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

Sunnybrook Health Sciences Centre

Status: Completed

Conditions: Amputation

Treatments: Behavioral: Supportive-expressive group therapy (SEGT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05082870

1517

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

25 participants in 2 patient groups

Supportive-expressive group therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Supportive-expressive group therapy (SEGT)

Treatment as usual

No Intervention group

Description:

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