Clinical trial NCT03212105: A 60-seconds Personalized Mindfulness Video Exercise for Patients With Orthopedic Illness
Official title: A 60-seconds Personalized Mindfulness Video Exercise for Patients With Orthopedic Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopaedic Injury
Mindfulness
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine within a randomized controlled trial the feasibility of a 60-second acceptance based mindfulness exercise for patients with musculoskeletal pain versus usual medical care. Feasibility will be evaluated as the number of individuals approached who agree to participate and the number of individuals who drop out prior to completion of post intervention questionnaires.

The investigators aim to determine the usefulness and acceptability of the 60-second acceptance based mindfulness exercise for patients with musculoskeletal pain as compared to usual medical care. Usefulness and acceptability will be assessed with the Client Satisfaction Scale-3 (CSQ-3).

The investigators also aim to determine whether participating in a personalized 60-second acceptance based mindfulness exercise (e.g., intervention) is associated with significantly more improvement in patients' ratings of state anxiety and pain intensity (co-primary outcomes), and to determine if Distress, Anxiety, Depression and Anger (secondary outcomes) decrease compared to a brief educational pamphlet (e.g., control).

The investigators also aim to determine whether any improvements observed will maintain within a 3 month follow up.

Detailed description: A cognitive behavioral therapy practice called Acceptance and Commitment Therapy (ACT) focuses on acceptance rather than control of thoughts, emotions and physical sensations, regardless of their quality. The crux of ACT is teaching patients to separate themselves from their thoughts (e.g., cognitive defusion) and thus decrease the importance placed on them. ACT has been successful in treating psychological disorders and emotional disturbances alone or when associated with physical illnesses, those that cause pain in particular. While ACT is effective, it may not be feasible for busy orthopedic practices. However, simple exercises that teach patients to deemphasize the importance they place on thoughts might be feasible in orthopedic settings where patients present with pain and strong emotions. An ACT exercise, delivered before the orthopedic appointment, has the potential to set the tone for a more positive experience for both patient and provider, by lowering a patient's pain intensity, state anxiety (e.g., anxiety symptoms in the present moment) as measured comprehensively by State-Trait Anxiety Inventory (STAI) questionnaire, distress, depression, anger, and anxiety, all four measured by 1 item emotional thermometers (visual scales used to rate different emotions). This exercise might help patients see ACT exercises as a helpful part of their recovery. Some might be motivated to learn more and to continue using them at home. This could improve their recovery from and adjustment to the medical condition.

Eligibility criteria: Inclusion Criteria:

* All patients presenting to Hand and Upper Extremity Service at Massachusetts General Hospital
* English fluency and literacy

Exclusion Criteria:

* Pregnant women
* Significant Axis I or II psychopathology that would interfere with participation in the study
* Age \< 18 years old

Primary outcomes:
measure: Client Satisfaction Scale-3 (CSQ-3)
timeFrame: Day 1 after completing 60-second intervention
Secondary outcomes:
measure: Change in State-Trait Anxiety Inventory (STAI)
timeFrame: Before intervention, immediately after intervention, and 3 months after enrollment
measure: Change in Pain Intensity
timeFrame: Before intervention, immediately after intervention, and 3 months after enrollment
measure: Change in Distress, Anxiety, Depression, and Anger
timeFrame: Before intervention, immediately after intervention, and 3 months after enrollment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
References: