search
Back to results

Sensation Awareness Focused Training for Spouses (SAF-T)

Primary Purpose

Post Intensive Care Syndrome, Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SAF-T
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Intensive Care Syndrome focused on measuring intensive care unit, critical care, family, caregiver, actigraphy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • spouse of a critically ill, mechanically ventilated patient
  • within 36 hours of admission to adult Tampa General Hospital (TGH) ICUs
  • understands English

Exclusion Criteria:

  • 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).

Sites / Locations

  • Tampa General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SAF-T Intervention Group

Control Group

Arm Description

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.

The control group will not receive the SAF-T intervention.

Outcomes

Primary Outcome Measures

Change from Baseline Symptoms of Anxiety following ICU discharge and at 1 and 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
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
Impact Event Scale

Secondary Outcome Measures

Sleep
Actiwatch wrist actigraphy
Change from Baseline Symptoms of Stress following ICU discharge and at 1 and 3 months post hospital discharge
Perceived Stress Scale

Full Information

First Posted
February 8, 2017
Last Updated
July 1, 2020
Sponsor
University of South Florida
search

1. Study Identification

Unique Protocol Identification Number
NCT03129204
Brief Title
Sensation Awareness Focused Training for Spouses
Acronym
SAF-T
Official Title
Prevention of Post Intensive Care Syndrome in Family With SAF-T Intervention: Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 3, 2017 (Actual)
Primary Completion Date
February 26, 2018 (Actual)
Study Completion Date
February 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Intensive Care Syndrome, Anxiety, Depression, Posttraumatic Stress Disorder, Sleep Deprivation
Keywords
intensive care unit, critical care, family, caregiver, actigraphy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomized, experimental design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAF-T Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will not receive the SAF-T intervention.
Intervention Type
Behavioral
Intervention Name(s)
SAF-T
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Symptoms of Anxiety following ICU discharge and at 1 and 3 months post hospital discharge
Description
Hospital Anxiety and Depression Scale
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.
Title
Change from Baseline Symptoms of Depression following ICU discharge and at 1 and 3 months post hospital discharge
Description
Hospital Anxiety and Depression Scale
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.
Title
Change from Baseline Symptoms of Post Traumatic Stress Disorder following ICU discharge and at 1 and 3 months post hospital discharge
Description
Impact Event Scale
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.
Secondary Outcome Measure Information:
Title
Sleep
Description
Actiwatch wrist actigraphy
Time Frame
Up to 3 days in the intensive care unit (ICU)
Title
Change from Baseline Symptoms of Stress following ICU discharge and at 1 and 3 months post hospital discharge
Description
Perceived Stress Scale
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: spouse of a critically ill, mechanically ventilated patient within 36 hours of admission to adult Tampa General Hospital (TGH) ICUs understands English Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy L Munro, PhD
Organizational Affiliation
University of South Florida
Official's Role
Study Chair
Facility Information:
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Sensation Awareness Focused Training for Spouses

We'll reach out to this number within 24 hrs