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

NCT05082870 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-07-07

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 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

Interventions

BEHAVIORAL

Supportive-expressive group therapy (SEGT)

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.

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Rosalie Steinberg, MSC, MD · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-19
Primary Completion
2022-12-21
Completion
2022-12-21

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 NCT05082870 on ClinicalTrials.gov