Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05798091 |
| Other study ID # |
5688 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 28, 2023 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
July 2023 |
| Source |
Sunnybrook Health Sciences Centre |
| Contact |
Oksana Kachmarchuk, MSc |
| Phone |
416-226-6780 |
| Email |
oksana.kachmarchuk[@]sri.utoronto.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
As infection control protocols allow, inpatient participants will participate in a large room
setting at St. John's Rehab seated at least six feet apart and masked, with staff
facilitators. SEGT groups will be capped to having 8 participants per session. If the
pandemic conditions do not enable us to have an in-person group event, the investigators will
explore delivering the intervention via Zoom onsite at St. John's Rehab (delivered by
tablets), where patients can log in private rooms across St. John's Rehab to participate. The
six sessions are based on a current inpatient psychosocial group therapy program being
offered to their inpatients, and will be adapted by our investigation team (PI: Dr. Steinberg
- Psychiatrist), and is based on a program being run at West Park Healthcare Centre for their
limb loss patients.
The sessions will involve facilitated discussion by two allied healthcare professionals or
one psychiatrist and an allied healthcare professional, and will focus on guided discussions
on coping with limb loss, managing sequelae associated with limb loss (e.g., pain), goal
setting and strategies for community living. Based on participant interest, the investigators
may also suggest exercises related to mindfulness and relaxation (e.g., breathing exercises,
etc.). All activities are not physically strenuous and can be done sitting or standing
(depending on participant preference and ability), and combine information sharing by the
group facilitator as well as creating opportunities for group dialogue.
It is hoped that SEGT will influence coping self-efficacy (a "belief in one's ability to cope
with post-traumatic stress demands, and affects various aspects of human functioning through
four processes: cognitive, motivational, affective and environmental selection.").
Self-efficacy is a modifiable construct, and is tied to positive outcomes (less pain,
improved quality of life). Hence, in theory, if our patients develop higher levels of coping
self-efficacy, they will be better equipped in preparing themselves for hospital discharge,
will enhance their self-care and ability to correct maladaptive coping, and display improved
resilience and adaption to life after limb loss; thereby optimizing community reintegration
and decreasing illness burden.
At. St. John's Rehab, 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.).
All admitted LEA inpatients who fulfill eligibility criteria will be approached within 3 days
of admission and invited to participate in the trial, be given a recruitment flyer by a
member of their circle of care, and those who agree to be approached by our research staff to
learn more will then undergo the informed consent process. The research analyst responsible
for recruitment and informed consent will use electronic patient records (SunnyCare) and
liaise with clinical staff to identify new eligible admissions. The clinicians within the
circle of care will still be the first point of contact to approach patients. The analyst
will only approach once a clinician confirms a patient would like to learn more about the
study. SunnyCare access will only be used by the analyst to determine who is newly admitted,
so they can direct clinicians to approach them promptly, rather than wait for a clinician to
inform them of who has been admitted.
After informed consent has been obtained, participants will be assessed using baseline
measures within the first week of their admission. In addition to the primary and secondary
outcomes, data on socio-demographics, impairment, and other relevant medical history (e.g.,
past mental health treatments, etc.) will be collected. All participants, will be asked to
complete a battery of surveys prior to starting the intervention, at post-intervention
(ideally 24-72 hours after intervention), and at 3 months post-discharge. The statistician
analyzing the data will be blinded to group allocation. Prior to beginning the SEGT
intervention, participants will be given a document which highlights the guidelines for
participating in the group. Participants will also be provided an information sheet with
available community resources to help with their mental health. Persons in the SEGT arm will
be invited to complete a qualitative interview 3 months post-discharge to explore their
experiences with the group psychosocial intervention and assess coping. If, during the 3
month follow-up, the patient indicates significant psychological distress or is found to be
at increased risk of mental health deterioration, a psychiatrist (not associated with the
study) will follow-up and direct them to appropriate community resources. The Assertive
Suicidality Action Plan (ASAP) will be followed if a participant expresses suicidal ideation.
It should be noted that since this is a pragmatic trial, some group participants may also be
receiving individual psychiatric supports by a member of the psychiatric team. Our analysis
will control for patients who are receiving both individual and group interventions. No
patient will be denied access to psychiatric care should they agree to participate in the
group. The investigators will ensure that patients receiving the group intervention are not
treated by the same practitioner if they receive individual psychiatric care.
Outcome data from participants will be collected over the phone/Zoom and may be collected
in-person if feasible. The study team will communicate with the inpatient unit manager to
follow all COVID-19 protocols and other infection control policies. If feasible, data
collection may take place in-person for the baseline and post-intervention assessments. If
there are situations that do not allow for the safe collection of data (e.g., physical
distancing, etc.), then the data can be collected over the phone and a staff member will
arrange for a phone line to be used on the unit in private if the patient does not have
access to one. All patient-reported outcome data post-discharge will be collected by phone or
Zoom. In some instances, the interviewer may complete the interviews while working from home.
When the interviewer works from home, they will connect to a Sunnybrook workstation via
Sunnybrook virtual private network (VPN) and initiate a Zoom meeting. The participant will
call in to the Zoom meeting and speak to the interviewer. The interviewer will record the
meeting and save the recording directly to their network drive. Participants will receive a
$25 gift card for their participation.
Block randomization will be used to assign participants to either SEGT or TAU. This type of
randomization is designed to randomize subjects into groups that result in equal sample
sizes. Blocks are small and balanced with predetermined group assignments, which keeps the
numbers of subjects in each group similar at all times. Our team will consult a statistician
to generate the randomization schedule.
A member of the research team who will oversee study operation [Dr. Sander Hitzig -
Co-Investigator] will be responsible for generating the randomization sequence, and will be
blinded to which participants are allocated to which group. A research analyst will be
responsible for collecting the baseline, discharge and 3 month survey data. Since it is
impossible to blind the study participants, The study team will request they not discuss
their group allocation with the coordinator, but it is possible they may inadvertently reveal
this to the coordinator. If the coordinator becomes unblinded then they will make a note and
the coordinator will continue to collect data. However, this has not occurred for our
feasibility trial that preceded the current study, which lowers the likelihood of this
occurring. However, the person analyzing the survey data will be blinded to group allocation
(group 1 versus group 2) only.
A statistician blinded to group allocation will be hired to undertake the analyses. The
analysis will include a descriptive analysis of the main outcome and secondary quantitative
measures. T-tests and repeated measures ANOVA will be used to detect differences on the
outcome measures. The model will include group (SEGT and TAU groups), time (baseline,
discharge and 3-month follow-up) and a group by time interaction term. If the sample sizes
are too small or the data do not meet the assumptions for normality, the non-parametric
equivalents will be applied.
