Emotion RegulationNCT05408468

Pilot Evaluation of FAMCOPE-ICU (Family Coping and Emotion Regulation Tool in the ICU)

A study testing FAMCOPE-ICU in people with Emotion Regulation and Coping Skills, run by University Hospitals Cleveland Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Having a family member or loved one in the ICU can be a very stressful experience. The investigators have created a tablet-based tool (FAMCOPE-ICU) that is designed to help people in this position cope with this experience. Read more about this study

Who is it for?: Ages 18 to 89 yearsHealthy volunteers can take part
Conditions the study is for: Emotion Regulation, Coping Skills
What is being tested?: FAMCOPE-ICU
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 1 siteUnited States
Study dates: 15 Aug 2022to 27 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 89 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Patient Inclusion Criteria:

18-89 years old
Intensive Care Unit (ICU) length of stay (LOS) >= 48 hours
No anticipated ICU LOS for next 24 hours
Unable to make healthcare decisions

Family Inclusion Criteria

Identified by critical care team as legally authorized representative (LAR)
Able to speak or comprehend English
>= 18 years old

Patient Exclusion Criteria:

Less than 18 years or older than 89 years
ICU LOS < 48 hours
Anticipated ICU discharge within next 24 hours
Able to make healthcare decisions

Family Exclusion Criteria

Not identified by critical care team as the LAR
Unable to speak or comprehend English
< 18 years old

Trial locations and contacts

1 site in 1 country.

United States1 site

University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: Pilot Evaluation of FAMCOPE-ICU

Conditions: Emotion Regulation, Coping Skills
Being tested: FAMCOPE-ICU
Keywords: Critical Care, Informal Caregiving, Surrogate Decision-Making, Self-Regulation
Medical subject headings: Emotional Regulation, Self-Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FAMCOPE-ICUBehavioural
(1) FAMCOPE-ICU is a digital eHealth emotion regulation and coping intervention. FAMCOPE-ICU contains three digital modules representing the three interventional doses. Corresponding with Gross's Extended Process Model of Emotion Regulation, the three respective doses entail assessments, adaptive feedback, and interactive activities pertaining to understanding their affective experiences, learning strategies to regulate emotions and stress, and practicing these skills in a virtual decision-making task. Each dose of the intervention is expected to last 10-15 minutes

Study groups in NCT05408468
Study group	Role	What they receive
FAMCOPE-ICU	Experimental	A digital eHealth emotion regulation and coping intervention. Receives: Behavioral: FAMCOPE-ICU
Usual Care	No intervention	The care and support routinely provided to SDMs of critically ill patients.

What is being measured

The primary outcome is the main question the study is designed to answer.

Acceptability of Intervention Measure
Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)
Measured: After dose 1, 5 minutes
Acceptability of Intervention Measure
Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)
Measured: After dose 2, 5 minutes
Acceptability of Intervention Measure
Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)
Measured: After dose 3, 5 minutes

Secondary outcomes (6)

Change in Anxiety as Measured by PROMIS Anxiety Short Form
Name: PROMIS Item Bank v1.0-Emotional Distress-Anxiety - Short Form 4a Scoring: The four items' responses (ranging from 1 (Never) to 5 (Always) are summed to form a raw score. The raw scores are converted to a T-Score (mean = 50; Standard deviation = 10) derived from a general population.
Interpretation: Higher scores indicate a greater severity in anxiety. Scores less than 55 are "within normal limits", 55-60 are "mild", 60-70 are "moderate", and greater than 70 are "severe".
Measured: Baseline (enrollment), one week.
Change in Depression as Measured by PROMIS Depression Short Form
Name: PROMIS Item Bank v1.0-Emotional Distress-Depression - Short Form 4a Scoring: The four items' responses (ranging from 1 (Never) to 5 (Always) are summed to form a raw score. The raw scores are converted to a T-Score (mean = 50; Standard deviation = 10) derived from a general population.
Interpretation: Higher scores indicate greater severity in depression. Scores less than 55 are "within normal limits," 55-60 are "mild," 60-70 are "moderate," and greater than 70 are "severe."
Measured: Baseline (enrollment), one week.
Sleep Disturbance as Measured by PROMIS Sleep Disturbance Short Form
Name: PROMIS Item Bank v1.0 - Sleep Disturbance - Short Form 8b Scoring: The eight items' responses (ranging from 1 (Never) to 5 (Always) are summed to form a raw score. The raw scores are converted to a T-Score (mean = 50; Standard deviation = 10) derived from a general population.
Interpretation: Higher scores indicate greater severity in anxiety. Scores less than 55 are "within normal limits," 55-60 are "mild," 60-70 are "moderate," and greater than 70 are "severe."
Measured: Baseline (enrollment)
Decision Fatigue Scale
Nine item self-report survey; item responses range from 0 (Strongly Disagree) to 3 (Strongly Agree). Item are summed to form a raw score (range 0-27), with higher scores indicated higher decision fatigue.
Measured: One week post-enrollment
Decisional Conflict Scale
10 item self-report survey; item responses are "yes" (0), "unsure" (2), and "no" (4). Items are summed, divided by 10, multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (high decisional conflict)
Measured: One week post-enrollment
Satisfaction as Measured by the Family Satisfaction in the Intensive Care Unit Scale - 24R
Four item self-report survey; item responses range from 1 (Very dissatisfied) to 5 (Completely satisfied)
Measured: One week post-enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 202227 Jul 2023

First posted7 Jun 2022
Study start15 Aug 2022
Primary completion27 Jul 2023
Study completion27 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Emotion RegulationStudies of the same condition, open and under way.
More trials run by University Hospitals Cleveland 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05408468
Sponsor's protocol ID: STUDY20220055
Other IDs: KL2TR002547
Status last verified: Apr 2026
First submitted: 2 Jun 2022
Last updated: 23 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Emotion Regulation trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Evaluation of FAMCOPE-ICU
ClinicalTrials.gov ID: NCT05408468
Acronym / sponsor ID: STUDY20220055
Conditions: Emotion Regulation, Coping Skills
Keywords: Critical Care, Informal Caregiving, Surrogate Decision-Making, Self-Regulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: University Hospitals Cleveland Medical CenterUniversity, hospital or other
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Study start: 15 Aug 2022 (actual)
Primary completion: 27 Jul 2023 (actual)
Study completion: 27 Jul 2023 (actual)
First posted: 7 Jun 2022 (actual)
Results: Posted 28 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
FAMCOPE-ICU	Experimental	Behavioral: FAMCOPE-ICUA digital eHealth emotion regulation and coping intervention.
Usual Care	No intervention	–The care and support routinely provided to SDMs of critically ill patients.

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

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
FAMCOPE-ICU(1) FAMCOPE-ICU is a digital eHealth emotion regulation and coping intervention. FAMCOPE-ICU contains three digital modules representing the three interventional doses. Corresponding with Gross's Extended Process Model of Emotion Regulation, the three respective doses entail assessments, adaptive feedback, and interactive activities pertaining to understanding their affective experiences, learning strategies to regulate emotions and stress, and practicing these skills in a virtual decision-making task. Each dose of the intervention is expected to last 10-15 minutes	Behavioural	FAMCOPE-ICU

Primary outcome

Acceptability of Intervention Measure
Time frame: After dose 1, 5 minutes
Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)
Acceptability of Intervention Measure
Time frame: After dose 2, 5 minutes
Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)
Acceptability of Intervention Measure
Time frame: After dose 3, 5 minutes
Four item self-report survey; item responses range from 1 (completely disagree) to 5 (completely agree)

6 secondary outcomes

Change in Anxiety as Measured by PROMIS Anxiety Short Form
Time frame: Baseline (enrollment), one week.
Change in Depression as Measured by PROMIS Depression Short Form
Time frame: Baseline (enrollment), one week.
Sleep Disturbance as Measured by PROMIS Sleep Disturbance Short Form
Time frame: Baseline (enrollment)
Decision Fatigue Scale
Time frame: One week post-enrollment
Decisional Conflict Scale
Time frame: One week post-enrollment
Satisfaction as Measured by the Family Satisfaction in the Intensive Care Unit Scale - 24R
Time frame: One week post-enrollment

Results and safety

Results posted to the registry on 28 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FAMCOPE-ICU	29	19
Usual Care	20	17

Primary outcome: Acceptability of Intervention Measure

Time frame: After dose 1, 5 minutes. Mean (Standard Deviation). Unit: units on a scale

Measure	FAMCOPE-ICU n = 24	Usual Care n = 0
Value	4.36 (0.7)	–

Population analysed: Usual care participants did not complete the intervention so no data was collected on them for acceptability of the intervention.

Primary outcome: Acceptability of Intervention Measure

Time frame: After dose 2, 5 minutes. Mean (Standard Deviation). Unit: units on a scale

Measure	FAMCOPE-ICU n = 24	Usual Care n = 0
Value	4.37 (0.69)	–

Population analysed: Usual care participants did not complete the intervention so no data was collected on them for acceptability of the intervention.

Primary outcome: Acceptability of Intervention Measure

Time frame: After dose 3, 5 minutes. Mean (Standard Deviation). Unit: units on a scale

Measure	FAMCOPE-ICU n = 19	Usual Care n = 0
Value	4.27 (1)	–

Population analysed: Usual care participants did not complete the intervention so no data was collected on them for acceptability of the intervention.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: One week post enrollment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FAMCOPE-ICU	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Usual Care	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Emotion Regulation

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Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Recruiting
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Not yet recruitingPhase 2
Clinical Trial Evaluating the Effects of Ganaxolone in Children With Autism
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Recruiting
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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.

Seth A Hoffer, MD principal investigator

University Hospitals Cleveland Medical Center

Grant A Pignatiello, PhD, RN principal investigator

Case Western Reserve University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FAMCOPE-ICU in people with Emotion Regulation and Coping Skills, run by University Hospitals Cleveland Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 28 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Acceptability of Intervention Measure (time frame: After dose 1, 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05408468.

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 23 Apr 2026.