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Bounce Back Now: A Low-Cost Intervention to Facilitate Post-Disaster Recovery

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bounce Back Now
enhanced usual care
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

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

Inclusion Criteria:

  1. individuals must be aged 18 years and older who were directly or indirectly affected by the disaster.
  2. individual must be at least 18 years of age
  3. have access to an internet-accessible device or computer, and
  4. be English-speaking (i.e., all of the intervention content will be developed in the English language; it is cost-prohibitive to develop the system in multiple language in the testing phase)

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Enhanced usual Care

BBN

Arm Description

usual care plus comprehensive resource list

Bounce Back Now intervention

Outcomes

Primary Outcome Measures

PTSD Checklist-Civilian version (PCL)
20-item scale that assesses symptoms of DSM-defined PTSD.
Patient-Reported Outcomes Measurement Information System (PROMIS)
8-item measure to assess symptoms of depression according to DSM-V criteria.
Behavioral Activation for Depression Scale
25-item measure to assess avoidance behavior as well as pleasant and social activities. Each item is rated on a 7-point Likert scale ranging from 0 (not at all) to 6 (completely). To score the BADS, items from all scales other than the Activation scale are reverse-coded and then all items are summed. To score the subscales, no items are reverse-coded. This process allows high scores on the total scale and the subscales to be represented by the scale and subscale names. In other words, for the total scale, higher scores represent increased activation, while for the Social Impairment subscale, higher scores represent increased social impairment.
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Scale
8-tem measure to assess sleep disturbance and sleep-related impairment. The 8-items are answered on a 5-point Likert scale ranging from 1 (not at all) to 5 (Very much). To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40.
Kessler 6
6-item screening scale for probable serious mental illness (SMI)
The Alcohol Use Disorders Identification Test-Consumption questionnaire (AUDIT-C)
3-item screen that identifies hazardous drinkers or individuals with active alcohol use disorders. The AUDIT-C is scored on a scale of 0-12. Each AUDIT-C question has 5 answer choices. Points allotted are: a = 0 points, b = 1 point, c = 2 points, d = 3 points, e = 4 points. In men, a score of 4 or more is considered positive, optimal for identifying hazardous drinking or active alcohol use disorders. In women, a score of 3 or more is considered positive (same as above). Generally, the higher the score, the more likely it is that the patient's drinking is affecting his or her safety.
Medical Outcomes Study (MOS-SS) Social Support Survey
measures emotional, instrumental and appraisal support

Secondary Outcome Measures

Full Information

First Posted
December 8, 2017
Last Updated
July 22, 2021
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03403738
Brief Title
Bounce Back Now: A Low-Cost Intervention to Facilitate Post-Disaster Recovery
Official Title
Bounce Back Now: A Low-Cost Intervention to Facilitate Post-Disaster Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 19, 2017 (Actual)
Primary Completion Date
May 6, 2021 (Actual)
Study Completion Date
May 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina

4. Oversight

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

5. Study Description

Brief Summary
Disaster survivors need freely accessible resources to self-monitor their emotional recovery and help them address mental health needs they may develop after a disaster. The investigators will evaluate a novel, scalable, and highly sustainable smartphone/web-based intervention that is designed to address post-disaster PTSD and depressed mood. The intervention, Bounce Back Now, will be tested in a study with 5,000 disaster survivors and will be accessible via any internet-connected device (e.g., laptop, tablet, smartphone).
Detailed Description
Globally, an average of 390 disasters, 100,000 related deaths, 260 million disaster victims, and $140 billion in economic damages were recorded per year between 2002-2012. The U.S. is one of the top 5 countries-with China, Philippines, India, and Indonesia-most frequently affected by disasters. The adverse mental health effects of disasters are extraordinary and costly. Up to 38% of distressed survivors presenting to shelters and assistance centers have stress-related and adjustment disorders. Most survivors who develop disaster-related mental health problems do not receive services. The 2013 report of the International Federation of Red Cross and Red Crescent Societies calls for technology-based solutions to heighten access to disaster assistance resources. With US cellphone and smartphone ownership now topping 90% and 60%, respectively, opportunities are tremendous to create cost-efficient, scalable solutions that increase capacity to address mental health needs in disaster-affected communities. The investigators propose highly innovative, time-sensitive research to examine the effectiveness of a widely accessible, technology-based disaster mental health intervention. Mental health recovery trajectories are highly variable in disaster settings. 7,14 Most survivors recover without intervention and may need nothing more than a brief symptom tracking resource (i.e., watchful waiting). Some develop mental health needs (e.g., post-traumatic stress, depression) for which a brief self-help intervention may aid recovery. Some have chronic mental health problems (pre-existing or disaster related) that necessitate formal treatment. Others (e.g., serious mental illness) may require immediate assistance. The proposed intervention, Bounce Back Now (BBN), addresses each level of need using a web/smartphone-based approach that builds on the investigator's prior work. BBN consists of 3 key components: (1) a symptom and activity-tracking component that we piloted in emergency department settings, (2) a self-help intervention that was found to be efficacious in a recent RCT with families affected by a tornado outbreak, and (3) a resource component that principally connects survivors to the SAMHSA-administered Disaster Distress Helpline (DDH) when immediate assistance is needed (e.g., serious mental illness) or when local mental health treatment referrals are needed or preferred. This study will leverage the mental health workforce to recruit 5,000 disaster survivors via partnerships with the American Red Cross (ARC) and Office of the Assistant Secretary for Preparedness and Response (ASPR). These partnerships allow cost-efficient testing of interventions, recruitment of individuals at high risk for developing disaster-related mental health problems, and collection of data at the level of triage to aid in prediction of mental health needs and coordination of care. Participants will be randomly assigned to receive BBN vs. enhanced usual care (i.e., EUC; usual care plus comprehensive resource list). BBN will be optimized for smartphones but accessible from any device with an internet connection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
single (outcomes assessor)
Allocation
Randomized
Enrollment
1357 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced usual Care
Arm Type
Active Comparator
Arm Description
usual care plus comprehensive resource list
Arm Title
BBN
Arm Type
Experimental
Arm Description
Bounce Back Now intervention
Intervention Type
Behavioral
Intervention Name(s)
Bounce Back Now
Intervention Description
web/smartphone-based intervention for disaster victims
Intervention Type
Behavioral
Intervention Name(s)
enhanced usual care
Intervention Description
enhanced usual care with list of resources
Primary Outcome Measure Information:
Title
PTSD Checklist-Civilian version (PCL)
Description
20-item scale that assesses symptoms of DSM-defined PTSD.
Time Frame
we will measure change from baseline and 3, 6, and 12-month post assessment
Title
Patient-Reported Outcomes Measurement Information System (PROMIS)
Description
8-item measure to assess symptoms of depression according to DSM-V criteria.
Time Frame
we will measure change from baseline and 3, 6, and 12-month post assessment
Title
Behavioral Activation for Depression Scale
Description
25-item measure to assess avoidance behavior as well as pleasant and social activities. Each item is rated on a 7-point Likert scale ranging from 0 (not at all) to 6 (completely). To score the BADS, items from all scales other than the Activation scale are reverse-coded and then all items are summed. To score the subscales, no items are reverse-coded. This process allows high scores on the total scale and the subscales to be represented by the scale and subscale names. In other words, for the total scale, higher scores represent increased activation, while for the Social Impairment subscale, higher scores represent increased social impairment.
Time Frame
we will measure change from baseline and 3, 6, and 12-month post assessment
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Scale
Description
8-tem measure to assess sleep disturbance and sleep-related impairment. The 8-items are answered on a 5-point Likert scale ranging from 1 (not at all) to 5 (Very much). To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40.
Time Frame
we will measure change from baseline and 3, 6, and 12-month post assessment
Title
Kessler 6
Description
6-item screening scale for probable serious mental illness (SMI)
Time Frame
we will measure change from baseline and 3, 6, and 12-month post assessment
Title
The Alcohol Use Disorders Identification Test-Consumption questionnaire (AUDIT-C)
Description
3-item screen that identifies hazardous drinkers or individuals with active alcohol use disorders. The AUDIT-C is scored on a scale of 0-12. Each AUDIT-C question has 5 answer choices. Points allotted are: a = 0 points, b = 1 point, c = 2 points, d = 3 points, e = 4 points. In men, a score of 4 or more is considered positive, optimal for identifying hazardous drinking or active alcohol use disorders. In women, a score of 3 or more is considered positive (same as above). Generally, the higher the score, the more likely it is that the patient's drinking is affecting his or her safety.
Time Frame
we will measure change from baseline and 3, 6, and 12-month post assessment
Title
Medical Outcomes Study (MOS-SS) Social Support Survey
Description
measures emotional, instrumental and appraisal support
Time Frame
we will measure change from baseline and 3, 6, and 12-month post assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: individuals must be aged 18 years and older who were directly or indirectly affected by the disaster. individual must be at least 18 years of age have access to an internet-accessible device or computer, and be English-speaking (i.e., all of the intervention content will be developed in the English language; it is cost-prohibitive to develop the system in multiple language in the testing phase)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth J Ruggiero, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
295466
Country
United States

12. IPD Sharing Statement

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Bounce Back Now: A Low-Cost Intervention to Facilitate Post-Disaster Recovery

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