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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a group therapy program to help individuals with limb loss improve mental health during rehabilitation. The program aims to reduce anxiety and depression by providing a supportive space for sharing experiences and learning coping strategies. Half of the participants will join supportive-expressive group therapy sessions, while the other half will continue with their usual care. The goal is to determine if the group therapy significantly improves mental health. This trial suits English-speaking inpatients at St. John's Rehab with limb loss, who are medically stable and do not have severe mental health issues like active psychosis. As an unphased trial, it offers patients a unique opportunity to contribute to innovative mental health support strategies in rehabilitation settings.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this group therapy program is safe for inpatients with limb loss?

Research shows that supportive-expressive group therapy (SEGT) is generally safe and well-tolerated for people who have lost a limb. In this therapy, participants join group sessions to share experiences and learn coping strategies. Studies have found that these group settings often improve emotional well-being and social connections. Although specific safety data for SEGT in people with limb loss is limited, group therapies like this are usually considered safe. They focus on mental and emotional support rather than physical treatments, so serious side effects are rare. However, as with any therapy, individual experiences can differ, and discussing concerns with healthcare providers is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about supportive-expressive group therapy for mental health after amputation because it offers a tailored approach that specifically addresses the unique psychological challenges faced by individuals with limb loss. Unlike standard care, which typically involves general psycho-social support and occasional referrals to specialists, this therapy is designed by an interprofessional team to directly target issues related to limb loss. The therapy's focus on fostering emotional expression and support within a group setting aims to enhance coping strategies and emotional well-being, potentially leading to improved mental health outcomes for amputees.

What evidence suggests that this trial's treatments could be effective for mental health after amputation?

Research shows that supportive-expressive group therapy, which participants in this trial may receive, can improve mental health for people who have lost a limb. Studies have found that these group sessions boost emotional well-being and mobility, and they also support learning. Early results suggest that patients in this type of therapy feel less depressed and anxious. The therapy helps patients adjust and cope better after losing a limb. It includes guided discussions led by a psychiatrist and an occupational therapist, where participants share challenges and discover coping strategies. These sessions aim to help patients smoothly reintegrate into their communities. ^{1 2 4 6 7}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12447206/

Characteristics and Outcomes of Limb Loss Support Groups These data highlight structure, development strategies, and positive effects of support groups for mobility, emotional well-being, and learning ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05798091

Psychosocial Transitional Group Pragmatic Trial 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40980537/

Characteristics and Outcomes of Limb Loss Support Groups All studies discussed positive outcomes such as physical ability and mobility improvement on the Prosthetic Limb Users Survey of Mobility, ...

4. jps.library.utoronto.ca jps.library.utoronto.ca/index.php/cpoj/article/view/45122

A FEASIBILITY STUDY - Journal Production Services Group therapy has been shown to improve the mental health of many patient populations, but it has not been widely studied in persons with lower ...

5. researchgate.net researchgate.net/publication/392077270_USING_A_NOVEL_PSYCHOSOCIAL_GROUP_INTERVENTION_TO_IMPROVE_ADAPTION_COPING_AND_MENTAL_HEALTH_OUTCOMES_FOLLOWING_DYSVASCULAR_LIMB_AMPUTATIONS_A_FEASIBILITY_STUDY

Using a novel psychosocial group intervention to improve ... Using a novel psychosocial group intervention to improve adaption, coping and mental health outcomes following dysvascular limb amputations: A ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40904912/

Using a novel psychosocial group intervention to improve ... Background: Individuals with lower extremity amputations (LEA) often face high rates of depression and anxiety that hinder their rehabilitation ...

7. ctv.veeva.com ctv.veeva.com/study/using-a-psychosocial-transitional-group-to-improve-adaptation-coping-and-mental-health-outcomes-fol

Using a Psychosocial Transitional Group to Improve ... People with limb loss receiving inpatient rehabilitation are at greater risk for depression and anxiety, social isolation, and generally ...