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Psychosocial Outcomes in Hand Therapy

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ClinicalTrials.gov Identifier: NCT03458013
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : February 1, 2019
Sponsor:
Collaborators:
Abbott Medical Devices
California Foundation for Occupational Therapy
Information provided by (Responsible Party):
Shawn Roll, University of Southern California

Brief Summary:

Rationale: there is a need for psychosocial symptom management in hand therapy which has been understudied. Mindfulness-based interventions are used to address psychosocial symptoms in other settings such as chronic injury but have yet to be implemented or explored for patients in acute outpatient rehabilitation.

Intervention: a supplemental mindfulness-based intervention (MBI) will be provided to the experimental group while the control group will receive standard care. The MBI will begin with an explanation of the purpose of a mindfulness, how mindfulness relates to hand therapy, and lead to a 20-minute guided meditation using an audio recording.

Objectives: to establish the feasibility of providing a MBI in hand therapy and evaluate preliminary effects of the MBI on patients' stress, anxiety, and depression.

Population: adult patients at an outpatient hand therapy clinic in the Los Angeles area who have received a traumatic injury (e.g., tendon laceration, compound fracture, finger amputation).

Methodology: the study will use a mixed-methods, non-randomized, 2-group, comparative trial design with 40 participants in total. Quantitative data on psychosocial outcomes, including salivary cortisol, will be collected once a week for 4 weeks while patients are attending hand therapy and qualitative interviews will be conducted at the end of the study.

Study arms: the experimental group (n = 20) will receive the MBI just before regularly scheduled standard care visits. The control group (n = 20) will receive only standard care.

Outcomes: this pilot study will be used to inform a future fully powered trial on mindfulness-based interventions in hand therapy. Feasibility and preliminary psychosocial effects of MBIs will be evaluated and used to inform future work.

Analysis: (1) A repeated measures ANOVA for intervention group, time, and time by intervention group effects on the psychosocial outcomes (i.e., Cortisol, Anxiety, Depression, and Pain Catastrophizing). (2) A descriptive qualitative process will be used to analyze themes in participant interview responses.


Condition or disease Intervention/treatment Phase
Hand Injuries Behavioral: Mindfulness Meditation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We are using a 2-cohort, nonrandomized comparative design focused on assessing feasibility and acceptability.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Exploring Psychosocial Outcomes in Hand Therapy
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mindfulness Meditation plus Hand Therapy
Participants will be recruited from patients suffering from a traumatic injury who are entering hand therapy at a community based clinic in the Los Angeles area.
Behavioral: Mindfulness Meditation
Guided using an mp3 player and noise cancelling headphones, participants will be led through a series of mindfulness meditations lasting approximately 20 minutes each.

No Intervention: Standard Care in Hand Therapy
Participants will be recruited from patients suffering from a traumatic injury who are entering hand therapy at a community based clinic in the Los Angeles area.



Primary Outcome Measures :
  1. Change in Baseline Salivary Cortisol Across 4 weeks [ Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks ]
    Cortisol is a bio-marker for stress (Aardal & Holm, 1995). Normal values in healthy adults are sensitive to time of day, but range from 3.5 to 27.0 nmol/l in the morning. Higher salivary cortisol levels are an indicator of higher levels of stress.


Secondary Outcome Measures :
  1. Change in Baseline State Anxiety Across 4 weeks [ Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks ]
    The State-Trait Anxiety Inventory: State subscale (Spielberger, Vagg, Barker, Donham, & Westberry, 1980) is scored positively (higher scores equate to higher anxiety) with a minimum score of 20 and a maximum score of 80. Normative data for this scale indicates that a cut point score of 40 and above is considered clinically relevant.

  2. Change in Baseline Depression Across 4 weeks [ Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks ]
    Center for Epidemiologic Studies - Depression scale (CES-D; Radloff, 1977), is a 20-item depression scale that is positively scored (higher scores equate to higher depression) ranging from 0 to 60. It is intended for use with the general population with a conservative off is score being greater than 16.

  3. Change in Baseline Pain Catastrophizing Baseline Across 4 weeks [ Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks ]
    Pain Catastrophizing Scale (Sullivan, Bishop, & Pivik, 1995) measures an individual's exaggerated negative psychological response to pain or the anticipation of pain. The scale is scored positively across 13 total items composing 3 subscales: rumination, magnification, and helplessness. These subscales are added together to get the total score from 0 to 52. The middle 50% of scores on this scale fall between 10 and 30 points.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years old; newly entering hand therapy, having a diagnosis of distal radius fracture, flexor tendon injury and repair, extensor tendon injury and repair, tramatic finger amputation, or other traumatic injury; established therapy plan of care lasting at least 4 weeks; able to read and with in English; with regular access to a computer.

Exclusion Criteria:

  • diagnosed with a severe mental illness; currently an expert in mindfulness practices

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458013


Contacts
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Contact: Mark E Hardison, MS (323) 865-1503 mhardiso@usc.edu

Locations
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United States, California
St. Jude Centers for Rehabilitation & Wellness Recruiting
Brea, California, United States, 92821
Contact: Mary Long, DPT, CHT         
Contact: Marysol Cacciata, RN, MSN         
University of Southern California Not yet recruiting
Los Angeles, California, United States, 90089
Contact: Mark E Hardison, MS, OTR/L       mhardiso@usc.edu   
Contact: Shawn C Roll, PhD, OTR/L         
Sponsors and Collaborators
University of Southern California
Abbott Medical Devices
California Foundation for Occupational Therapy
Investigators
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Study Chair: Shawn C Roll, PhD University of Southern California
Principal Investigator: Mark E Hardison, MS University of Southern California

Publications:
Spielberger CD, Vagg PR, Barker LR, Donham GW, Westberry LG. The factor structure of the State-Trait Anxiety Inventory. In CD Spielberger & IG Sarason (Eds.), Stress and anxiety (pp. 244-279). Washington, DC: Hemisphere; 1980.
Radloff, LS. The CES-D Scale: A self-report depression scale for research in the general population. Applied Psychological Measurement 1(3): 385-401, 1977.
Sullivan MJ, Bishop SR, Pivik J. The pain catastrophizing scale: Development and validation. Psychological Assessment 7(4): 524 - 532, 1995.

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Responsible Party: Shawn Roll, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT03458013     History of Changes
Other Study ID Numbers: HS-17-00935
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shawn Roll, University of Southern California:
Mindfulness
Complementary Medicine
Integrative Health
Hand Therapy

Additional relevant MeSH terms:
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Hand Injuries
Wounds and Injuries