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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05856240
• Other study ID #: 2023P000087
• Status: Withdrawn
• Phase: N/A
• Start date: May 2023
• Est. completion date: March 2024

Study information

• Verified date: May 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety
• Depression
• Post Intensive Care Syndrome
• Stress, Psychological
• Traumatic Stress

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment	This will be determined by reporting the number of patients who meet study criteria who agreed to participate.	Baseline
Primary	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)
Primary	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)
Primary	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
Primary	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)
Primary	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	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
Secondary	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
Secondary	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