Psychosocial Outcomes in Hand Therapy

NCT03458013 | Completed

• 1 other identifier: HS-17-00935
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Hand Injuries

Keywords

Mindfulness; Complementary Medicine; Integrative Health; Hand Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change in Baseline State Anxiety Across 4 weeks

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

• Change in Baseline Depression Across 4 weeks

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

• Change in Baseline Pain Catastrophizing Baseline Across 4 weeks

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

Study Arms (2)

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.

Behavioral: Mindfulness Meditation

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.

Interventions

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.

Mindfulness Meditation plus Hand Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead
• Abbott Medical Devices: collaborator
• California Foundation for Occupational Therapy: collaborator

Study Sites (2)

St. Jude Centers for Rehabilitation & Wellness

Brea, California, 92821, United States

Location

University of Southern California

Los Angeles, California, 90089, United States

Location

Related Publications (4)

• 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.

  PMID: 8845424 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.

  BACKGROUND

MeSH Terms

Conditions

Hand Injuries

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Shawn C Roll, PhD

  University of Southern California

  STUDY CHAIR

• Mark E Hardison, MS

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: We are using a 2-cohort, nonrandomized comparative design focused on assessing feasibility and acceptability.

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: March 8, 2018
• Study Start: May 1, 2018
• Primary Completion: January 22, 2020
• Study Completion: January 22, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)