A Recovery-Oriented Counselling Group

Not Applicable

Completed

• Conditions: Post-Intensive Care Recovery
• Interventions: Behavioral: Counselling Group

• Registration Number: NCT03925181
• Lead Sponsor: University of Calgary

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-22
• Study First Posted: 2019-04-24
• Study Start: 2019-06-12
• Primary Completion: 2021-12-07
• Status Verified: 2022-08
• Study Completion: 2022-08-01
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Counselling Group	Recovery counselling group.

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9)	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)	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	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)	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)	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	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 Outcome Measures

Name	Time	Method
Qualitative Survey	Immediately following 6-week group completion	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.
Focus Group	Immediately following 6-week group completion	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.

Trial Locations

Locations (1)

Calgary ICU Recovery Clinic: Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada