ReliefLink: A Preventative Mobile Toolkit for Follow-Up Care of Psychiatric Patients
Primary Purpose
Suicide, Suicidal Ideation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relief Link Application Daily Tasks
Sponsored by
About this trial
This is an interventional prevention trial for Suicide, Suicidal Ideation focused on measuring Suicidal behavior, Mobile Application, Mobile Health Tool
Eligibility Criteria
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.
Sites / Locations
- Grady Health System
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Participants with previous suicide attempt or ideation
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02691221
First Posted
February 22, 2016
Last Updated
December 13, 2017
Sponsor
Emory University
Collaborators
Georgia Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT02691221
Brief Title
ReliefLink: A Preventative Mobile Toolkit for Follow-Up Care of Psychiatric Patients
Official Title
ReliefLink: A Preventative Mobile Toolkit for Follow-Up Care of Psychiatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Georgia Institute of Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Suicidal Ideation
Keywords
Suicidal behavior, Mobile Application, Mobile Health Tool
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants with previous suicide attempt or ideation
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relief Link Application Daily Tasks
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in scores on 6 item Columbia Suicide Severity Rating Scale Screener (C-SSRS)
Description
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.
Time Frame
Baseline, 6 Months
Title
Change in scores on 20-item Positive-Negative Affect Scale (PANAS)
Description
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.
Time Frame
Baseline, 6 Months
Title
Change in scores on 20-item R-UCLA Loneliness Scale
Description
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.
Time Frame
Baseline, 6 Months
Title
Change in scores on 14-item Mental Health Continuum Short Form (MHC-SF)
Description
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.
Time Frame
Baseline, 6 Months
Title
Change in scores on 12-item Flourishing Scale (FS)
Description
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.
Time Frame
Baseline, 6 Months
Title
Change in scores on 8-item Grit-S scale
Description
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.
Time Frame
Baseline, 6 Months
Title
Change in scores on 10-item Life Orientation Test - Revised
Description
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.
Time Frame
Baseline, 6 Months
Title
Change in scores on 25-item Connor Davidson Resilience Inventory
Description
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.
Time Frame
Baseline, 6 Months
Title
Change in scores on 21-item Posttraumatic Growth Inventory
Description
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.
Time Frame
Baseline, 6 Months
Title
11-item Effectiveness of Obtaining Resources scale (EOR)
Description
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.
Time Frame
6 Months
Title
Number of participants experiencing hospitalizations
Description
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.
Time Frame
6 Months
Title
Number of participants experiencing self-injury events
Description
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.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Number of participant reported barriers to care and resources
Description
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.
Time Frame
16 Weeks
Title
Participant adherence to assigned coping skills activities
Description
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.
Time Frame
16 Weeks
Title
Participant adherence to daily mood tracking
Description
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.
Time Frame
16 Weeks
Title
Participant usage of resource location functions
Description
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.
Time Frame
16 Weeks
Title
Participant positive feedback
Description
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.
Time Frame
16 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadine Kaslow, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Health System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ReliefLink: A Preventative Mobile Toolkit for Follow-Up Care of Psychiatric Patients
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