Depression Clinical Trial
Official title:
Targeted Group-based Psychotherapy to Address Emotional Stress in at Risk ICU Survivors: A Pilot Feasibility Study
NCT number | NCT05856240 |
Other study ID # | 2023P000087 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2023 |
Est. completion date | March 2024 |
Verified date | May 2024 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Withdrawn |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). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center |
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 |
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