AmputationNCT05082870
Using a Psychosocial Transitional Group to Improve Adaptation, Coping and Mental Health Outcomes Following Limb Loss
A study testing Supportive-expressive group therapy (SEGT) in people with Amputation, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amputation
- What is being tested?
- Supportive-expressive group therapy (SEGT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 19 Oct 2021to 21 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Patient Inclusion Criteria:
- English-speaking adult inpatients (18 years and older)
- Dysvascular-related lower extremity amputation
- Medically stable
- No clinical suspicion of cognitive impairment
- No history of active psychosis or unstable severe mental health diagnosis (no diagnosis of schizophrenia, dementia, etc.)
- Admitted inpatients to St. John's Rehab Hospital (Sunnybrook Health Sciences Centre).
Patient Exclusion Criteria:
- Actively suicidal
- Unable participate effectively in a group setting
- Non-dysvascular lower extremity amputation
- Non-English-speaking
- Children (under the age of 18)
- Medically unstable
- Clinical suspicion of cognitive impairment
- History of active psychosis or unstable severe mental health diagnosis (diagnosis of schizophrenia, dementia, etc.)
Staff Inclusion Criteria: (Note: Staff will not be part of intervention, but will be asked to share their perspectives on the intervention)
- Clinical staff who work on the inpatient A1 unit at St. John's Rehab (Sunnybrook Health Sciences Centre)
Staff Exclusion Criteria:
- Casual or contract staff who have worked on the inpatient A1 unit.
- Non-St. John's Rehab Hospital staff
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Lower limb extremity amputation (LEA) is a debilitating event that negatively affects many aspects of an individual's life, such as their mobility, physical and mental health, and ultimately quality of life (QoL). Due to the high rates of diabetes in Canada, the most common type of limb loss is dysvascular due to complications of diabetes/vascular disease.
Compared to other limb loss populations (trauma or tumor), people with dysvascular LEA have been shown to have poorer QoL. Premorbid comorbidities (e.g. coronary heart disease, etc.), and post-morbid complications such as depression, anxiety and chronic pain further impact wellbeing. Sequelae of these issues include impaired body image, and high rates of suicidal ideation. Rates of depression have been found to be as high as 60%; comorbid depression is associated with lower prosthetic use, higher perceived vulnerability, and lower self-rated overall health. Providers, however, often focus efforts on the patients' physical recovery post-LEA and may not adequately address psychosocial functioning.
There is some preliminary evidence on the efficacy of group therapy approaches for limb loss patients undergoing inpatient rehabilitation in India, and outpatient rehabilitation in Canada, but findings are limited and may not be fully generalizable to dysvascular LEA.
Hence, the planned innovative intervention will provide clarification on the feasibility of undertaking a larger scale trial to assess the efficacy of an inpatient group therapy approach to address the mental health concerns (i.e., depression and anxiety) and psychosocial needs (i.e. coping skills) of limb loss patients. Based on available knowledge, this would be the first of its kind in Canada.
- Conditions
- Amputation
- Being tested
- Supportive-expressive group therapy (SEGT)
- Keywords
- Group Intervention, Limb Loss, Feasibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive-expressive group therapy (SEGT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Supportive-expressive group therapy | Experimental | 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. Receives: Behavioral: Supportive-expressive group therapy (SEGT) |
| Treatment as usual | No intervention | The treatment as usual group will receive standard care only (which may include an individual psychiatric consultation). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant recruitment
Number of participants who are recruited into the study and are contacted for assessments at set time intervals.
Measured: Through study completion, an average of 1 year.
Questionnaire completion rates
Number of completed assessments.
Measured: At 3 months post-discharge for SEGT and control group.
Treatment adherence
Number of participants who complete all 6 SEGT sessions.
Measured: Through study completion, an average of 1 year.
Number of participants contacted for follow up interview
Number of participants contacted for follow up interview
Measured: At 1 month-post discharge for SEGT group
Participant retention
Number of participants who complete the 3 month post-discharge assessments
Measured: At three months post-discharge for SEGT and control group
Participant retention
Number of participants who complete 1 month post-discharge interview
Measured: At one month post-discharge for SEGT group
Secondary outcomes (6)
Change in Depression and Anxiety
Hospital Anxiety and Depression Scale: The HADS is a 14-item depression and anxiety screening tool that asks participants to rank the severity of their depression and anxiety symptoms using a 4-point scale (0 to 3). Scores are summed for anxiety items (HADS-A) and for the depression items (HADS-D) with higher scores indicating greater severity of symptoms. The scores are interpreted as normal (range: 0-7), borderline abnormal (range: 8-10), and abnormal (range: 11-21).
Measured: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Change in Self-efficacy
Coping Self-Efficacy Scale:The CSES is a measures perceived self-efficacy for coping with challenges and threats. It is a 26-item measure rated using an 11-point scale with the anchors 0 (cannot do at), 5 (moderately certain can do), and 10 (certain can do). Total scores are calculated by summing the item scores and a higher score indicates higher coping self-efficacy.
Measured: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Change in Body image
Amputee Body Image Scale-Revised: The ABIS-R is a measure of body image perception in people living with limb loss. The measure consists of 14-items scored using the scale 0 (none of the time), 1 (sometimes), and 2 (most/all of the time). Total scores are obtained by reverse scoring three items and summing the item scores.
Measured: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Change in Health-related quality of life
Short Form-36 Survey: The SF-36 is the most widely used generic health-related QoL tool. The tool measures 8 domains including physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, social functioning, general mental health, role limitations due to emotional problems, and vitality. Higher scores on the measure are indicative of less disability.
Measured: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Change in Community participation
Reintegration to Normal Living Index: The RNLI assesses involvement in recreational and social activities, perceived ability to move within the community, and the degree of comfort people have with their relationships. The measure consists of 11 statements and participants are asked to rate each statement on a scale from 1 (Does not describe my situation) to 10 (Fully describes my situation). An adjusted score is calculated producing a score range of 0-100.
Measured: A. 3 months post-discharge
Psychiatric consultations
# of individual psychiatric consultations
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start19 Oct 2021
- Primary completion21 Dec 2022
- Study completion21 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosalie Steinberg, MSC, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082870
- Sponsor's protocol ID
- 1517
- Status last verified
- Jul 2023
- First submitted
- 16 Sep 2021
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pezzin LE, Dillingham TR, MacKenzie EJ. Rehabilitation and the long-term outcomes of persons with trauma-related amputations. Arch Phys Med Rehabil. 2000 Mar;81(3):292-300. doi: 10.1016/s0003-9993(00)90074-1.
PubMed 10724073Fortington LV, Dijkstra PU, Bosmans JC, Post WJ, Geertzen JH. Change in health-related quality of life in the first 18 months after lower limb amputation: a prospective, longitudinal study. J Rehabil Med. 2013 Jun;45(6):587-94. doi: 10.2340/16501977-1146.
PubMed 23624575Turner AP, Meites TM, Williams RM, Henderson AW, Norvell DC, Hakimi KN, Czerniecki JM. Suicidal ideation among individuals with dysvascular lower extremity amputation. Arch Phys Med Rehabil. 2015 Aug;96(8):1404-10. doi: 10.1016/j.apmr.2015.04.001. Epub 2015 Apr 14.
PubMed 25883037Amtmann D, Morgan SJ, Kim J, Hafner BJ. Health-related profiles of people with lower limb loss. Arch Phys Med Rehabil. 2015 Aug;96(8):1474-83. doi: 10.1016/j.apmr.2015.03.024. Epub 2015 Apr 25.
PubMed 25917819Bilandzic A, Rosella L. The cost of diabetes in Canada over 10 years: applying attributable health care costs to a diabetes incidence prediction model. Health Promot Chronic Dis Prev Can. 2017 Feb;37(2):49-53. doi: 10.24095/hpcdp.37.2.03.
PubMed 28273040Moxey PW, Gogalniceanu P, Hinchliffe RJ, Loftus IM, Jones KJ, Thompson MM, Holt PJ. Lower extremity amputations--a review of global variability in incidence. Diabet Med. 2011 Oct;28(10):1144-53. doi: 10.1111/j.1464-5491.2011.03279.x.
PubMed 21388445Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.
PubMed 18295618Padovani MT, Martins MR, Venancio A, Forni JE. Anxiety, depression and quality of life in individuals with phantom limb pain. Acta Ortop Bras. 2015 Mar-Apr;23(2):107-10. doi: 10.1590/1413-78522015230200990.
PubMed 27069411McDonald S, Sharpe L, Blaszczynski A. The psychosocial impact associated with diabetes-related amputation. Diabet Med. 2014 Nov;31(11):1424-30. doi: 10.1111/dme.12474. Epub 2014 May 24.
PubMed 24766143Fleury AM, Salih SA, Peel NM. Rehabilitation of the older vascular amputee: a review of the literature. Geriatr Gerontol Int. 2013 Apr;13(2):264-73. doi: 10.1111/ggi.12016. Epub 2012 Dec 26.
PubMed 23279009Horgan O, MacLachlan M. Psychosocial adjustment to lower-limb amputation: a review. Disabil Rehabil. 2004 Jul 22-Aug 5;26(14-15):837-50. doi: 10.1080/09638280410001708869.
PubMed 15497913Schaffalitzky E, Gallagher P, Maclachlan M, Ryall N. Understanding the benefits of prosthetic prescription: exploring the experiences of practitioners and lower limb prosthetic users. Disabil Rehabil. 2011;33(15-16):1314-23. doi: 10.3109/09638288.2010.529234. Epub 2010 Nov 4.
PubMed 21050130Srivastava K, Chaudhury S. Rehabilitation after amputation: psychotherapeutic intervention module in Indian scenario. ScientificWorldJournal. 2014 Jan 12;2014:469385. doi: 10.1155/2014/469385. eCollection 2014.
PubMed 24526895Delehanty RD, Trachsel L. Effects of short-term group treatment on rehabilitation outcome of adults with amputations. International Journal of Rehabilitation and Health. 1995;1(2):61-73.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Psychosocial Transitional Group to Improve Adaptation, Coping and Mental Health Outcomes Following Limb Loss
- ClinicalTrials.gov ID
- NCT05082870
- Acronym / sponsor ID
- 1517
- Conditions
- Amputation
- Keywords
- Group Intervention, Limb Loss, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lower limb extremity amputation (LEA) is a debilitating event that negatively affects many aspects of an individual's life, such as their mobility, physical and mental health, and ultimately quality of life (QoL). Due to the high rates of diabetes in Canada, the most common type of limb loss is dysvascular due to complications of diabetes/vascular disease.
Compared to other limb loss populations (trauma or tumor), people with dysvascular LEA have been shown to have poorer QoL. Premorbid comorbidities (e.g. coronary heart disease, etc.), and post-morbid complications such as depression, anxiety and chronic pain further impact wellbeing. Sequelae of these issues include impaired body image, and high rates of suicidal ideation. Rates of depression have been found to be as high as 60%; comorbid depression is associated with lower prosthetic use, higher perceived vulnerability, and lower self-rated overall health. Providers, however, often focus efforts on the patients' physical recovery post-LEA and may not adequately address psychosocial functioning.
There is some preliminary evidence on the efficacy of group therapy approaches for limb loss patients undergoing inpatient rehabilitation in India, and outpatient rehabilitation in Canada, but findings are limited and may not be fully generalizable to dysvascular LEA.
Hence, the planned innovative intervention will provide clarification on the feasibility of undertaking a larger scale trial to assess the efficacy of an inpatient group therapy approach to address the mental health concerns (i.e., depression and anxiety) and psychosocial needs (i.e. coping skills) of limb loss patients. Based on available knowledge, this would be the first of its kind in Canada.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive-expressive group therapy | Experimental | 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. |
| Treatment as usual | No intervention | –The treatment as usual group will receive standard care only (which may include an individual psychiatric consultation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Supportive-expressive group therapy |
Primary outcome
Participant recruitment
Time frame: Through study completion, an average of 1 year.
Number of participants who are recruited into the study and are contacted for assessments at set time intervals.
Questionnaire completion rates
Time frame: At 3 months post-discharge for SEGT and control group.
Number of completed assessments.
Treatment adherence
Time frame: Through study completion, an average of 1 year.
Number of participants who complete all 6 SEGT sessions.
Number of participants contacted for follow up interview
Time frame: At 1 month-post discharge for SEGT group
Number of participants contacted for follow up interview
Participant retention
Time frame: At three months post-discharge for SEGT and control group
Number of participants who complete the 3 month post-discharge assessments
Participant retention
Time frame: At one month post-discharge for SEGT group
Number of participants who complete 1 month post-discharge interview
6 secondary outcomes
Change in Depression and Anxiety
Time frame: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Change in Self-efficacy
Time frame: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Change in Body image
Time frame: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Change in Health-related quality of life
Time frame: A. 24-48 hours before intervention (baseline) B. 48-72 hours after intervention ends (discharge) C.3 months post-discharge
Change in Community participation
Time frame: A. 3 months post-discharge
Psychiatric consultations
Time frame: Through study completion, an average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Background: PubMed 10724073Pezzin LE, Dillingham TR, MacKenzie EJ. Rehabilitation and the long-term outcomes of persons with trauma-related amputations. Arch Phys Med Rehabil. 2000 Mar;81(3):292-300. doi: 10.1016/s0003-9993(00)90074-1.
- Background: PubMed 23624575Fortington LV, Dijkstra PU, Bosmans JC, Post WJ, Geertzen JH. Change in health-related quality of life in the first 18 months after lower limb amputation: a prospective, longitudinal study. J Rehabil Med. 2013 Jun;45(6):587-94. doi: 10.2340/16501977-1146.
- Background: PubMed 25883037Turner AP, Meites TM, Williams RM, Henderson AW, Norvell DC, Hakimi KN, Czerniecki JM. Suicidal ideation among individuals with dysvascular lower extremity amputation. Arch Phys Med Rehabil. 2015 Aug;96(8):1404-10. doi: 10.1016/j.apmr.2015.04.001. Epub 2015 Apr 14.
- Background: PubMed 25917819Amtmann D, Morgan SJ, Kim J, Hafner BJ. Health-related profiles of people with lower limb loss. Arch Phys Med Rehabil. 2015 Aug;96(8):1474-83. doi: 10.1016/j.apmr.2015.03.024. Epub 2015 Apr 25.
- Background: PubMed 28273040Bilandzic A, Rosella L. The cost of diabetes in Canada over 10 years: applying attributable health care costs to a diabetes incidence prediction model. Health Promot Chronic Dis Prev Can. 2017 Feb;37(2):49-53. doi: 10.24095/hpcdp.37.2.03.
- Background: PubMed 21388445Moxey PW, Gogalniceanu P, Hinchliffe RJ, Loftus IM, Jones KJ, Thompson MM, Holt PJ. Lower extremity amputations--a review of global variability in incidence. Diabet Med. 2011 Oct;28(10):1144-53. doi: 10.1111/j.1464-5491.2011.03279.x.
- Background: PubMed 18295618Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.
- Background: PubMed 27069411Padovani MT, Martins MR, Venancio A, Forni JE. Anxiety, depression and quality of life in individuals with phantom limb pain. Acta Ortop Bras. 2015 Mar-Apr;23(2):107-10. doi: 10.1590/1413-78522015230200990.
- Background: PubMed 24766143McDonald S, Sharpe L, Blaszczynski A. The psychosocial impact associated with diabetes-related amputation. Diabet Med. 2014 Nov;31(11):1424-30. doi: 10.1111/dme.12474. Epub 2014 May 24.
- Background: PubMed 23279009Fleury AM, Salih SA, Peel NM. Rehabilitation of the older vascular amputee: a review of the literature. Geriatr Gerontol Int. 2013 Apr;13(2):264-73. doi: 10.1111/ggi.12016. Epub 2012 Dec 26.
- Background: PubMed 15497913Horgan O, MacLachlan M. Psychosocial adjustment to lower-limb amputation: a review. Disabil Rehabil. 2004 Jul 22-Aug 5;26(14-15):837-50. doi: 10.1080/09638280410001708869.
- Background: PubMed 21050130Schaffalitzky E, Gallagher P, Maclachlan M, Ryall N. Understanding the benefits of prosthetic prescription: exploring the experiences of practitioners and lower limb prosthetic users. Disabil Rehabil. 2011;33(15-16):1314-23. doi: 10.3109/09638288.2010.529234. Epub 2010 Nov 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosalie Steinberg, MSC, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive-expressive group therapy (SEGT) in people with Amputation, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant recruitment (time frame: Through study completion, an average of 1 year.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05082870, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023; AzTrials last refreshed its copy on 30 Oct 2026.