Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05791643
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2023-03-07
Brief Title:
Promoting Safety Plan and Coping Strategy Use Among Adults with Suicidal Thoughts
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Pilot Micro-Randomized Trial of a Real-Time Intervention for Promoting Safety Plan and Coping Strategy Use for Suicidal Thoughts
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to learn about a new real-time smartphone-based intervention aimed to decrease risk for suicide in adults who have been hospitalized for suicidal thoughts or behaviors The main questions the investigators aim to answer are
Is a real-time smartphone-based intervention that promotes the use of safety plans and other coping strategies for suicidal thoughts feasible and acceptable
Does the real-time intervention result in increased use of safety plans and other coping strategies and reduce suicidal thoughts
Participants will
Answer questions about current suicidal thoughts on their smartphone up to 6 times each day while they are in the hospital and during the 4 weeks after they leave the hospital
When they report elevated suicidal thoughts on a smartphone survey be randomly assigned to receive or not receive automated interactive reminders to use content from their personalized safety plan or general coping strategies
Answer brief follow-up questions on their smartphone within a couple hours of receiving or not receiving automated reminders
Give feedback on their experience with the real-time intervention
Is a real-time smartphone-based intervention that promotes the use of safety plans and other coping strategies for suicidal thoughts feasible and acceptable
Does the real-time intervention result in increased use of safety plans and other coping strategies and reduce suicidal thoughts
Participants will
Answer questions about current suicidal thoughts on their smartphone up to 6 times each day while they are in the hospital and during the 4 weeks after they leave the hospital
When they report elevated suicidal thoughts on a smartphone survey be randomly assigned to receive or not receive automated interactive reminders to use content from their personalized safety plan or general coping strategies
Answer brief follow-up questions on their smartphone within a couple hours of receiving or not receiving automated reminders
Give feedback on their experience with the real-time intervention
Detailed Description:
Effective scalable interventions for the highest-risk time for suicide - after inpatient psychiatric hospitalization - are urgently needed The safety planning intervention Stanley Brown 2012 involves developing a personalized list of prioritized coping strategies for suicidal crises and has been shown to prevent suicidal behavior eg Nuij et al 2021 However roughly 40 of patients with a safety plan never use it Stanley et al 2016 The safety plan also includes multiple components eg different internal coping strategies seeking social support yet little is known about the internal and external contexts that may impact the accessibility and effectiveness of individual safety plan components Improving both the ability to promote safety plan use when needed and the understanding of when specific coping strategies are most accessible and effective has the potential to optimize this already evidence-based intervention
The aim of this study is to leverage the recent micro-randomized trial MRT design Klasnja et al 2015 to evaluate the proximal effects of automated interactive smartphone-based reminders to implement the safety plan and its coping strategies at different levels of suicidal urges and intent Twenty-five N 25 adults hospitalized for suicidal thoughts or behaviors will undergo an intensive longitudinal monitoring protocol which includes completing up to six brief smartphone surveys per day that assess momentary suicidal urges and intent on a 0 to 10 scale during hospitalization and the 28 days after discharge After each post-discharge survey with reported high intensity suicidal urges or moderate intent participants will be micro-randomized to receive either a series of automated interactive intervention messages or no intervention Whether the message content is personalized from the individuals safety plan or general top-rated from others safety plans and the specific coping strategy types recommended will also be randomized Brief proximal follow-up surveys will assess coping strategy use since the last survey prompting micro-randomization perceived helpfulness of any coping strategies used and momentary suicidal urges and intent Qualitative and quantitative data on acceptability and feasibility will be collected from participants and used to inform future real-time intervention refinements Preliminary efficacy data will be used to inform the development of future larger-scale studies and the ultimate development of policies for novel just-in-time adaptive interventions that deliver the right time of support at the right time and in the right context for individuals at risk for suicide
The aim of this study is to leverage the recent micro-randomized trial MRT design Klasnja et al 2015 to evaluate the proximal effects of automated interactive smartphone-based reminders to implement the safety plan and its coping strategies at different levels of suicidal urges and intent Twenty-five N 25 adults hospitalized for suicidal thoughts or behaviors will undergo an intensive longitudinal monitoring protocol which includes completing up to six brief smartphone surveys per day that assess momentary suicidal urges and intent on a 0 to 10 scale during hospitalization and the 28 days after discharge After each post-discharge survey with reported high intensity suicidal urges or moderate intent participants will be micro-randomized to receive either a series of automated interactive intervention messages or no intervention Whether the message content is personalized from the individuals safety plan or general top-rated from others safety plans and the specific coping strategy types recommended will also be randomized Brief proximal follow-up surveys will assess coping strategy use since the last survey prompting micro-randomization perceived helpfulness of any coping strategies used and momentary suicidal urges and intent Qualitative and quantitative data on acceptability and feasibility will be collected from participants and used to inform future real-time intervention refinements Preliminary efficacy data will be used to inform the development of future larger-scale studies and the ultimate development of policies for novel just-in-time adaptive interventions that deliver the right time of support at the right time and in the right context for individuals at risk for suicide
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None