Targeted Group-based Psychotherapy to Address Emotional Stress in at Risk ICU Survivors

Targeted Group-based Psychotherapy to Address Emotional Stress in at Risk ICU Survivors: A Pilot Feasibility Study

This study is a pilot clinical trial to assess the feasibility of implementing a group-psychotherapy intervention to modify emotional stress (e.g., anxiety, depression, post-traumatic stress) following ICU hospitalization

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Anxiety; Post Intensive Care Syndrome; Traumatic Stress
• Intervention / Treatment: Behavioral: Managing Stress & Emotions Group (MSEG)

Detailed Description

Psychological symptoms and emotional distress, including anxiety, depression, and posttraumatic stress, are common problems among patients discharged from the intensive care unit (ICU). The presence of psychological distress is associated with poor medical adherence, slower recovery, and reduced quality of life in this patient population. There is a lack of research on evidence-based interventions to address mental health symptoms in ICU patients post-hospitalization. Researchers have recently highlighted the potential utility of peer support/group interventions in the post-ICU recovery process; however, they have yet to be widely tested in interventional trials, and their feasibility and acceptability in the post-ICU population have yet to be demonstrated in a research study. Thus, the purpose of this study is to adapt and deliver a 6-session group-based psychological intervention for post-ICU patients in a single-arm, non-randomized interventional study. Patients' symptoms will be assessed at baseline, post-intervention, and 3-month follow-up. The primary aim of the study is to assess the feasibility and acceptability of the group intervention in the post-ICU patient population. Secondarily, changes in patients' emotional distress will be examined to assess for the impact of the intervention on patients' symptoms.

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine Berg, MD; Phone Number: 617-754-2881; Email: kberg@bidmc.harvard.edu
• Study Contact Backup: Name: Jolin Yamin, PhD; Email: jyamin@bidmc.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged at least 18 years
• ICU stay of at least 3 days
• Access to a smartphone, laptop, or computer and able to participate in a meeting via a virtual platform
• Montreal Cognitive Assessment (MoCA)-BLIND score of at least 18
• English fluency
• Screening questionnaires consistent with clinically significant depression OR anxiety (Hospital Anxiety and Depression Scale-Depression [HADS-D] OR HADS-Anxiety [HADS- A] score of >7) OR Post-traumatic Stress (PTSD Checklist-Civilian Version [PCL-C] score of ≥ 30)
• Resides in the state of Massachusetts.

Exclusion Criteria:

• Unable or unwilling to participate in 6 weekly sessions of group therapy
• Permanent or severe cognitive impairment severe enough to impede participation (as assessed via the MMSE).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Group-Based Psychological Intervention; Single-arm feasibility trial, so all participants will receive the intervention.

Behavioral: Managing Stress & Emotions Group (MSEG); The intervention consists of 6, 90-minute weekly sessions and includes the following components: providing education about psychological and emotional reactions to stress, introducing and practicing coping skills (e.g., mindfulness, emotional awareness, flexible thinking, behavioral modification), decreasing psychological avoidance using emotional exposure, and facilitating group support and discussion (see De Paul & Caver, 2021 for original protocol description).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment	This will be determined by reporting the number of patients who meet study criteria who agreed to participate.	Baseline
Adherence to sessions (acceptability)	This will be determined by reporting the number of intervention sessions completed by each participant.	At 6 weeks (immediately at end of intervention sessions)
Feasibility of data collection at post-treatment	This will be determined by reporting the number of participants who provide post-treatment data.	At 6 weeks (immediately at end of intervention sessions)
Feasibility of data collection at follow-up	This will be determined by reporting the number of participants who provide follow-up data.	At 3 months follow-up
Client Satisfaction Questionnaire	This measure assesses participants' satisfaction with the intervention (participant ratings of 1 to 4, higher scores indicate higher satisfaction).	At 6 weeks (immediately at end of intervention sessions)
Credibility and Expectancy Questionnaire	This measure assesses participants' expectations and beliefs that the intervention will be helpful (Participant ratings of 1 to 9, higher scores indicate higher beliefs that the intervention will be helpful).	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)- Anxiety	This sub-scale of the PROMIS measure assesses participants' anxiety symptoms (Participant ratings of 1 to 5, higher ratings indicate greater anxiety symptoms).	Change from Baseline to immediately Post-Intervention (at 6 weeks), and from Baseline to to 3-months Follow-up
Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)- Depression	This sub-scale of the PROMIS measure assesses participants' depression symptoms (Participant ratings of 1 to 5, higher ratings indicate greater depression symptoms).	Change from Baseline to immediately Post-Intervention (at 6 weeks), and from Baseline to to 3-months Follow-up
PTSD Checklist-Civilian Version (PCL-C)	This measure assesses participants' PTSD symptoms (Participant ratings of 1 to 5, higher ratings indicate greater PTSD symptoms).	Change from Baseline to immediately Post-Intervention (at 6 weeks), and from Baseline to to 3-months Follow-up

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Katherine M Berg, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: May 3, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2023P000087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No