Clinical trial NCT05856240: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Post Intensive Care Syndrome
Anxiety
Traumatic Stress
Depression
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: Baseline
measure: Adherence to sessions (acceptability)
timeFrame: At 6 weeks (immediately at end of intervention sessions)
measure: Feasibility of data collection at post-treatment
timeFrame: At 6 weeks (immediately at end of intervention sessions)
measure: Feasibility of data collection at follow-up
timeFrame: At 3 months follow-up
measure: Client Satisfaction Questionnaire
timeFrame: At 6 weeks (immediately at end of intervention sessions)
measure: Credibility and Expectancy Questionnaire
timeFrame: Baseline
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)- Anxiety
timeFrame: Change from Baseline to immediately Post-Intervention (at 6 weeks), and from Baseline to to 3-months Follow-up
measure: Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)- Depression
timeFrame: Change from Baseline to immediately Post-Intervention (at 6 weeks), and from Baseline to to 3-months Follow-up
measure: PTSD Checklist-Civilian Version (PCL-C)
timeFrame: Change from Baseline to immediately Post-Intervention (at 6 weeks), and from Baseline to to 3-months Follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Katherine M Berg, MD
role: PRINCIPAL_INVESTIGATOR
References: