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Completed

NCT Number: NCT03212105

A 60-seconds Personalized Mindfulness Video Exercise for Patients With Orthopedic Illness

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.

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Key information

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

60 Second Video

Behavioral

The mindfulness intervention will be a video-flash found at http://www.pixelthoughts.co. In this exercise patients are asked to write down a concern or worry, and watch it get put into perspective within a 60 seconds time frame.

Educational Brochure

Other

The educational pamphlet will contain information about pain and stress, which patients will be able to read within 60 seconds.

Other names: Placebo comparator

Primary outcomes

  1. Client Satisfaction Scale-3 (CSQ-3)

    Time frame: Day 1 after completing 60-second intervention

    The client satisfaction scale-3 (CSQ-3) is a 3 question instrument to measure satisfaction with health and human services. Responses are based on a 4-point scale. The score range is from 3-12, where higher values indicate higher satisfaction.

Secondary outcomes

  1. Change in State-Trait Anxiety Inventory (STAI)

    Time frame: Before intervention, immediately after intervention, and 3 months after enrollment

    The STAI questionnaire measures trait and state anxiety. The questionnaire has 20 items based on a 4-point scale. A higher score is indicative of greater anxiety.

  2. Change in Pain Intensity

    Time frame: Before intervention, immediately after intervention, and 3 months after enrollment

    Pain intensity as measured by ordinal rating of pain. On a scale from 0-10, where 0 is no pain and 10 is the worst pain imagined.

  3. Change in Distress, Anxiety, Depression, and Anger

    Time frame: Before intervention, immediately after intervention, and 3 months after enrollment

    A visual scale using 4 emotional thermometers to measure each distress, anxiety, depression, and anger. The scale is from 0-10, where 0 means experience none of the emotion and 10 is extreme.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2017
Registry last updated
Aug 17, 2018

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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