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Clinical Trials/NCT03925181
NCT03925181
Completed
Not Applicable

A Recovery-Oriented Counselling Group: Supporting Physical, Emotional, and Social Recovery Processes of Critical Care Patients in the ICU Recovery Clinic

University of Calgary1 site in 1 country17 target enrollmentJune 12, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-Intensive Care Recovery
Sponsor
University of Calgary
Enrollment
17
Locations
1
Primary Endpoint
Patient Health Questionnaire (PHQ-9)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 12, 2019
End Date
August 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tanya Mudry

Assistant Professor

University of Calgary

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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).

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).

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.

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."

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.

Secondary Outcomes

  • Qualitative Survey(Immediately following 6-week group completion)
  • Focus Group(Immediately following 6-week group completion)

Study Sites (1)

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