A Recovery-Oriented Counselling Group

NCT03925181 | Completed

• 1 other identifier: REB18-2105
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Intensive Care Recovery

Outcome Measures

Primary Outcomes (6)

• 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).

  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.

  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.

  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.

  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."

  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).

  Pre-test, immediately following 6-week group completion, 3-month, and 6-month.

Secondary Outcomes (2)

• Focus Group

  Immediately following 6-week group completion

• Qualitative Survey

  Immediately following 6-week group completion

Study Arms (2)

Intervention

EXPERIMENTAL

Recovery counselling group.

Behavioral: Counselling Group

Waitlist control

NO INTERVENTION

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

Interventions

Counselling Group 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Long-term hospital stay
• Excluding Criteria for Caregivers:
• \- None

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Health services: collaborator

Study Sites (1)

Calgary ICU Recovery Clinic: Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Study Officials

• Tanya Mudry, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 24, 2019
• Study Start: June 12, 2019
• Primary Completion: December 7, 2021
• Study Completion: August 1, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)