Using a Psychosocial Transitional Group to Improve Adaptation, Coping and Mental Health Outcomes Following Limb Loss

NCT05082870 | Completed

• 1 other identifier: 1517
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Keywords

Group Intervention; Limb Loss; Feasibility

Outcome Measures

Primary Outcomes (6)

• Participant recruitment

  Number of participants who are recruited into the study and are contacted for assessments at set time intervals.

  Through study completion, an average of 1 year.

• Questionnaire completion rates

  Number of completed assessments.

  At 3 months post-discharge for SEGT and control group.

• Treatment adherence

  Number of participants who complete all 6 SEGT sessions.

  Through study completion, an average of 1 year.

• Number of participants contacted for follow up interview

  Number of participants contacted for follow up interview

  At 1 month-post discharge for SEGT group

• Participant retention

  Number of participants who complete the 3 month post-discharge assessments

  At three months post-discharge for SEGT and control group

• Participant retention

  Number of participants who complete 1 month post-discharge interview

  At one month post-discharge for SEGT group

Secondary Outcomes (6)

• Change in Depression and Anxiety

  A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge

• Change in Self-efficacy

  A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge

• Change in Body image

  A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge

• Change in Health-related quality of life

  A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge

• Change in Community participation

  A. 3 months post-discharge

Study Arms (2)

Supportive-expressive group therapy

EXPERIMENTAL

The SEGT approach fosters mutual support, promotes openness and emotional expression. SEGT will be delivered and co-facilitated by a psychiatrist and an allied healthcare professional. It is a 6-module program held over a 3-week period (approximately 2 hour sessions X 2 week) that is framed within social cognitive theory, whereby resilience to adversity (limb loss in this instance) relies on personal enablement.

Behavioral: Supportive-expressive group therapy (SEGT)

Treatment as usual

NO INTERVENTION

The treatment as usual group will receive standard care only (which may include an individual psychiatric consultation).

Interventions

Supportive-expressive group therapy (SEGT) BEHAVIORAL

The SEGT approach fosters mutual support, promotes openness and emotional expression. SEGT will be delivered and co-facilitated by a psychiatrist and an allied healthcare professional. It is a 6-module program held over a 3-week period (approximately 2 hour sessions X 2 week) that is framed within social cognitive theory, whereby resilience to adversity (limb loss in this instance) relies on personal enablement.

Supportive-expressive group therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.)
• Clinical staff who work on the inpatient A1 unit at St. John's Rehab (Sunnybrook Health Sciences Centre)
• Casual or contract staff who have worked on the inpatient A1 unit.
• Non-St. John's Rehab Hospital staff

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Research Institute

Toronto, Ontario, M2M 2G1, Canada

Location

Related Publications (14)

• 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.

  PMID: 10724073 BACKGROUND

• 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.

  PMID: 23624575 BACKGROUND

• 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.

  PMID: 25883037 BACKGROUND

• 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.

  PMID: 25917819 BACKGROUND

• 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.

  PMID: 28273040 BACKGROUND

• 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.

  PMID: 21388445 BACKGROUND

• 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.

  PMID: 18295618 BACKGROUND

• 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.

  PMID: 27069411 BACKGROUND

• 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.

  PMID: 24766143 BACKGROUND

• 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.

  PMID: 23279009 BACKGROUND

• 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.

  PMID: 15497913 BACKGROUND

• 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.

  PMID: 21050130 BACKGROUND

• 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.

  PMID: 24526895 BACKGROUND

• 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.

  BACKGROUND

Study Officials

• Rosalie Steinberg, MSC, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Research Coordinator and Statistician analyzing the data will be blinded to group allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 19, 2021
• Study Start: October 19, 2021
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)