Psychosocial Transitional Group Pragmatic Trial

NCT05798091 | Completed

• 1 other identifier: 5688
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change in Patient Health Questionnaire-9 (PHQ-9) scores

  The PHQ-9 is a 9-item questionnaire that is employed to assess and diagnose depression. The instrument score provides a range from 0-27, as each item can be ranked from 0(not at all) to 3 (nearly every day). If 5 or more of the 9 depressive symptoms have been present for "more than half the days" in the past 2 weeks, and 1 of the symptoms is depressed mood or anhedonia, a patient is diagnosed with major depression. Other depression is diagnosed if less than 5 depressive symptoms have been present at least "more than half the days" in the past 2 weeks, and 1 of the symptoms is depressed mood or anhedonia.

  A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge

• Change in Generalized Anxiety Disorder 7-Item (GAD-7) scores

  The GAD-7 is a 7-item self-report questionnaire that examines one's anxiety health status in the past 2 weeks. The instrument scores range from 0-21, as each item can be scored from 0 (not at all) to 3 (nearly every day). A score of 5 indicates mild anxiety, while scores of 10 and 15 indicate moderate and severe anxiety respectively. Referral is recommended for scores that reach 10 or above.

  A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge

Secondary Outcomes (2)

• Change in PTSD Checklist- 5 (PCL-5) scores

  A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge

• Change in Generalized Self-Efficacy Scale (GSE) scores

  A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge

Study Arms (2)

Supportive-expressive group therapy

EXPERIMENTAL

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.

Behavioral: Supportive-expressive group therapy

Treatment as usual

ACTIVE COMPARATOR

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.

Other: Treatment as usual

Interventions

Supportive-expressive group therapy BEHAVIORAL

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.

Also known as: SEGT

Supportive-expressive group therapy

Treatment as usual OTHER

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.).

Also known as: TAU

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking
• years of age or older
• Admitted to St. John's Rehab inpatient
• Any etiology and level limb loss
• Medically stable
• No clinical suspicion of cognitive impairment
• No history of active psychosis or unmanaged major psychiatric disorder

You may not qualify if:

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Research Institute

Toronto, Ontario, M2M 2G1, Canada

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Rosalie Steinberg, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Psychiatrist

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 4, 2023
• Study Start: June 28, 2023
• Primary Completion: February 17, 2025
• Study Completion: February 17, 2025
• Last Updated: May 18, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)