Psychosocial Factors of Burn Related Injuries and Perceived Gaps in Service Delivery

NCT03094013 | Terminated

• 2 other identifiers: 944614eRS 20227
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study will utilize a mixed methods design featuring quantitative assessment of symptoms in conjunction with collecting in-depth qualitative data. In this study, perceived stress, mental health symptoms and behaviors and other variables will be used to test how they will influence the daily functioning and service utilization for adolescent and adult burn related injury patients at Mercy Hospital St. Louis Burn Center. The data gathered in the interviews will explore these constructs in-depth for the participants.

Conditions

Burns; Psychological

Keywords

psycho-social factors, psychological symptoms

Outcome Measures

Primary Outcomes (29)

• Perceived Stress Scale

  stress levels (adults, adolescents)

  baseline (during hospitalization)

• Burn's Depression Checklist

  depressive symptoms (adults)

  baseline (during hospitalization)

• Burn's Anxiety Inventory

  anxiety symptoms (adults)

  baseline (during hospitalization)

• PTSD Checklist for DSM-5 with Life Events Checklist, Adverse Childhood Experiences Questionnaire, Dissociative Subtype of PTSD Scale

  trauma symptoms (adults)

  baseline (during hospitalization)

• Center for Epidemiological Studies Depression Scale for Children

  depressive symptoms (adolescents)

  baseline (during hospitalization)

• Screen for Child Anxiety Related Disorders

  anxiety symptoms (adolescents)

  baseline (during hospitalization)

• UCLA PTSD Index for DSM (Adolescent version), Adolescent Dissociative Experiences Scale-II

  trauma symptoms (adolescents)

  baseline (during hospitalization)

• Discharge readiness questions

  adults and adolescents

  discharge (approx 2-6 weeks after initial hospitalization)

• Perceived Stress Scale

  stress levels (adults, adolescents)

  approximately 1 month post-hospitalization (after discharge)

• Burn's Depression Checklist

  depressive symptoms (adults)

  approximately 1 month post-hospitalization

• Burn's Anxiety Inventory

  anxiety symptoms (adults)

  approximately 1 month post-hospitalization

• PTSD Checklist for DSM-5 with Life Events Checklist, Adverse Childhood Experiences Questionnaire, Dissociative Subtype of PTSD Scale

  trauma symptoms (adults)

  approximately 1 month post-hospitalization

• Center for Epidemiological Studies Depression Scale for Children

  depressive symptoms (adolescents)

  approximately 1 month post-hospitalization

• Screen for Child Anxiety Related Disorders

  anxiety symptoms (adolescents)

  approximately 1 month post-hospitalization

• UCLA PTSD Index for DSM (Adolescent version), Adolescent Dissociative Experiences Scale-II

  trauma symptoms (adolescents)

  approximately 1 month post-hospitalization

• Perceived Stress Scale

  stress levels (adults, adolescents)

  approximately 6 months post-hospitalization

• Burn's Depression Checklist

  depressive symptoms (adults)

  approximately 6 months post-hospitalization

• Burn's Anxiety Inventory

  anxiety symptoms (adults)

  approximately 6 months post-hospitalization

• PTSD Checklist for DSM-5 with Life Events Checklist, Adverse Childhood Experiences Questionnaire, Dissociative Subtype of PTSD Scale

  trauma symptoms (adults)

  approximately 6 months post-hospitalization

• Center for Epidemiological Studies Depression Scale for Children

  depressive symptoms (adolescents)

  approximately 6 months post-hospitalization

• Screen for Child Anxiety Related Disorders

  anxiety symptoms (adolescents)

  approximately 6 months post-hospitalization

• UCLA PTSD Index for DSM (Adolescent version), Adolescent Dissociative Experiences Scale-II

  trauma symptoms (adolescents)

  approximately 6 months post-hospitalization

• Perceived Stress Scale

  stress levels (adults, adolescents)

  approximately 1 year post- hospitalization

• Burn's Depression Checklist

  depressive symptoms (adults)

  approximately 1 year post- hospitalization

• Burn's Anxiety Inventory

  anxiety symptoms (adults)

  approximately 1 year post- hospitalization

• PTSD Checklist for DSM-5 with Life Events Checklist, Adverse Childhood Experiences Questionnaire, Dissociative Subtype of PTSD Scale

  trauma symptoms (adults)

  approximately 1 year post- hospitalization

• Center for Epidemiological Studies Depression Scale for Children

  depressive symptoms (adolescents)

  approximately 1 year post- hospitalization

• Screen for Child Anxiety Related Disorders

  anxiety symptoms (adolescents)

  approximately 1 year post- hospitalization

• UCLA PTSD Index for DSM (Adolescent version), Adolescent Dissociative Experiences Scale-II

  trauma symptoms (adolescents)

  approximately 1 year post- hospitalization

Secondary Outcomes (24)

• CFPB Financial Well-Being Scale Questionnaire

  baseline (during hospitalization)

• CFPB Financial Well-Being Scale Questionnaire

  approximately 1 month post-hospitalization (after discharge)

• CFPB Financial Well-Being Scale Questionnaire

  approximately 6 months post-hospitalization

• CFPB Financial Well-Being Scale Questionnaire

  approximately 1 year post-hospitalization

• Sleep - Wake Questionnaire

  baseline (during hospitalization)

Interventions

Assessment OTHER

Assessment

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 300 individuals with burn related injuries requiring a skin graft and in the hospital long enough to complete the first assessment, receiving in-patient care at Mercy Hospital Burn Center.

You may qualify if:

• Individuals with burn related injuries requiring a skin graft and in the hospital long enough to complete the first assessment.

You may not qualify if:

• Individuals with burn related injuries, but who do not receive skin grafts.
• Individuals who are physically or mentally unable to give consent for participation.

Sponsors & Collaborators

• St. Louis University: lead
• Mercy Research: collaborator

Study Sites (1)

Mercy Hospital

St Louis, Missouri, 63141, United States

Location

Related Publications (11)

• Attoe C, Pounds-Cornish E. Psychosocial adjustment following burns: An integrative literature review. Burns. 2015 Nov;41(7):1375-84. doi: 10.1016/j.burns.2015.02.020. Epub 2015 Sep 8.

  PMID: 26359733 BACKGROUND

• Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.

  PMID: 3204199 BACKGROUND

• BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.

  PMID: 13688369 BACKGROUND

• Beck, A. T., Steer, R.A., & Garbin, M.G. (1988) Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clinical Psychology Review, 8(1), 77-100.

  BACKGROUND

• Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.

  PMID: 26606250 BACKGROUND

• Bovin MJ, Marx BP, Weathers FW, Gallagher MW, Rodriguez P, Schnurr PP, Keane TM. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in veterans. Psychol Assess. 2016 Nov;28(11):1379-1391. doi: 10.1037/pas0000254. Epub 2015 Dec 14.

  PMID: 26653052 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Esselman PC. Burn rehabilitation: an overview. Arch Phys Med Rehabil. 2007 Dec;88(12 Suppl 2):S3-6. doi: 10.1016/j.apmr.2007.09.020.

  PMID: 18036978 BACKGROUND

• Fauerbach JA, Pruzinsky T, Saxe GN. Psychological health and function after burn injury: setting research priorities. J Burn Care Res. 2007 Jul-Aug;28(4):587-92. doi: 10.1097/BCR.0B013E318093E470. No abstract available.

  PMID: 17514031 BACKGROUND

• Wolf EJ, Mitchell KS, Sadeh N, Hein C, Fuhrman I, Pietrzak RH, Miller MW. The Dissociative Subtype of PTSD Scale: Initial Evaluation in a National Sample of Trauma-Exposed Veterans. Assessment. 2017 Jun;24(4):503-516. doi: 10.1177/1073191115615212. Epub 2015 Nov 23.

  PMID: 26603115 BACKGROUND

• Wortmann JH, Jordan AH, Weathers FW, Resick PA, Dondanville KA, Hall-Clark B, Foa EB, Young-McCaughan S, Yarvis JS, Hembree EA, Mintz J, Peterson AL, Litz BT. Psychometric analysis of the PTSD Checklist-5 (PCL-5) among treatment-seeking military service members. Psychol Assess. 2016 Nov;28(11):1392-1403. doi: 10.1037/pas0000260. Epub 2016 Jan 11.

  PMID: 26751087 BACKGROUND

MeSH Terms

Conditions

Burns

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Noelle Fearn, PhD

  Director-School of Social Work

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: March 29, 2017
• Study Start: May 1, 2017
• Primary Completion: November 2, 2018
• Study Completion: November 2, 2018
• Last Updated: November 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)