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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
| California Foundation for Occupational Therapy | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Meditation plus Hand Therapy | Experimental | 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. |
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| Standard Care in Hand Therapy | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Meditation | Behavioral | Guided using an mp3 player and noise cancelling headphones, participants will be led through a series of mindfulness meditations lasting approximately 20 minutes each. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Baseline Salivary Cortisol Across 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. | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Baseline State Anxiety Across 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. | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shawn C Roll, PhD | University of Southern California | Study Chair |
| Mark E Hardison, MS | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Centers for Rehabilitation & Wellness | Brea | California | 92821 | United States | ||
| University of Southern California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8845424 | Background | Aardal E, Holm AC. Cortisol in saliva--reference ranges and relation to cortisol in serum. Eur J Clin Chem Clin Biochem. 1995 Dec;33(12):927-32. doi: 10.1515/cclm.1995.33.12.927. | |
| Background | 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. | ||
| Background | 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. | ||
| Background | Sullivan MJ, Bishop SR, Pivik J. The pain catastrophizing scale: Development and validation. Psychological Assessment 7(4): 524 - 532, 1995. |
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| ID | Term |
|---|---|
| D006230 | Hand Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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We are using a 2-cohort, nonrandomized comparative design focused on assessing feasibility and acceptability.
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| Change in Baseline Depression Across 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. | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks |
| Change in Baseline Pain Catastrophizing Baseline Across 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. | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks |
| Los Angeles |
| California |
| 90089 |
| United States |