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

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).

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: enhanced usual care; Behavioral: Bounce Back Now

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
• Enrollment (Actual): 1357
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 295466
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Checklist-Civilian version (PCL)	20-item scale that assesses symptoms of DSM-defined PTSD.	we will measure change from baseline and 3, 6, and 12-month post assessment
Patient-Reported Outcomes Measurement Information System (PROMIS)	8-item measure to assess symptoms of depression according to DSM-V criteria.	we will measure change from baseline and 3, 6, and 12-month post assessment
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.	we will measure change from baseline and 3, 6, and 12-month post assessment
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.	we will measure change from baseline and 3, 6, and 12-month post assessment
Kessler 6	6-item screening scale for probable serious mental illness (SMI)	we will measure change from baseline and 3, 6, and 12-month post assessment
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.	we will measure change from baseline and 3, 6, and 12-month post assessment
Medical Outcomes Study (MOS-SS) Social Support Survey	measures emotional, instrumental and appraisal support	we will measure change from baseline and 3, 6, and 12-month post assessment

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Kenneth J Ruggiero, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2017
• Primary Completion (Actual): May 6, 2021
• Study Completion (Actual): May 6, 2021

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: R01MH10764

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No