Clinical trial NCT05082870: Using a Psychosocial Transitional Group to Improve Adaptation, Coping and Mental Health Outcomes Following Limb Loss
Official title: Using a Psychosocial Transitional Group to Improve Adaptation, Coping and Mental Health Outcomes Following Limb Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Keywords: Group Intervention
Limb Loss
Feasibility
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: People with limb loss receiving inpatient rehabilitation are at greater risk for depression and anxiety, social isolation, and generally have poor quality of life. To proactively address the mental health needs of this population, this study plans to test an innovative psychological group therapy program designed for limb loss inpatients to enhance coping skills, address mental health challenges, and better prepare them to integrate back into the community via a randomized blinded feasibility trial. Since this is a novel intervention, adapted specifically for limb loss, this study will test the feasibility of delivering this inpatient group program to these at-risk individuals to see: if they will participate in the program, what they like/do not like about it, and if there are some early findings suggesting it is effective. Researchers will use these results to improve the psychosocial group program and to further test its effectiveness in a larger clinical study.

Detailed description: Lower limb extremity amputation (LEA) is a debilitating event that negatively affects many aspects of an individual's life, such as their mobility, physical and mental health, and ultimately quality of life (QoL). Due to the high rates of diabetes in Canada, the most common type of limb loss is dysvascular due to complications of diabetes/vascular disease.

Compared to other limb loss populations (trauma or tumor), people with dysvascular LEA have been shown to have poorer QoL. Premorbid comorbidities (e.g. coronary heart disease, etc.), and post-morbid complications such as depression, anxiety and chronic pain further impact wellbeing. Sequelae of these issues include impaired body image, and high rates of suicidal ideation. Rates of depression have been found to be as high as 60%; comorbid depression is associated with lower prosthetic use, higher perceived vulnerability, and lower self-rated overall health. Providers, however, often focus efforts on the patients' physical recovery post-LEA and may not adequately address psychosocial functioning.

There is some preliminary evidence on the efficacy of group therapy approaches for limb loss patients undergoing inpatient rehabilitation in India, and outpatient rehabilitation in Canada, but findings are limited and may not be fully generalizable to dysvascular LEA.

Hence, the planned innovative intervention will provide clarification on the feasibility of undertaking a larger scale trial to assess the efficacy of an inpatient group therapy approach to address the mental health concerns (i.e., depression and anxiety) and psychosocial needs (i.e. coping skills) of limb loss patients. Based on available knowledge, this would be the first of its kind in Canada.

Eligibility criteria: Patient Inclusion Criteria:

* English-speaking adult inpatients (18 years and older)
* Dysvascular-related lower extremity amputation
* Medically stable
* No clinical suspicion of cognitive impairment
* No history of active psychosis or unstable severe mental health diagnosis (no diagnosis of schizophrenia, dementia, etc.)
* Admitted inpatients to St. John's Rehab Hospital (Sunnybrook Health Sciences Centre).

Patient Exclusion Criteria:

* Actively suicidal
* Unable participate effectively in a group setting
* Non-dysvascular lower extremity amputation
* Non-English-speaking
* Children (under the age of 18)
* Medically unstable
* Clinical suspicion of cognitive impairment
* History of active psychosis or unstable severe mental health diagnosis (diagnosis of schizophrenia, dementia, etc.)

Staff Inclusion Criteria: (Note: Staff will not be part of intervention, but will be asked to share their perspectives on the intervention)

* Clinical staff who work on the inpatient A1 unit at St. John's Rehab (Sunnybrook Health Sciences Centre)

Staff Exclusion Criteria:

* Casual or contract staff who have worked on the inpatient A1 unit.
* Non-St. John's Rehab Hospital staff

Primary outcomes:
measure: Participant recruitment
timeFrame: Through study completion, an average of 1 year.
measure: Questionnaire completion rates
timeFrame: At 3 months post-discharge for SEGT and control group.
measure: Treatment adherence
timeFrame: Through study completion, an average of 1 year.
measure: Number of participants contacted for follow up interview
timeFrame: At 1 month-post discharge for SEGT group
measure: Participant retention
timeFrame: At three months post-discharge for SEGT and control group
measure: Participant retention
timeFrame: At one month post-discharge for SEGT group
Secondary outcomes:
measure: Change in Depression and Anxiety
timeFrame: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
measure: Change in Self-efficacy
timeFrame: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
measure: Change in Body image
timeFrame: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
measure: Change in Health-related quality of life
timeFrame: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
measure: Change in Community participation
timeFrame: A. 3 months post-discharge
measure: Psychiatric consultations
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Rosalie Steinberg, MSC, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pezzin LE, Dillingham TR, MacKenzie EJ. Rehabilitation and the long-term outcomes of persons with trauma-related amputations. Arch Phys Med Rehabil. 2000 Mar;81(3):292-300. doi: 10.1016/s0003-9993(00)90074-1.
citation: Fortington LV, Dijkstra PU, Bosmans JC, Post WJ, Geertzen JH. Change in health-related quality of life in the first 18 months after lower limb amputation: a prospective, longitudinal study. J Rehabil Med. 2013 Jun;45(6):587-94. doi: 10.2340/16501977-1146.
citation: Turner AP, Meites TM, Williams RM, Henderson AW, Norvell DC, Hakimi KN, Czerniecki JM. Suicidal ideation among individuals with dysvascular lower extremity amputation. Arch Phys Med Rehabil. 2015 Aug;96(8):1404-10. doi: 10.1016/j.apmr.2015.04.001. Epub 2015 Apr 14.
citation: Amtmann D, Morgan SJ, Kim J, Hafner BJ. Health-related profiles of people with lower limb loss. Arch Phys Med Rehabil. 2015 Aug;96(8):1474-83. doi: 10.1016/j.apmr.2015.03.024. Epub 2015 Apr 25.
citation: Bilandzic A, Rosella L. The cost of diabetes in Canada over 10 years: applying attributable health care costs to a diabetes incidence prediction model. Health Promot Chronic Dis Prev Can. 2017 Feb;37(2):49-53. doi: 10.24095/hpcdp.37.2.03.
citation: Moxey PW, Gogalniceanu P, Hinchliffe RJ, Loftus IM, Jones KJ, Thompson MM, Holt PJ. Lower extremity amputations--a review of global variability in incidence. Diabet Med. 2011 Oct;28(10):1144-53. doi: 10.1111/j.1464-5491.2011.03279.x.
citation: Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.
citation: Padovani MT, Martins MR, Venancio A, Forni JE. Anxiety, depression and quality of life in individuals with phantom limb pain. Acta Ortop Bras. 2015 Mar-Apr;23(2):107-10. doi: 10.1590/1413-78522015230200990.
citation: McDonald S, Sharpe L, Blaszczynski A. The psychosocial impact associated with diabetes-related amputation. Diabet Med. 2014 Nov;31(11):1424-30. doi: 10.1111/dme.12474. Epub 2014 May 24.
citation: Fleury AM, Salih SA, Peel NM. Rehabilitation of the older vascular amputee: a review of the literature. Geriatr Gerontol Int. 2013 Apr;13(2):264-73. doi: 10.1111/ggi.12016. Epub 2012 Dec 26.
citation: Horgan O, MacLachlan M. Psychosocial adjustment to lower-limb amputation: a review. Disabil Rehabil. 2004 Jul 22-Aug 5;26(14-15):837-50. doi: 10.1080/09638280410001708869.
citation: Schaffalitzky E, Gallagher P, Maclachlan M, Ryall N. Understanding the benefits of prosthetic prescription: exploring the experiences of practitioners and lower limb prosthetic users. Disabil Rehabil. 2011;33(15-16):1314-23. doi: 10.3109/09638288.2010.529234. Epub 2010 Nov 4.
citation: Srivastava K, Chaudhury S. Rehabilitation after amputation: psychotherapeutic intervention module in Indian scenario. ScientificWorldJournal. 2014 Jan 12;2014:469385. doi: 10.1155/2014/469385. eCollection 2014.
citation: Delehanty RD, Trachsel L. Effects of short-term group treatment on rehabilitation outcome of adults with amputations. International Journal of Rehabilitation and Health. 1995;1(2):61-73.