Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631183
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Behavioral Study to Predict the Efficacy of a Self-help Tool
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Behavioral Study to Predict the Efficacy of a Self-help Tool
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to examine whether the investigators can predict on the level of individual participants who have symptoms of depression who will benefit more from self-help tools based on principles of behavioral activation vs cognitive restructuring in terms of a greater decrease of self-reported symptoms The investigators use a combination of self-reported clinical information and behavior on learning and decision-making tasks to predict change in symptom scores
Detailed Description:
Background
Cognitive-Behavioral Therapy CBT is a learning-based psychotherapy treatment that has been established as effective treatment for depression It consists of two core interventions cognitive restructuring CR and behavioral activation BA In recent years internet-delivered CBT iCBT has been developed which allows for dissemination of standardized evidence-based CBT treatments at scale
Virtually all psychotherapy methods aim to teach clients something new new behavioral or thought patterns new responses to triggers and situations andor new emotional reactions As such learning-based psychotherapies modify targeted brain circuits to the extent that these circuits show flexibility and are amenable to change through learning The human brain has several learning circuitsmechanisms that work in parallel Different people will have more flexibility and learn more effectively through some learning mechanisms and not others Because different psychotherapy methods eg BA and CR rely on different types of learning the investigators hypothesize that by characterizing what learning mechanisms are most available and efficient for each person will allow us to predict what intervention method will be most effective for that person
The goal of this study is to test if peoples individual learning propensities can predict what type of intervention will benefit them more
Detailed study design
In a fully online study the investigators deploy several behavioral tasks to assess individual differences in learning and decision-making processes Participants then get access to an internet-based self-help tool for depression that is based on CBT principles and are asked to undergo either the BA modules or the CR modules random assignment 5 weeks of 1-hour session per week The investigators follow up on symptoms at the middle of the period of use of the self-help tool at this point some behavioral tasks are repeated as well at the end of this period and at different times up to a year after finishing use of the self-help tool
Participants are recruited online via advertisement for instance on social media After checking eligibility and obtaining consent online participants are randomized to be part of the discovery or validation dataset the investigators will not analyze the validation dataset until all analyses are pre-registered Participants are then asked to fill out a range of symptom self-report questionnaires and complete a series of behavioral tasks They are then randomized to either a cognitive restructuring group or behavioral activation group All participants are then given access to e-couch a validated self-help tool In the first week all participants complete the depression information submodule from the depression program Over the following four weeks participants in the cognitive restructuring group complete submodules on cognitive restructuring and participants in the behavioral activation group complete submodules on behavioral activation and physical activity After that period participants are free to engage with any of the other modules e-couch offers Participants are additionally asked to fill out symptom self-report questionnaires 1351224 and 48 weeks after the start of e-couch engagement and to repeat a subset of the behavioral tasks 3 weeks after the start of e-couch engagement
All interaction with participants is conducted online via email and possibly via zoom to verify identity or technical advice and online-administered tasks questionnaires and the self-help tool The investigators do not offer any medical advice and forward participants to appropriate sources of support eg hotlines if needed
Quality assurance plan
All data are collected online through our in-house custom-built software The code for the assessments has been reviewed and data quality has been checked prior to study start The code is backed up on a secure server and the investigators can make the code available for review to relevant authorities
Data checks
The investigators use a range of attention checks throughout the study to exclude data from inattentive participants or participants who respond randomly
Statistical analysis plan
Note the goal of this study is not to assess how much the self-help tools affect symptoms on average This has been examined previously and will only be verified in this dataset The primary goal of this study is to develop a tool that predicts for a new individual whose data was not part of the tool development ie out-of-sample what interventions they may benefit more from
When consenting participants are assigned to a discovery or a validation dataset After completing analyses on the discovery dataset the investigators will pre-register a detailed statistical analysis plan and apply that to the validation dataset to confirm and verify any findings Below is the general approach to analyzing the discovery data
Step 1 Compute scores for the self-report scales in line with the literature and fit computational models to data from the behavioral task to retrieve individual model parameters that best explain behavior the behavior from each participant
Step 2 Use prediction models eg elastic nets to predict from the above parameters and scores symptom scores in particular for depression and anhedonia from each participant at the end of the engagement with the self-help tool and during follow ups andor improvement of symptom scores from before to after the engagement with the self-help tool
Step 3 Examine whether change in task behavior due to the first half of engagement with the self-help tool mediates a change in symptoms from before to after that engagement
Cognitive-Behavioral Therapy CBT is a learning-based psychotherapy treatment that has been established as effective treatment for depression It consists of two core interventions cognitive restructuring CR and behavioral activation BA In recent years internet-delivered CBT iCBT has been developed which allows for dissemination of standardized evidence-based CBT treatments at scale
Virtually all psychotherapy methods aim to teach clients something new new behavioral or thought patterns new responses to triggers and situations andor new emotional reactions As such learning-based psychotherapies modify targeted brain circuits to the extent that these circuits show flexibility and are amenable to change through learning The human brain has several learning circuitsmechanisms that work in parallel Different people will have more flexibility and learn more effectively through some learning mechanisms and not others Because different psychotherapy methods eg BA and CR rely on different types of learning the investigators hypothesize that by characterizing what learning mechanisms are most available and efficient for each person will allow us to predict what intervention method will be most effective for that person
The goal of this study is to test if peoples individual learning propensities can predict what type of intervention will benefit them more
Detailed study design
In a fully online study the investigators deploy several behavioral tasks to assess individual differences in learning and decision-making processes Participants then get access to an internet-based self-help tool for depression that is based on CBT principles and are asked to undergo either the BA modules or the CR modules random assignment 5 weeks of 1-hour session per week The investigators follow up on symptoms at the middle of the period of use of the self-help tool at this point some behavioral tasks are repeated as well at the end of this period and at different times up to a year after finishing use of the self-help tool
Participants are recruited online via advertisement for instance on social media After checking eligibility and obtaining consent online participants are randomized to be part of the discovery or validation dataset the investigators will not analyze the validation dataset until all analyses are pre-registered Participants are then asked to fill out a range of symptom self-report questionnaires and complete a series of behavioral tasks They are then randomized to either a cognitive restructuring group or behavioral activation group All participants are then given access to e-couch a validated self-help tool In the first week all participants complete the depression information submodule from the depression program Over the following four weeks participants in the cognitive restructuring group complete submodules on cognitive restructuring and participants in the behavioral activation group complete submodules on behavioral activation and physical activity After that period participants are free to engage with any of the other modules e-couch offers Participants are additionally asked to fill out symptom self-report questionnaires 1351224 and 48 weeks after the start of e-couch engagement and to repeat a subset of the behavioral tasks 3 weeks after the start of e-couch engagement
All interaction with participants is conducted online via email and possibly via zoom to verify identity or technical advice and online-administered tasks questionnaires and the self-help tool The investigators do not offer any medical advice and forward participants to appropriate sources of support eg hotlines if needed
Quality assurance plan
All data are collected online through our in-house custom-built software The code for the assessments has been reviewed and data quality has been checked prior to study start The code is backed up on a secure server and the investigators can make the code available for review to relevant authorities
Data checks
The investigators use a range of attention checks throughout the study to exclude data from inattentive participants or participants who respond randomly
Statistical analysis plan
Note the goal of this study is not to assess how much the self-help tools affect symptoms on average This has been examined previously and will only be verified in this dataset The primary goal of this study is to develop a tool that predicts for a new individual whose data was not part of the tool development ie out-of-sample what interventions they may benefit more from
When consenting participants are assigned to a discovery or a validation dataset After completing analyses on the discovery dataset the investigators will pre-register a detailed statistical analysis plan and apply that to the validation dataset to confirm and verify any findings Below is the general approach to analyzing the discovery data
Step 1 Compute scores for the self-report scales in line with the literature and fit computational models to data from the behavioral task to retrieve individual model parameters that best explain behavior the behavior from each participant
Step 2 Use prediction models eg elastic nets to predict from the above parameters and scores symptom scores in particular for depression and anhedonia from each participant at the end of the engagement with the self-help tool and during follow ups andor improvement of symptom scores from before to after the engagement with the self-help tool
Step 3 Examine whether change in task behavior due to the first half of engagement with the self-help tool mediates a change in symptoms from before to after that engagement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None