Clinical trial NCT03458013: Psychosocial Outcomes in Hand Therapy
Official title: Exploring Psychosocial Outcomes in Hand Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Injuries
Keywords: Mindfulness
Complementary Medicine
Integrative Health
Hand Therapy
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
name: California Foundation for Occupational Therapy
First posted: 2018-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We are using a 2-cohort, nonrandomized comparative design focused on assessing feasibility and acceptability.
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Change in Baseline Salivary Cortisol Across 4 weeks
timeFrame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary outcomes:
measure: Change in Baseline State Anxiety Across 4 weeks
timeFrame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
measure: Change in Baseline Depression Across 4 weeks
timeFrame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
measure: Change in Baseline Pain Catastrophizing Baseline Across 4 weeks
timeFrame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Other outcomes:
Locations:
city: Brea
country: United States
facility: St. Jude Centers for Rehabilitation & Wellness
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Shawn C Roll, PhD
role: STUDY_CHAIR
affiliation: University of Southern California
name: Mark E Hardison, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Sullivan MJ, Bishop SR, Pivik J. The pain catastrophizing scale: Development and validation. Psychological Assessment 7(4): 524 - 532, 1995.