Post Intensive Care SyndromeNCT05856240
Targeted Group-based Psychotherapy to Address Emotional Stress in at Risk ICU Survivors
A study testing Managing Stress & Emotions Group (MSEG) in people with Post Intensive Care Syndrome and Anxiety, run by Beth Israel Deaconess Medical Center.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Intensive Care Syndrome, Anxiety, Traumatic Stress
- What is being tested?
- Managing Stress & Emotions Group (MSEG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: Targeted Group-based Psychotherapy to Address Emotional Stress in at Risk ICU Survivors: A Pilot Feasibility Study
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
Read the 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.
- Conditions
- Post Intensive Care Syndrome, Anxiety, Traumatic Stress, Depression
- Being tested
- Managing Stress & Emotions Group (MSEG)
- Medical subject headings
- postintensive care syndrome, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Managing Stress & Emotions Group (MSEG)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Group-Based Psychological Intervention | Experimental | Single-arm feasibility trial, so all participants will receive the intervention. Receives: Behavioral: Managing Stress & Emotions Group (MSEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
This will be determined by reporting the number of patients who meet study criteria who agreed to participate.
Measured: Baseline
Adherence to sessions (acceptability)
This will be determined by reporting the number of intervention sessions completed by each participant.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline
Secondary outcomes (3)
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).
Measured: 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
This sub-scale of the PROMIS measure assesses participants' depression symptoms (Participant ratings of 1 to 5, higher ratings indicate greater depression symptoms).
Measured: 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)
This measure assesses participants' PTSD symptoms (Participant ratings of 1 to 5, higher ratings indicate greater PTSD symptoms).
Measured: Change from Baseline to immediately Post-Intervention (at 6 weeks), and from Baseline to to 3-months Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study startMay 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Why it stopped: Personnel no longer available to begin study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Intensive Care SyndromeStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Berg, Beth Israel Deaconess Medical Center
- Investigators
- Katherine M Berg, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856240
- Sponsor's protocol ID
- 2023P000087
- Status last verified
- May 2024
- First submitted
- 24 Apr 2023
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Group-based Psychotherapy to Address Emotional Stress in at Risk ICU Survivors: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT05856240
- Acronym / sponsor ID
- 2023P000087
- Conditions
- Post Intensive Care Syndrome, Anxiety, Traumatic Stress, Depression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Personnel no longer available to begin study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group-Based Psychological Intervention | Experimental | Behavioral: Managing Stress & Emotions Group (MSEG)Single-arm feasibility trial, so all participants will receive the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Group-Based Psychological Intervention |
Primary outcome
Feasibility of recruitment
Time frame: Baseline
This will be determined by reporting the number of patients who meet study criteria who agreed to participate.
Adherence to sessions (acceptability)
Time frame: At 6 weeks (immediately at end of intervention sessions)
This will be determined by reporting the number of intervention sessions completed by each participant.
Feasibility of data collection at post-treatment
Time frame: At 6 weeks (immediately at end of intervention sessions)
This will be determined by reporting the number of participants who provide post-treatment data.
Feasibility of data collection at follow-up
Time frame: At 3 months follow-up
This will be determined by reporting the number of participants who provide follow-up data.
Client Satisfaction Questionnaire
Time frame: At 6 weeks (immediately at end of intervention sessions)
This measure assesses participants' satisfaction with the intervention (participant ratings of 1 to 4, higher scores indicate higher satisfaction).
Credibility and Expectancy Questionnaire
Time frame: Baseline
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).
3 secondary outcomes
Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)- Anxiety
Time frame: 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
Time frame: 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)
Time frame: Change from Baseline to immediately Post-Intervention (at 6 weeks), and from Baseline to to 3-months Follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine M Berg, MD principal investigator
Beth Israel Deaconess Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Managing Stress & Emotions Group (MSEG) in people with Post Intensive Care Syndrome and Anxiety, run by Beth Israel Deaconess Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.