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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

A Recovery-Oriented Counselling Group

Clinicaltrials.gov identifier NCT03925181

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted September 26, 2019

Study Description

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.

  • Condition or Disease:Post-Intensive Care Recovery
  • Intervention/Treatment: Behavioral: Counselling Group
  • Phase: N/A
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
  • Study Type: Interventional
  • Estimated Enrollment: 24 participants
  • Allocation: Randomized
  • Intervention Model: Single Group Assignment
  • Intervention 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) ()
  • Primary Purpose: Supportive Care
  • Official Title: A Recovery-Oriented Counselling Group: Supporting Physical, Emotional, and Social Recovery Processes of Critical Care Patients in the ICU Recovery Clinic
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: May 2020
  • Estimated Study Completion Date: May 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Intervention
Recovery counselling group.
Behavioral: 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.
Outcome Measures
  • Primary Outcome Measures: 1. 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).
  • 2. 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.
  • 3. 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.
  • 4. 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.
  • 5. 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."
  • 6. 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).
  • Secondary Outcome Measures: 1. Focus Group [ Time Frame: 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.
  • 2. Qualitative Survey [ Time Frame: 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria for Patients:

- 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.

Inclusion Criteria for Caregivers:

- Caregiver of an ICU survivor participant meeting criteria above

- Speaks English

- Has a fixed address

- Lives within or surrounding Calgary.

Exclusion Criteria for Patients:

- Long-term hospital stay

Excluding Criteria for Caregivers:

- None

Contacts and Locations
Contacts

Contact: Jezz Stone, MSc (403) 210-6995 jmstone@ucalgary.ca

Contact: Tanya Mudry, PhD (403) 210-6995 mudryt@ucalgary.ca

Locations

Canada, Alberta
Calgary ICU Recovery Clinic: Foothills Medical Centre
Calgary

Sponsors and Collaborators

University of Calgary

Alberta Health Services

Investigators

Principal Investigator: Tanya Mudry, PhD University of Calgary

More Information
  • Responsible Party: University of Calgary
  • ClinicalTrials.gov Identifier: NCT03925181 History of Changes
  • Other Study ID Numbers: REB18-2105
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: September 26, 2019
  • Last Verified: September 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No