Group Psychotherapy for Mental Health after Amputation

Overseen By Oksana Kachmarchuk, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Active psychosis, Unmanaged psychiatric disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 3 weeks

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Rosalie Steinberg, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who are inpatients at St. John's Rehab with any type and level of limb loss, medically stable, without active psychosis or major unmanaged psychiatric disorders, and no cognitive impairment concerns. They must be able to participate effectively in group therapy.

Inclusion Criteria

I have lost a limb, regardless of the cause or level of amputation.

No clinical suspicion of cognitive impairment

No history of active psychosis or unmanaged major psychiatric disorder

Exclusion Criteria

Unable to participate effectively in a group setting (e.g. actively using substances, exhibiting threatening behaviors)

Actively suicidal

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline Assessment

Participants undergo baseline assessments including socio-demographics, impairment, and mental health history

1-2 weeks

1 visit (in-person or virtual)

Treatment

Participants receive weekly supportive-expressive group therapy (SEGT) sessions for 3 weeks

3 weeks

3 visits (in-person or virtual)

Discharge Assessment

Participants are assessed 48-72 hours after the intervention ends to evaluate changes in mental health outcomes

1 week

1 visit (in-person or virtual)

Follow-up

Participants are monitored for mental health outcomes 3 months post-discharge

3 months

1 visit (phone or Zoom)

What Are the Treatments Tested in This Trial?

Interventions

• Supportive-expressive group therapy
• Treatment as usual

Trial Overview The trial tests a new psychosocial group therapy program against the usual treatment for limb loss patients. It aims to improve mental health during rehabilitation by having them share experiences and coping strategies under the guidance of psychiatrists and occupational therapists.

How Is the Trial Designed?

Group I: Supportive-expressive group therapy Experimental Treatment 1 Intervention

An intervention is based on the evidence-based supportive-expressive approach that was designed by an interprofessional team from psychiatry, social work, physiatry and occupational therapy, along with patient advisors. This SEGT approach has been modified, in both content and process, to specifically address the needs of limb loss inpatients.

Group II: Treatment as usual Active Control 1 Intervention

Standard care for impatiens with limb loss at St. John's Rehab - Sunnybrook Health Sciences Centre. 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.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+