A Recovery-Oriented Counselling Group

NCT ID: NCT03925181

Last Updated: 2022-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-12

Study Completion Date

2022-08-01

Brief Summary

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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

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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

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Post-Intensive Care Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

Recovery counselling group.

Group Type EXPERIMENTAL

Counselling Group

Intervention Type BEHAVIORAL

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.

Waitlist control

Waitlist control group. Will receive intervention after arm one is complete.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Counselling Group

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.


* Caregiver of an ICU survivor participant meeting criteria above
* Speaks English
* Has a fixed address
* Lives within or surrounding Calgary.

Exclusion Criteria

\- Long-term hospital stay

Excluding Criteria for Caregivers:

\- None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alberta Health services

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Tanya Mudry

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tanya Mudry, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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Calgary ICU Recovery Clinic: Foothills Medical Centre

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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REB18-2105

Identifier Type: -

Identifier Source: org_study_id

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