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Psychosocial Transitional Group Pragmatic Trial

NCT05798091 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-05-18

No results posted yet for this study

Summary

People with limb loss receiving inpatient rehabilitation are at greater risk for depression and anxiety, social isolation, and generally have poorer quality of life. To proactively address the mental health needs of this population, St. John's Rehab recruited two psychiatrists to provide mental health support to their inpatient population groups. Because there are limits to mental health resources and because group therapy facilitates patients learning from each other, the investigators plan to test an innovative psychological group therapy program designed for limb loss inpatients to address mental health challenges, and to better prepare them to integrate back into the community. Our designed psychosocial group therapy is led by a psychiatrist and an occupational therapist who create a structured process for inpatients to discuss their challenges and identify coping strategies that will help them transition back into the community. The investigators will recruit 130 inpatients with limb loss, with 65 taking part in a weekly psychosocial group therapy program and 65 receiving treatment as usual. The investigators will evaluate if anxiety and depression significantly decreases in our treatment group compared to those who received treatment as usual. The findings of this work will provide needed evidence for the clinical feasibility and utility of a rehabilitation inpatient group therapy program, which can serve as a useful model for other limb loss sites across Canada.

Conditions

  • Amputation
  • Psychotherapy, Group
  • Mental Health

Interventions

BEHAVIORAL

Supportive-expressive group therapy

The intervention is based on the evidence-based supportive-expressive (SEGT) approach and was designed by an interprofessional team from psychiatry, social work, physiatry and occupational therapy, along with patient advisors. The SEGT approach fosters mutual support, promotes openness and emotional expression. It has been shown to yield improvements in anxiety, psychosocial functioning, health literacy, and social support in breast cancer survivors. This SEGT approach has been modified, in both content and process, to specifically address the needs of limb loss inpatients.

OTHER

Treatment as usual

All patients may be referred to social work and/or a psychiatrist to address their mental health needs. As well, members of the interprofessional team provide psycho-social supports where needed. The types of psycho-social supports provided to patients in the TAU condition will be documented (e.g., referral to psychiatrist, social worker, etc.).

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Rosalie Steinberg, MD · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-28
Primary Completion
2025-02-17
Completion
2025-02-17

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05798091 on ClinicalTrials.gov