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Completed

NCT Number: NCT02691221

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.

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Key information

Conditions

Suicide, Suicidal Ideation Behavior Behavioral Symptoms Self-Injurious Behavior Suicidal Ideation Suicide

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grady Health System

Atlanta, Georgia, 30303, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Relief Link Application Daily Tasks

Behavioral

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 outcomes

  1. Change in scores on 6 item Columbia Suicide Severity Rating Scale Screener (C-SSRS)

    Time frame: Baseline, 6 Months

    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.

  2. Change in scores on 20-item Positive-Negative Affect Scale (PANAS)

    Time frame: Baseline, 6 Months

    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.

  3. Change in scores on 20-item R-UCLA Loneliness Scale

    Time frame: Baseline, 6 Months

    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.

  4. Change in scores on 14-item Mental Health Continuum Short Form (MHC-SF)

    Time frame: Baseline, 6 Months

    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.

  5. Change in scores on 12-item Flourishing Scale (FS)

    Time frame: Baseline, 6 Months

    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.

  6. Change in scores on 8-item Grit-S scale

    Time frame: Baseline, 6 Months

    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.

  7. Change in scores on 10-item Life Orientation Test - Revised

    Time frame: Baseline, 6 Months

    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.

  8. Change in scores on 25-item Connor Davidson Resilience Inventory

    Time frame: Baseline, 6 Months

    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.

  9. Change in scores on 21-item Posttraumatic Growth Inventory

    Time frame: Baseline, 6 Months

    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.

  10. 11-item Effectiveness of Obtaining Resources scale (EOR)

    Time frame: 6 Months

    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.

  11. Number of participants experiencing hospitalizations

    Time frame: 6 Months

    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.

  12. Number of participants experiencing self-injury events

    Time frame: 6 Months

    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 outcomes

  1. Number of participant reported barriers to care and resources

    Time frame: 16 Weeks

    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.

  2. Participant adherence to assigned coping skills activities

    Time frame: 16 Weeks

    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.

  3. Participant adherence to daily mood tracking

    Time frame: 16 Weeks

    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.

  4. Participant usage of resource location functions

    Time frame: 16 Weeks

    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.

  5. Participant positive feedback

    Time frame: 16 Weeks

    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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Georgia Institute of Technology

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 25, 2016
Registry last updated
Dec 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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