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

NCT05856240 | Withdrawn

• 1 other identifier: 2023P000087
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Post Intensive Care Syndrome; Anxiety; Traumatic Stress; Depression

Outcome Measures

Primary Outcomes (6)

• Feasibility of recruitment

  This will be determined by reporting the number of patients who meet study criteria who agreed to participate.

  Baseline

• 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)

• 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)

• 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

• 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)

• 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 Outcomes (3)

• Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)- Anxiety

  Change from Baseline to immediately Post-Intervention (at 6 weeks), and from Baseline to to 3-months Follow-up

• Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)- Depression

  Change from Baseline to immediately Post-Intervention (at 6 weeks), and from Baseline to to 3-months Follow-up

• PTSD Checklist-Civilian Version (PCL-C)

  Change from Baseline to immediately Post-Intervention (at 6 weeks), and from Baseline to to 3-months Follow-up

Study Arms (1)

Group-Based Psychological Intervention

EXPERIMENTAL

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

Behavioral: Managing Stress & Emotions Group (MSEG)

Interventions

Managing Stress & Emotions Group (MSEG) 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).

Group-Based Psychological Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

MeSH Terms

Conditions

postintensive care syndrome; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Katherine M Berg, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 12, 2023
• Study Start: May 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share