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

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ClinicalTrials.gov Identifier: NCT03403738
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

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).

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Bounce Back Now Behavioral: enhanced usual care Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: single (outcomes assessor)
Primary Purpose: Treatment
Official Title: Bounce Back Now: A Low-Cost Intervention to Facilitate Post-Disaster Recovery
Actual Study Start Date : December 19, 2017
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Enhanced usual Care
usual care plus comprehensive resource list
Behavioral: enhanced usual care
enhanced usual care with list of resources

Experimental: BBN
Bounce Back Now intervention
Behavioral: Bounce Back Now
web/smartphone-based intervention for disaster victims




Primary Outcome Measures :
  1. PTSD Checklist-Civilian version (PCL) [ Time Frame: we will measure change from baseline and 3, 6, and 12-month post assessment ]
    20-item scale that assesses symptoms of DSM-defined PTSD.

  2. Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: we will measure change from baseline and 3, 6, and 12-month post assessment ]
    8-item measure to assess symptoms of depression according to DSM-V criteria.

  3. Behavioral Activation for Depression Scale [ Time Frame: we will measure change from baseline and 3, 6, and 12-month post assessment ]
    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.

  4. Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Scale [ Time Frame: we will measure change from baseline and 3, 6, and 12-month post assessment ]
    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.

  5. Kessler 6 [ Time Frame: we will measure change from baseline and 3, 6, and 12-month post assessment ]
    6-item screening scale for probable serious mental illness (SMI)

  6. The Alcohol Use Disorders Identification Test-Consumption questionnaire (AUDIT-C) [ Time Frame: we will measure change from baseline and 3, 6, and 12-month post assessment ]

    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.


  7. Medical Outcomes Study (MOS-SS) Social Support Survey [ Time Frame: we will measure change from baseline and 3, 6, and 12-month post assessment ]
    measures emotional, instrumental and appraisal support



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403738


Contacts
Contact: R. David Azbill 843-792-3828 azbilld@musc.edu
Contact: Phallan Robbins 843-792-3991 helmy@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 295466
Contact: Kenneth Ruggiero, PhD    842-792-3687    ruggierk@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Kenneth J Ruggiero, PhD Medical University of South Carolina

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03403738     History of Changes
Other Study ID Numbers: R01MH10764
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders