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

Beth Israel Lahey Health

Status: Withdrawn

Conditions: Traumatic Stress; Post Intensive Care Syndrome; Depression; Anxiety

Treatments: Behavioral: Managing Stress & Emotions Group (MSEG)

Study type: Interventional

Funder types: Other

Identifiers

NCT05856240

2023P000087

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Group-Based Psychological Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Managing Stress & Emotions Group (MSEG)