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

Primary Purpose

Post Intensive Care Syndrome, Anxiety, Traumatic Stress

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Managing Stress & Emotions Group (MSEG)
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Intensive Care Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Group-Based Psychological Intervention

    Arm Description

    Single-arm feasibility trial, so all participants will receive the intervention.

    Outcomes

    Primary Outcome Measures

    Feasibility of recruitment
    This will be determined by reporting the number of patients who meet study criteria who agreed to participate.
    Adherence to sessions (acceptability)
    This will be determined by reporting the number of intervention sessions completed by each participant.
    Feasibility of data collection at post-treatment
    This will be determined by reporting the number of participants who provide post-treatment data.
    Feasibility of data collection at follow-up
    This will be determined by reporting the number of participants who provide follow-up data.
    Client Satisfaction Questionnaire
    This measure assesses participants' satisfaction with the intervention (participant ratings of 1 to 4, higher scores indicate higher satisfaction).
    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).

    Secondary Outcome Measures

    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).
    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).
    PTSD Checklist-Civilian Version (PCL-C)
    This measure assesses participants' PTSD symptoms (Participant ratings of 1 to 5, higher ratings indicate greater PTSD symptoms).

    Full Information

    First Posted
    April 24, 2023
    Last Updated
    May 3, 2023
    Sponsor
    Beth Israel Deaconess Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05856240
    Brief Title
    Targeted Group-based Psychotherapy to Address Emotional Stress in at Risk ICU Survivors
    Official Title
    Targeted Group-based Psychotherapy to Address Emotional Stress in at Risk ICU Survivors: A Pilot Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beth Israel Deaconess Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Intensive Care Syndrome, Anxiety, Traumatic Stress, Depression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    34 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group-Based Psychological Intervention
    Arm Type
    Experimental
    Arm Description
    Single-arm feasibility trial, so all participants will receive the intervention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Managing Stress & Emotions Group (MSEG)
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Feasibility of recruitment
    Description
    This will be determined by reporting the number of patients who meet study criteria who agreed to participate.
    Time Frame
    Baseline
    Title
    Adherence to sessions (acceptability)
    Description
    This will be determined by reporting the number of intervention sessions completed by each participant.
    Time Frame
    At 6 weeks (immediately at end of intervention sessions)
    Title
    Feasibility of data collection at post-treatment
    Description
    This will be determined by reporting the number of participants who provide post-treatment data.
    Time Frame
    At 6 weeks (immediately at end of intervention sessions)
    Title
    Feasibility of data collection at follow-up
    Description
    This will be determined by reporting the number of participants who provide follow-up data.
    Time Frame
    At 3 months follow-up
    Title
    Client Satisfaction Questionnaire
    Description
    This measure assesses participants' satisfaction with the intervention (participant ratings of 1 to 4, higher scores indicate higher satisfaction).
    Time Frame
    At 6 weeks (immediately at end of intervention sessions)
    Title
    Credibility and Expectancy Questionnaire
    Description
    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).
    Time Frame
    Baseline
    Secondary Outcome Measure Information:
    Title
    Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)- Anxiety
    Description
    This sub-scale of the PROMIS measure assesses participants' anxiety symptoms (Participant ratings of 1 to 5, higher ratings indicate greater anxiety symptoms).
    Time Frame
    Change from Baseline to immediately Post-Intervention (at 6 weeks), and from Baseline to to 3-months Follow-up
    Title
    Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)- Depression
    Description
    This sub-scale of the PROMIS measure assesses participants' depression symptoms (Participant ratings of 1 to 5, higher ratings indicate greater depression symptoms).
    Time Frame
    Change from Baseline to immediately Post-Intervention (at 6 weeks), and from Baseline to to 3-months Follow-up
    Title
    PTSD Checklist-Civilian Version (PCL-C)
    Description
    This measure assesses participants' PTSD symptoms (Participant ratings of 1 to 5, higher ratings indicate greater PTSD symptoms).
    Time Frame
    Change from Baseline to immediately Post-Intervention (at 6 weeks), and from Baseline to to 3-months Follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Katherine Berg, MD
    Phone
    617-754-2881
    Email
    kberg@bidmc.harvard.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jolin Yamin, PhD
    Email
    jyamin@bidmc.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Katherine M Berg, MD
    Organizational Affiliation
    Beth Israel Deaconess Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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