Post Intensive Care SyndromeSAF-TNCT03129204
Sensation Awareness Focused Training for Spouses
A study testing SAF-T in people with Post Intensive Care Syndrome and Anxiety, run by University of South Florida at 1 site in United States.
Trial summary
The purpose of the feasibility study is prevention of Post Intensive Care Syndrome in Family (PICS-F), specifically in spouses of critically ill, mechanically ventilated patients, using a nonpharmacological intervention called Sensation Awareness Focused Training (SĀF-T). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Intensive Care Syndrome, Anxiety, Depression
- What is being tested?
- SAF-T
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2017to 26 Feb 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- spouse of a critically ill, mechanically ventilated patient
- within 36 hours of admission to adult Tampa General Hospital (TGH) ICUs
- understands English
Who cannot join
- anticipation by the clinical provider of imminent patient death
- spouse does not understand English
- spouse is under the age of 18 years old
- spouse is currently receiving treatment for an existing PICS condition (anxiety, depression or PTSD).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Post Intensive Care Syndrome in Family With SAF-T Intervention: Feasibility Study
The purpose of the feasibility study is prevention of Post Intensive Care Syndrome in Family (PICS-F), specifically in spouses of critically ill, mechanically ventilated patients, using a nonpharmacological intervention called Sensation Awareness Focused Training (SĀF-T). This will be accomplished using a prospective, randomized, experimental design to achieve robust and unbiased results.
Read the detailed description
More than 5.7 million patients are admitted to intensive care units (ICU) each year in the United States. The technologically advanced ICU is an unfamiliar frightening environment to patients and their families. Critical illness is a family crisis. There is strong evidence that family distress in response to critical illness does not disappear after ICU discharge. The Society of Critical Care Medicine has identified a cluster of complications that occur in family members of ICU patients as Post Intensive Care Syndrome-Family (PICS-F). PICS in family members of adult ICU survivors includes symptoms of ongoing anxiety, depression, and post-traumatic stress disorder (PTSD). Data suggest that 70% of family members have symptoms of anxiety and 33% have symptoms of depression and PTSD, which can persist for ≥4 years. Moreover, symptoms of anxiety, depression, and PTSD are higher and persist longer in family members than in adult ICU survivors. Because PICS-F occurs with greater frequency in spouses and surrogate health decision-makers, this study will focus on participants whom are spouses of mechanically ventilated critically ill adults (typically sedated and unable to make health decisions).
To date, the focus of PICS-F research has been on description, detection, and prevalence of PICS-F. The approach in the proposed project focuses on prevention of PICS-F using an innovative rapid stress reduction intervention. The Rosenzweig Center for Rapid Recovery has recently developed an adaptation of their Accelerated Resolution Therapy (ART) for psychological trauma and depression, called Sensation Awareness Focused Training (SĀF-T), as an approach to rapidly eliminate negative biological sensations of stress. SĀF-T is designed to elicit a calming response; interrupt negative thoughts, negative feelings, and negative behaviors; and ultimately serve as a self-management stress reduction method for individuals. Lateral left-right (saccadic) eye movements are used to elicit an orienting response that activates an investigatory reflex in which first, an alert response occurs and then, a reflexive pause produces decreased arousal in the face of no threat, which elicits a calming response that rapidly eliminates negative biological sensations of stress. This response process is consistent with behavior of interpretation or reaction to challenge in McEwen's Allostasis Stress Theory. The investigators expect the SĀF-T intervention will enable spouses to better manage stress and reduce risk of PICS-F.
Sleep deprivation has been self-reported as one of the top stressors of family members of ICU patients. Sleep adequacy is defined as a combination of three factors: latency (the time it takes to fall asleep), efficiency ([time spent sleeping ÷ total time in bed] × 100), and duration of sleep. According to the American Academy of Sleep Medicine for adequate sleep, persons should fall asleep within 15 minutes, stay asleep for at least 85% of the time they are in bed, and have a total sleep time of no less than 7 hours. Reasons reported by family members for sleep deprivation include anxiety, tension, and fear. Sleep deprivation may play a role in the development of PICS-F. Although anxiety, tension, and fear are to be expected when a family member is critically ill, acknowledging these feelings and practicing relaxation techniques can reduce the impact that the feelings have on sleep. Therefore, management of stress in spouses throughout the daytime may also improve nighttime sleep/rest and further reduce risk of PICS-F.
- Conditions
- Post Intensive Care Syndrome, Anxiety, Depression, Posttraumatic Stress Disorder, Sleep Deprivation
- Being tested
- SAF-T
- Keywords
- intensive care unit, critical care, family, caregiver, actigraphy
- Medical subject headings
- postintensive care syndrome, Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAF-TBehavioural
The Rosenzweig Center for Rapid Recovery has recently developed an adaptation of their Accelerated Resolution Therapy (ART) for psychological trauma and depression, called Sensation Awareness Focused Training (SĀF-T), as an approach to rapidly eliminate negative biological sensations of stress. SĀF-T is designed to elicit a calming response; interrupt negative thoughts, negative feelings, and negative behaviors; and ultimately serve as a self-management stress reduction tool for individuals.
| Study group | Role | What they receive |
|---|---|---|
| SAF-T Intervention Group | Experimental | The SĀF-T intervention includes coaching from SĀF-T trained research staff on awareness of biological sensations associated with events in the ICU that are perceived stressful. The research staff member will sit across from the participant and ask them to use their eyes to follow hand movements that will induce lateral left-right (saccadic) eye movements to elicit an orienting response that activates an investigatory reflex in which first, an alert response occurs and then, a reflexive pause produces decreased arousal in the face of no threat, which elicits a calming response that rapidly eliminates negative biological sensations of stress. Receives: Behavioral: SAF-T |
| Control Group | No intervention | The control group will not receive the SAF-T intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Symptoms of Anxiety following ICU discharge and at 1 and 3 months post hospital discharge
Hospital Anxiety and Depression Scale
Measured: Four time points: 1) upon study enrollment, 2) at least 24 hours post ICU discharge, 3) 1 month post hospital discharge, and 4) 3 months post hospital discharge.
Change from Baseline Symptoms of Depression following ICU discharge and at 1 and 3 months post hospital discharge
Hospital Anxiety and Depression Scale
Measured: Four time points: 1) upon study enrollment, 2) at least 24 hours post ICU discharge, 3) 1 month post hospital discharge, and 4) 3 months post hospital discharge.
Change from Baseline Symptoms of Post Traumatic Stress Disorder following ICU discharge and at 1 and 3 months post hospital discharge
Impact Event Scale
Measured: Four time points: 1) upon study enrollment, 2) at least 24 hours post ICU discharge, 3) 1 month post hospital discharge, and 4) 3 months post hospital discharge.
Secondary outcomes (2)
Sleep
Actiwatch wrist actigraphy
Measured: Up to 3 days in the intensive care unit (ICU)
Change from Baseline Symptoms of Stress following ICU discharge and at 1 and 3 months post hospital discharge
Perceived Stress Scale
Measured: Four time points: 1) upon study enrollment, 2) at least 24 hours post ICU discharge, 3) 1 month post hospital discharge, and 4) 3 months post hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start3 Sep 2017
- Primary completion26 Feb 2018
- Study completion26 Feb 2018
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, experimental design
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Cairns, PhD, University of South Florida
- Investigators
- Cindy L Munro, PhD, Study chair, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129204
- Sponsor's protocol ID
- Pro00026246
- Acronym
- SAF-T
- Status last verified
- Jul 2020
- First submitted
- 8 Feb 2017
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post Intensive Care Syndrome in Family With SAF-T Intervention: Feasibility Study
- ClinicalTrials.gov ID
- NCT03129204
- Acronym / sponsor ID
- SAF-T / Pro00026246
- Conditions
- Post Intensive Care Syndrome, Anxiety, Depression, Posttraumatic Stress Disorder, Sleep Deprivation
- Keywords
- intensive care unit, critical care, family, caregiver, actigraphy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 3 Sep 2017 (actual)
- Primary completion
- 26 Feb 2018 (actual)
- Study completion
- 26 Feb 2018 (actual)
- First posted
- 26 Apr 2017 (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.
The purpose of the feasibility study is prevention of Post Intensive Care Syndrome in Family (PICS-F), specifically in spouses of critically ill, mechanically ventilated patients, using a nonpharmacological intervention called Sensation Awareness Focused Training (SĀF-T). This will be accomplished using a prospective, randomized, experimental design to achieve robust and unbiased results.
Detailed description
More than 5.7 million patients are admitted to intensive care units (ICU) each year in the United States. The technologically advanced ICU is an unfamiliar frightening environment to patients and their families. Critical illness is a family crisis. There is strong evidence that family distress in response to critical illness does not disappear after ICU discharge. The Society of Critical Care Medicine has identified a cluster of complications that occur in family members of ICU patients as Post Intensive Care Syndrome-Family (PICS-F). PICS in family members of adult ICU survivors includes symptoms of ongoing anxiety, depression, and post-traumatic stress disorder (PTSD). Data suggest that 70% of family members have symptoms of anxiety and 33% have symptoms of depression and PTSD, which can persist for ≥4 years. Moreover, symptoms of anxiety, depression, and PTSD are higher and persist longer in family members than in adult ICU survivors. Because PICS-F occurs with greater frequency in spouses and surrogate health decision-makers, this study will focus on participants whom are spouses of mechanically ventilated critically ill adults (typically sedated and unable to make health decisions).
To date, the focus of PICS-F research has been on description, detection, and prevalence of PICS-F. The approach in the proposed project focuses on prevention of PICS-F using an innovative rapid stress reduction intervention. The Rosenzweig Center for Rapid Recovery has recently developed an adaptation of their Accelerated Resolution Therapy (ART) for psychological trauma and depression, called Sensation Awareness Focused Training (SĀF-T), as an approach to rapidly eliminate negative biological sensations of stress. SĀF-T is designed to elicit a calming response; interrupt negative thoughts, negative feelings, and negative behaviors; and ultimately serve as a self-management stress reduction method for individuals. Lateral left-right (saccadic) eye movements are used to elicit an orienting response that activates an investigatory reflex in which first, an alert response occurs and then, a reflexive pause produces decreased arousal in the face of no threat, which elicits a calming response that rapidly eliminates negative biological sensations of stress. This response process is consistent with behavior of interpretation or reaction to challenge in McEwen's Allostasis Stress Theory. The investigators expect the SĀF-T intervention will enable spouses to better manage stress and reduce risk of PICS-F.
Sleep deprivation has been self-reported as one of the top stressors of family members of ICU patients. Sleep adequacy is defined as a combination of three factors: latency (the time it takes to fall asleep), efficiency ([time spent sleeping ÷ total time in bed] × 100), and duration of sleep. According to the American Academy of Sleep Medicine for adequate sleep, persons should fall asleep within 15 minutes, stay asleep for at least 85% of the time they are in bed, and have a total sleep time of no less than 7 hours. Reasons reported by family members for sleep deprivation include anxiety, tension, and fear. Sleep deprivation may play a role in the development of PICS-F. Although anxiety, tension, and fear are to be expected when a family member is critically ill, acknowledging these feelings and practicing relaxation techniques can reduce the impact that the feelings have on sleep. Therefore, management of stress in spouses throughout the daytime may also improve nighttime sleep/rest and further reduce risk of PICS-F.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, randomized, experimental design
| Arm | Type | Receives |
|---|---|---|
| SAF-T Intervention Group | Experimental | Behavioral: SAF-TThe SĀF-T intervention includes coaching from SĀF-T trained research staff on awareness of biological sensations associated with events in the ICU that are perceived stressful. The research staff member will sit across from the participant and ask them to use their eyes to follow hand movements that will induce lateral left-right (saccadic) eye movements to elicit an orienting response that activates an investigatory reflex in which first, an alert response occurs and then, a reflexive pause produces decreased arousal in the face of no threat, which elicits a calming response that rapidly eliminates negative biological sensations of stress. |
| Control Group | No intervention | –The control group will not receive the SAF-T intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- spouse of a critically ill, mechanically ventilated patient
- within 36 hours of admission to adult Tampa General Hospital (TGH) ICUs
- understands English
Key exclusion criteria (4 listed)
- anticipation by the clinical provider of imminent patient death
- spouse does not understand English
- spouse is under the age of 18 years old
- spouse is currently receiving treatment for an existing PICS condition (anxiety, depression or PTSD).
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 |
|---|---|---|
| SAF-TThe Rosenzweig Center for Rapid Recovery has recently developed an adaptation of their Accelerated Resolution Therapy (ART) for psychological trauma and depression, called Sensation Awareness Focused Training (SĀF-T), as an approach to rapidly eliminate negative biological sensations of stress. SĀF-T is designed to elicit a calming response; interrupt negative thoughts, negative feelings, and negative behaviors; and ultimately serve as a self-management stress reduction tool for individuals. | Behavioural | SAF-T Intervention Group |
Primary outcome
Change from Baseline Symptoms of Anxiety following ICU discharge and at 1 and 3 months post hospital discharge
Time frame: Four time points: 1) upon study enrollment, 2) at least 24 hours post ICU discharge, 3) 1 month post hospital discharge, and 4) 3 months post hospital discharge.
Hospital Anxiety and Depression Scale
Change from Baseline Symptoms of Depression following ICU discharge and at 1 and 3 months post hospital discharge
Time frame: Four time points: 1) upon study enrollment, 2) at least 24 hours post ICU discharge, 3) 1 month post hospital discharge, and 4) 3 months post hospital discharge.
Hospital Anxiety and Depression Scale
Change from Baseline Symptoms of Post Traumatic Stress Disorder following ICU discharge and at 1 and 3 months post hospital discharge
Time frame: Four time points: 1) upon study enrollment, 2) at least 24 hours post ICU discharge, 3) 1 month post hospital discharge, and 4) 3 months post hospital discharge.
Impact Event Scale
2 secondary outcomes
Sleep
Time frame: Up to 3 days in the intensive care unit (ICU)
Change from Baseline Symptoms of Stress following ICU discharge and at 1 and 3 months post hospital discharge
Time frame: Four time points: 1) upon study enrollment, 2) at least 24 hours post ICU discharge, 3) 1 month post hospital discharge, and 4) 3 months post hospital discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
Cindy L Munro, PhD study chair
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAF-T in people with Post Intensive Care Syndrome and Anxiety, run by University of South Florida 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?
The sponsor lists 3 inclusion and 4 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: finished, as of the sponsor's last update on 7 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline Symptoms of Anxiety following ICU discharge and at 1 and 3 months post hospital discharge (time frame: Four time points: 1) upon study enrollment, 2) at least 24 hours post ICU discharge, 3) 1 month post hospital discharge, and 4) 3 months post hospital discharge.). 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?
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 Jul 2020.