Suicide, Suicidal IdeationNCT02691221
ReliefLink: A Preventative Mobile Toolkit for Follow-Up Care of Psychiatric Patients
A study testing Relief Link Application Daily Tasks in people with Suicide, Suicidal Ideation, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Suicide, Suicidal Ideation
- What is being tested?
- Relief Link Application Daily Tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Has significant cognitive impairments.
- Is actively psychotic or has an imminently life-threatening medical/psychiatric condition per provider evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Suicide, Suicidal Ideation
- Being tested
- Relief Link Application Daily Tasks
- Keywords
- Suicidal behavior, Mobile Application, Mobile Health Tool
- Medical subject headings
- Suicide, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relief Link Application Daily TasksBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with previous suicide attempt or ideation | Other | 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. Receives: Behavioral: Relief Link Application Daily Tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 Months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Institute of Technology
- Responsible party
- Principal investigator, Nadine Kaslow, PhD, Emory University
- Investigators
- Nadine Kaslow, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691221
- Sponsor's protocol ID
- IRB00083066
- Status last verified
- Dec 2017
- First submitted
- 22 Feb 2016
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReliefLink: A Preventative Mobile Toolkit for Follow-Up Care of Psychiatric Patients
- ClinicalTrials.gov ID
- NCT02691221
- Acronym / sponsor ID
- IRB00083066
- Conditions
- Suicide, Suicidal Ideation
- Keywords
- Suicidal behavior, Mobile Application, Mobile Health Tool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Georgia Institute of Technology
- Study start
- Apr 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with previous suicide attempt or ideation | Other | Behavioral: Relief Link Application Daily TasksParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Has significant cognitive impairments.
- Is actively psychotic or has an imminently life-threatening medical/psychiatric condition per provider evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relief Link Application Daily TasksParticipants 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. | Behavioural | Participants with previous suicide attempt or ideation |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
5 secondary outcomes
Number of participant reported barriers to care and resources
Time frame: 16 Weeks
Participant adherence to assigned coping skills activities
Time frame: 16 Weeks
Participant adherence to daily mood tracking
Time frame: 16 Weeks
Participant usage of resource location functions
Time frame: 16 Weeks
Participant positive feedback
Time frame: 16 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadine Kaslow, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relief Link Application Daily Tasks in people with Suicide, Suicidal Ideation, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scores on 6 item Columbia Suicide Severity Rating Scale Screener (C-SSRS) (time frame: Baseline, 6 Months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2017.