A Pragmatic Trial to Evaluate the Impact of an Inpatient Psychosocial Transitional Group to Improve Mental Health Outcomes Following Limb Loss

The investigators will conduct a pragmatic trial with a weekly supportive-expressive group therapy (SEGT) intervention for inpatients with limb loss, at a free-standing rehabilitation hospital in Toronto, Canada. This is pragmatic research trial that has stemmed from our feasibility trial involving therapy SEGT for dysvascular lower extremity amputation (LEA) inpatients. Pragmatic trials stand in contrast to randomized controlled trials (RCT's), which instead examine causal relationships and are characterized by rigorous designs, featuring randomization, blinding and allocation concealment, to eliminate bias. Despite yielding results with high internal validity and statistical credibility, RCT's are not always generalizable to real life practice. Perhaps to address this, pragmatic trials are growing in popularity. Pragmatic trials aim to test interventions in routine clinical settings "to maximize applicability and generalizability" as well as to determine whether an intervention works under "real life" conditions. As a complement to our previous feasibility trial, the goal of this work is to understand the effectiveness of SEGT upon mental health outcomes among individuals with limb loss. Hence, the objective is to evaluate the effectiveness of a pragmatic trial using a SEGT intervention for addressing anxiety and depression for inpatients with limb loss.

This two-arm pragmatic trial will evaluate if SEGT leads to better mental health outcomes (depression and anxiety) for inpatients with limb loss compared to those patients who receive treatment as usual (TAU).

Over a 2 year period, 130 inpatients will be recruited for this trial, with 65 being assigned to the SEGT arm and 65 to a TAU condition who receive standard care only (which may include an individual psychiatric consultation).

The proposed 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.

SEGT will be delivered and co-facilitated by either a psychiatrist and/or two allied healthcare professionals supervised by a psychiatrist on a rolling basis for a duration of 1 year or until the intended sample size is achieved. Typically, it is a 6-module program held over a 3-week period (approximately 1 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. Enablement serves to equip the individual with the personal resources to cultivate their self-efficacy and mastery and to select and construct environments that promote successful adaption. For the purposes of this trial, SEGT sessions will be offered on a rolling basis - which means it will be offered once a week, and participants may join the sessions at any time as the sessions will follow a similar framework over a six-modules.