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

NCT ID: NCT05856240

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2024-03-31

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.

Conditions

Post Intensive Care Syndrome; Anxiety; Traumatic Stress; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group-Based Psychological Intervention

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

Group Type: EXPERIMENTAL

Managing Stress & Emotions Group (MSEG)

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Katherine Berg

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine M Berg, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Other Identifiers

2023P000087

Identifier Type: -

Identifier Source: org_study_id