Post-Intensive Care RecoveryNCT03925181
A Recovery-Oriented Counselling Group
A study testing Counselling Group in people with Post-Intensive Care Recovery, run by University of Calgary at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate a recovery-oriented group counselling program for post-discharged critical illness survivors and their caregivers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Intensive Care Recovery
- What is being tested?
- Counselling Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jun 2019to 1 Aug 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
Who may be able to join
- Spent more than 4 days in the ICU,
- Were discharged into the community within 4 months of transfer out of the ICU (excluding patients who were in hospital long-term)
- Speaks English
- Has a fixed address
- Does not have pre-existing psychiatric diagnoses documented in the ICU transfer summary
- Lives within or surrounding Calgary.
Show all 10Show fewer
- Caregiver of an ICU survivor participant meeting criteria above
- Speaks English
- Has a fixed address
- Lives within or surrounding Calgary.
Who cannot join
- Long-term hospital stay
- Excluding Criteria for Caregivers:
- None
Trial locations and contacts
1 site in 1 country.
Canada1 site
Calgary ICU Recovery Clinic: Foothills Medical Centre
Calgary, Alberta, T2N 2T9
About this study
Official title: A Recovery-Oriented Counselling Group: Supporting Physical, Emotional, and Social Recovery Processes of Critical Care Patients in the ICU Recovery Clinic
The purpose of this study is to evaluate a recovery-oriented group counselling program for post-discharged critical illness survivors and their caregivers.
Read the detailed description
The purpose of this pilot project is to develop and evaluate a recovery-oriented counselling group to support the physical, emotional, and social recovery processes of critical care survivors who access the services of the Calgary ICU Recovery Clinics. Upon discharge, critical care survivors are faced with challenges related to their stay in the Intensive Care Unit (ICU), as well as long-term recovery from critical illness. These challenges impact survivors' physical, emotional, social recovery processes, which reduce quality of life, delay (re)integration into their communities, and cause further health problems. Social support and counselling groups show therapeutic promise in supporting recovery processes by increasing social connection, quality of life, acquisition of skills, and emotional and psychological wellbeing.
The purpose of this study is to evaluate a recovery-oriented group counselling program for post-discharged critical illness survivors and their caregivers. The investigators will utilize Substance Abuse and Mental Health Service Administration's (SAMHSA) evidence-based recovery curriculum to develop a counsellor-facilitated recovery-oriented group for patients and caregivers focusing on peer support, relationships, evidence-based strategies, daily life, purpose and meaning-making, strengths, and resilience.
The research objectives are:
- Implement a recovery-oriented counselling group for ICU Recovery Clinic patients and their caregivers.
- Evaluate the recovery-oriented counselling group as situated within the Calgary ICU Recovery Clinic.
The investigators will utilize a Randomized Controlled Trial (RCT) design (non-clinical trial). Participants will be randomized into a treatment (intervention) or wait-list control group. Participants in the wait-list control group will be offered the intervention after the treatment group has completed the intervention group. The investigators will evaluate the intervention through the use of outcomes measures currently used by the ICU Recovery Clinic in a pre-test (t0), immediate post-test (t1), 3-month (t2), and 6-month (t3) follow-ups. In addition, the investigators will conduct a process evaluation of the intervention via content analysis of audio recorded data from semi-structured interviews and focus groups with participants. Patients and caregivers will participate in separate focus groups.
- Conditions
- Post-Intensive Care Recovery
- Being tested
- Counselling Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counselling GroupBehavioural
All sessions will be based off of SAMHSA's recovery curriculum but tailored to the participants recovering from the ICU and their caregivers. Throughout the 6-weeks, the sessions will be holistic, strengths-based, hopeful, respectful, relational, and subjective, while emphasizing social relationships, social contexts, and meaning and purpose.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Recovery counselling group. Receives: Behavioral: Counselling Group |
| Waitlist control | No intervention | Waitlist control group. Will receive intervention after arm one is complete. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Events Scale - Revised (IES-r)
Change of PTSD symptoms. 22 item questionnaire, each scored 0 to 4 points; Scores higher than 24 are concern for PTSD.
3 subscales: intrusion subscale (mean range from 0-4), avoidance subscale (mean range from 0-4), hyperarousal subscale (mean range from 0-4).
Measured: Pre-test, immediately following 6-week group completion, 3-month, and 6-month.
Patient Health Questionnaire (PHQ-9)
Change of symptoms of depression. Nine items, each of which is scored 0 to 3 providing a 0-27 severity score with higher values indicating increased severity of depression.
Measured: Pre-test, immediately following 6-week group completion, 3-month, and 6-month.
Generalized Anxiety Disorder (GAD-7)
Change of symptoms of anxiety. Seven items, each of which is scored 0-3 providing a 0-21 severity score with higher value indicating increased severity of anxiety.
Measured: Pre-test, immediately following 6-week group completion, 3-month, and 6-month.
Godin Leisure Time Activity Questionnaire
Change in activity levels. Participant indicates how many times on average they completed exercise (strenuous, moderate, mild) for more than 15-minutes during a typical 7-day period.
Measured: Pre-test, immediately following 6-week group completion, 3-month, and 6-month.
Euroqol 5 Dimensions (EQ-5D-5L)
Change in health status. Participants select their current experience of health on a visual analog scale (VAS) and descriptive system. The descriptive system consists of a 1-5 severity scale (higher values indicating increased severity) for 5 categories of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The VAS records the participant's self-rated health on a vertical, visual analogue scale where the endpoints are labeled "best imaginable health state" and "worst imaginable health state."
Measured: Pre-test, immediately following 6-week group completion, 3-month, and 6-month.
Employment questionnaire
Change of employment status. Participants indicate whether their recent hospital stay has affected their employment by selecting both their current employment status and employment status prior to their hospital stay (i.e. one of the following: employed full-time, employed part-time, unemployed, home-maker, caregiver, student full-time, student part-time, on disability, retired, other).
Measured: Pre-test, immediately following 6-week group completion, 3-month, and 6-month.
Secondary outcomes (2)
Focus Group
Qualitative semi-structured focus group developed by the researcher to evaluate the program. Topics include: experiences about the group, benefits of the group, examples of changes, and areas of improvement for group development.
Measured: Immediately following 6-week group completion
Qualitative Survey
Qualitative self-report form (not survey or scale) developed by the researcher to on symptomatic changes post-intervention. Questions inquire about: changes in daily activities, fulfillment of roles, social relationships, confidence in coping abilities, changes to routine, participation in leisure activities, hopes for the future, and plans for maintaining recovery.
Measured: Immediately following 6-week group completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start12 Jun 2019
- Primary completion7 Dec 2021
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Intensive Care RecoveryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- In total, 12 ICU survivors will be recruited along with their 12 caregivers. Once participants have been recruited, they (and their caregivers) will be randomly assigned to 2 arms: intervention or no intervention (waitlist control). The waitlist control group will receive the intervention in the second arm after the first intervention arm is complete.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Principal investigator, Tanya Mudry, University of Calgary
- Investigators
- Tanya Mudry, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925181
- Sponsor's protocol ID
- REB18-2105
- Status last verified
- Aug 2022
- First submitted
- 10 Apr 2019
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Recovery-Oriented Counselling Group: Supporting Physical, Emotional, and Social Recovery Processes of Critical Care Patients in the ICU Recovery Clinic
- ClinicalTrials.gov ID
- NCT03925181
- Acronym / sponsor ID
- REB18-2105
- Conditions
- Post-Intensive Care Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 24 Apr 2019 (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.
The purpose of this study is to evaluate a recovery-oriented group counselling program for post-discharged critical illness survivors and their caregivers.
Detailed description
The purpose of this pilot project is to develop and evaluate a recovery-oriented counselling group to support the physical, emotional, and social recovery processes of critical care survivors who access the services of the Calgary ICU Recovery Clinics. Upon discharge, critical care survivors are faced with challenges related to their stay in the Intensive Care Unit (ICU), as well as long-term recovery from critical illness. These challenges impact survivors' physical, emotional, social recovery processes, which reduce quality of life, delay (re)integration into their communities, and cause further health problems. Social support and counselling groups show therapeutic promise in supporting recovery processes by increasing social connection, quality of life, acquisition of skills, and emotional and psychological wellbeing.
The purpose of this study is to evaluate a recovery-oriented group counselling program for post-discharged critical illness survivors and their caregivers. The investigators will utilize Substance Abuse and Mental Health Service Administration's (SAMHSA) evidence-based recovery curriculum to develop a counsellor-facilitated recovery-oriented group for patients and caregivers focusing on peer support, relationships, evidence-based strategies, daily life, purpose and meaning-making, strengths, and resilience.
The research objectives are:
- Implement a recovery-oriented counselling group for ICU Recovery Clinic patients and their caregivers.
- Evaluate the recovery-oriented counselling group as situated within the Calgary ICU Recovery Clinic.
The investigators will utilize a Randomized Controlled Trial (RCT) design (non-clinical trial). Participants will be randomized into a treatment (intervention) or wait-list control group. Participants in the wait-list control group will be offered the intervention after the treatment group has completed the intervention group. The investigators will evaluate the intervention through the use of outcomes measures currently used by the ICU Recovery Clinic in a pre-test (t0), immediate post-test (t1), 3-month (t2), and 6-month (t3) follow-ups. In addition, the investigators will conduct a process evaluation of the intervention via content analysis of audio recorded data from semi-structured interviews and focus groups with participants. Patients and caregivers will participate in separate focus groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In total, 12 ICU survivors will be recruited along with their 12 caregivers. Once participants have been recruited, they (and their caregivers) will be randomly assigned to 2 arms: intervention or no intervention (waitlist control). The waitlist control group will receive the intervention in the second arm after the first intervention arm is complete.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Counselling GroupRecovery counselling group. |
| Waitlist control | No intervention | –Waitlist control group. Will receive intervention after arm one is complete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Spent more than 4 days in the ICU,
- Were discharged into the community within 4 months of transfer out of the ICU (excluding patients who were in hospital long-term)
- Speaks English
- Has a fixed address
- Does not have pre-existing psychiatric diagnoses documented in the ICU transfer summary
Key exclusion criteria (3 listed)
- Long-term hospital stay
- None
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 |
|---|---|---|
| Counselling GroupAll sessions will be based off of SAMHSA's recovery curriculum but tailored to the participants recovering from the ICU and their caregivers. Throughout the 6-weeks, the sessions will be holistic, strengths-based, hopeful, respectful, relational, and subjective, while emphasizing social relationships, social contexts, and meaning and purpose. | Behavioural | Intervention |
Primary outcome
Impact of Events Scale - Revised (IES-r)
Time frame: Pre-test, immediately following 6-week group completion, 3-month, and 6-month.
Change of PTSD symptoms. 22 item questionnaire, each scored 0 to 4 points; Scores higher than 24 are concern for PTSD. 3 subscales: intrusion subscale (mean range from 0-4), avoidance subscale (mean range from 0-4), hyperarousal subscale (mean range from 0-4).
Patient Health Questionnaire (PHQ-9)
Time frame: Pre-test, immediately following 6-week group completion, 3-month, and 6-month.
Change of symptoms of depression. Nine items, each of which is scored 0 to 3 providing a 0-27 severity score with higher values indicating increased severity of depression.
Generalized Anxiety Disorder (GAD-7)
Time frame: Pre-test, immediately following 6-week group completion, 3-month, and 6-month.
Change of symptoms of anxiety. Seven items, each of which is scored 0-3 providing a 0-21 severity score with higher value indicating increased severity of anxiety.
Godin Leisure Time Activity Questionnaire
Time frame: Pre-test, immediately following 6-week group completion, 3-month, and 6-month.
Change in activity levels. Participant indicates how many times on average they completed exercise (strenuous, moderate, mild) for more than 15-minutes during a typical 7-day period.
Euroqol 5 Dimensions (EQ-5D-5L)
Time frame: Pre-test, immediately following 6-week group completion, 3-month, and 6-month.
Change in health status. Participants select their current experience of health on a visual analog scale (VAS) and descriptive system. The descriptive system consists of a 1-5 severity scale (higher values indicating increased severity) for 5 categories of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The VAS records the participant's self-rated health on a vertical, visual analogue scale where the endpoints are labeled "best imaginable health state" and "worst imaginable health state."
Employment questionnaire
Time frame: Pre-test, immediately following 6-week group completion, 3-month, and 6-month.
Change of employment status. Participants indicate whether their recent hospital stay has affected their employment by selecting both their current employment status and employment status prior to their hospital stay (i.e. one of the following: employed full-time, employed part-time, unemployed, home-maker, caregiver, student full-time, student part-time, on disability, retired, other).
2 secondary outcomes
Focus Group
Time frame: Immediately following 6-week group completion
Qualitative Survey
Time frame: Immediately following 6-week group completion
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 9 Aug 2022.
- 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.
Tanya Mudry, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counselling Group in people with Post-Intensive Care Recovery, run by University of Calgary 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?
The sponsor lists 10 inclusion and 3 exclusion criteria. 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 9 Aug 2022. 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?
Impact of Events Scale - Revised (IES-r) (time frame: Pre-test, immediately following 6-week group completion, 3-month, and 6-month.). 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?
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 9 Aug 2022.