: Baseline, post-test (6 weeks)
>70% participants approached agree to participate in the intervention
Acceptability of treatment
Time frame: Baseline, post-test (6 weeks)
>70% of participants attend at least 6 out of 8 sessions
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.
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.
Adherence to intervention
Time frame: Mid-intervention
Percent of writing sections demonstrate correct themes (e.g., anxiety words in imaginal exposure writing)
Feasibility of assessments
Time frame: Baseline, post-test (6 weeks)
>70% of participants have no measures fully missing
15 secondary outcomes
Numerical Rating Scale
Time frame: Baseline, post-test (6 weeks)
Graded Chronic Pain Scale
Time frame: Baseline, post-test (6 weeks)
PROMIS Pain Interference scale
Time frame: Baseline, post-test (6 weeks)
Brief Pain Inventory
Time frame: Baseline, post-test (6 weeks)
Patient Health Questionnaire - 9
Time frame: Baseline, post-test (6 weeks)
PROMIS depression scale-8
Time frame: Baseline, post-test (6 weeks)
Penn State Worry Questionnaire - abbreviated
Time frame: Baseline, post-test (6 weeks)
Pain Catastrophizing Scale
Time frame: Baseline, post-test (6 weeks)
Pain Anxiety Symptom Scale - Short Form (PASS-20)
Time frame: Baseline, post-test (6 weeks)
Worry Disengagement Questionnaire
Time frame: Baseline, post-test (6 weeks)
Behavioral Activation for Depression Scale - Short Form
Time frame: Baseline, post-test (6 weeks)
Positive emotion rating scale
Time frame: Mid-intervention
Contrast Avoidance Questionnaire-General Emotion and Worry subscales
Time frame: Baseline, post-test (6 weeks)
PROMIS meaning and purpose scale short form 4a
Time frame: Baseline, post-test (6-weeks)
Self-Compassion Scale
Time frame: Baseline, Post-test (6 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified data will include feasibility assessments, intervention measures (i.e., peak emotion during writing periods) and pre and post intervention self-report questionnaires in the open pilot.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ana-Maria Vranceanu, PhD contact
Katherine McDermott, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Disengagement Training in people with Chronic Musculoskeletal Pain, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine McDermott, PhD ((617) 643-4208, kmcdermott@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: Baseline, post-test (6 weeks)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.