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

NCT03403738 | Completed DMC

• 1 other identifier: R01MH10764
• Study Type: interventional
• Target: 1,357
• Locations: 1 country
• Sites: 1

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).

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Enhanced usual Care

ACTIVE COMPARATOR

usual care plus comprehensive resource list

Behavioral: enhanced usual care

BBN

EXPERIMENTAL

Bounce Back Now intervention

Behavioral: Bounce Back Now

Interventions

Bounce Back Now BEHAVIORAL

web/smartphone-based intervention for disaster victims

BBN

enhanced usual care BEHAVIORAL

enhanced usual care with list of resources

Enhanced usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 295466, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Kenneth J Ruggiero, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single (outcomes assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: January 19, 2018
• Study Start: December 19, 2017
• Primary Completion: May 6, 2021
• Study Completion: May 6, 2021
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

US (1)