ReliefLink: A Preventative Mobile Toolkit for Follow-Up Care of Psychiatric Patients

The purpose of this study is to increase use and availability, as well as assess the feasibility of the ReliefLink (RL) application for use in conjunction with standard care to promote psychological health and prevent suicidal behavior.

Study Overview

• Status: Completed
• Conditions: Suicide, Suicidal Ideation
• Intervention / Treatment: Behavioral: Relief Link Application Daily Tasks

Detailed Description

The aims of this study of ReliefLink application are to determine the utility of ReliefLink self-reports of suicidal ideation, negative emotions, loneliness, subjective well-being, flourishing, mental toughness, positive emotions, learned optimism, resilience, and post-traumatic growth. Additional aims are to evaluate the impact of ReliefLink on perceived access to/usage of care and resources and to explore participant acceptance of ReliefLink as a technological support for standard treatment through human systems engineering of treatment plan adherence and user interview.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Enrolled as patients seeking behavioral health treatment through the Grady Health System
• Speak English
• Sought inpatient and/or outpatient treatment with Grady Health System following a suicide attempt or ideation.
• Has personal access to a functioning iPhone and service plan.

Exclusion Criteria:

• Has significant cognitive impairments.
• Is actively psychotic or has an imminently life-threatening medical/psychiatric condition per provider evaluation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Participants with previous suicide attempt or ideation; Participants will complete daily tasks assigned for completion through a downloaded application on their mobile device and completing six 2-hour long outcome assessment sessions including rater-lead scales over the course of six months.

Behavioral: Relief Link Application Daily Tasks; Participants will complete daily mood tracking and completion of a minimum of one stress management activity per day. Relaxation exercises to choose from on the current version of RL are audio files (i.e., no visuals), and consist of: Guided Meditation, Energizing Breath, Guided Visualization for Relaxation, Progressive Relaxation, Mindfulness Meditation Body Scan, and Mindfulness of Breathing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in scores on 6 item Columbia Suicide Severity Rating Scale Screener (C-SSRS)	A comprehensive, semi-structured interview measure that uniquely measures the full spectrum of suicidality including passive and active suicidal ideation, suicidal intent as well as suicidal behaviors. It rates an individual's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." A higher number of "yes" responses indicated an increased degree of suicidal ideation.	Baseline, 6 Months
Change in scores on 20-item Positive-Negative Affect Scale (PANAS)	Consists of 10 positively and 10 negatively valanced word items. Items are rated by the participant for the extent they are feeling this "right now" on a scale of 1- slightly or not at all through 5- extremely. Total scores can range from 10-50, with higher scores representing higher levels of positive effect and lower scores having negative effect.	Baseline, 6 Months
Change in scores on 20-item R-UCLA Loneliness Scale	A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item on a scale from 1 (Never) to 4 (Often). A higher score indicates an increased degree of loneliness.	Baseline, 6 Months
Change in scores on 14-item Mental Health Continuum Short Form (MHC-SF)	Consists of 14 items and measures the degree of emotional well-being as defined in terms of positive affect/satisfaction with life; social well-being, social acceptance, social actualization, social contribution, social coherence social integration, psychological well-being, personal growth, positive relations with others, purpose in life and self-acceptance. Choices for these items vary between 1 to 7. Individuals who exhibit low levels (i.e., 'never' or 'once or twice' during the past month) on at least one measure of hedonic well-being and low levels on at least six measures of positive functioning are diagnosed with languishing mental health.	Baseline, 6 Months
Change in scores on 12-item Flourishing Scale (FS)	A measure of the participant's self-perceived success in relationships, self-esteem, purpose, and optimism. Items are rated on a seven point rating scale from 1 Strongly disagree to 7 Strongly agree. The scale provides a single psychological well-being score. A lower score indicates a decreased degree of well-being.	Baseline, 6 Months
Change in scores on 8-item Grit-S scale	Measures the individual's tendency to sustain interest in and effort toward very long-term goals. Eight items are assessed using a Likert-like scale (1 = Not like me at all, 5 = Very much like me). There are two sub-scales: Perseverance of Effort and Consistency of Interests. A lower score indicates a decreased decreased levels of perseverance and passion for long-term goals.	Baseline, 6 Months
Change in scores on 10-item Life Orientation Test - Revised	Measures positive and negative expectancies about future events. It consists of 20 statements referring to negative expectancies and 10 statements referring to positive expectancies. Participants answer on a 5-point scale (5 = I agree a lot, 1 = I DISagree a lot). A lower score indicates a decreased degree of life orientation.	Baseline, 6 Months
Change in scores on 25-item Connor Davidson Resilience Inventory	Measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience.	Baseline, 6 Months
Change in scores on 21-item Posttraumatic Growth Inventory	Self-reported measure of post-traumatic growth on a scale of 0 (Did not experience change as a result of their crisis) to 5 (experienced to a very great degree as a result of their crisis). A lower score indicates a decreased degree of posttraumatic growth.	Baseline, 6 Months
11-item Effectiveness of Obtaining Resources scale (EOR)	Calculates the mean of the effectiveness scores for obtaining resources from 11 different types of community resources including mental health treatment, church or clergy, health care, legal services, police, or social services.	6 Months
Number of participants experiencing hospitalizations	Number of hospitalizations self-reported by participants during semi-structured interview. No or infrequent hospitalizations would indicate successful support for the participant via the RL app.	6 Months
Number of participants experiencing self-injury events	Number of self-injury events reported during semi-structured interview. No or infrequent self-injury events would indicate successful support for the participant via the RL app.	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participant reported barriers to care and resources	The number of participant reported barriers to care and resources will be gathered through mobile phone internal usage data coded and a semi-structured interview. Acceptance of ReliefLink as a treatment resource would be suggested if there aren't significant reported barriers.	16 Weeks
Participant adherence to assigned coping skills activities	The frequency of Participant adherence to assigned coping skills activities will be gathered through mobile phone internal usage data coded and a semi-structured interview. Acceptance of ReliefLink as a treatment resource would be suggested if there was significant participant adherence.	16 Weeks
Participant adherence to daily mood tracking	The degree of Participant adherence to daily mood tracking will be gathered through mobile phone internal usage data coded and a semi-structured interview. Acceptance of ReliefLink as a treatment resource would be suggested if there is significant adherence to mood tracking.	16 Weeks
Participant usage of resource location functions	The frequency of Participant usage of resource location functions will be gathered through mobile phone internal usage data coded and a semi-structured interview. Acceptance of ReliefLink as a treatment resource would be suggested if is significant participant usage.	16 Weeks
Participant positive feedback	Participant positive feedback will be gathered through a semi-structured interview. Acceptance of ReliefLink as a treatment resource would be suggested if there is positive participant feedback received.	16 Weeks

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Georgia Institute of Technology
• Investigators: Principal Investigator: Nadine Kaslow, PhD, Emory University

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: February 22, 2016
• First Posted (Estimate): February 25, 2016

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Suicidal behavior, Mobile Application, Mobile Health Tool
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: IRB00083066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO