Ignite Creation Date:
2024-07-17 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470698
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-05-24
Brief Title:
EMA for Predicting Treatment Outcomes in Patients With SUD
Sponsor:
University of Huelva
Organization:
University of Huelva
Study Overview
Official Title:
Neuropsychological Assessment in Real Time of the Implicit Cognition in the Prediction of Relapse of Patients With Substance Use Disorder
Status:
RECRUITING
Status Verified Date:
2024-06
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:
TEMPTATION
Brief Summary:
This longitudinal repeated measures study will evaluate participants at the beginning of treatment through an assessment of psychological measures and craving They will be trained to use a mobile platform which will be available for 12 days The assessment will be conducted via Ecological Momentary Assessment EMA with scheduled daily access and during situations of consumption risk Each access will include questions on substance use depression anxiety triggering situations attitude towards drugs and a cognitive bias test The platform will alternate between two tests Drug Stroop Task and WAT-DUD Participants will follow a treatment program supervised by professionals
The study aims to recruit 130 participants 65 for alcohol 65 for cocaine from the Provincial Service for Drug Dependence and Addictions in Huelva SPDA Participants selected via stratified random sampling must reside in Huelva sign informed consent have a compatible mobile device and be over 18 Anonymity will be ensured through alphanumeric codes
Upon treatment admission selected patients will be informed of their participation in the study Interviews conducted by psychologists will outline the study objectives and duration Patients agreeing to participate will sign informed consent and receive an identification code Baseline assessment data will be integrated into a database for subsequent statistical analysis The assessment encompasses the collection of four blocks of information
Block 1 Patients medical history initiated during treatment admission Block 2 Neuropsychological battery developed by the research team for the baseline evaluation
Block 3 Neuropsychological battery developed by the research team for the web platform measured through Ecological Momentary Assessment EMA
Block 4 Follow-up information at three and six months provided by SPDA professionals through the patients medical history
To ensure compliance with participant follow-up a mixed monitoring protocol has been developed which includes phone calls and WhatsApp messages This protocol is designed according to social exchange theory so that participants perceive the benefits of their participation as outweighing the costs
The statistical analysis involves identifying outliers and trimming distributions Data will be averaged per test per person considering different conditions Repeated measures ANOVA will analyze factors such as gender and substance type to address study objectives examining interactions and conducting planned contrasts for specific comparisons
The study aims to recruit 130 participants 65 for alcohol 65 for cocaine from the Provincial Service for Drug Dependence and Addictions in Huelva SPDA Participants selected via stratified random sampling must reside in Huelva sign informed consent have a compatible mobile device and be over 18 Anonymity will be ensured through alphanumeric codes
Upon treatment admission selected patients will be informed of their participation in the study Interviews conducted by psychologists will outline the study objectives and duration Patients agreeing to participate will sign informed consent and receive an identification code Baseline assessment data will be integrated into a database for subsequent statistical analysis The assessment encompasses the collection of four blocks of information
Block 1 Patients medical history initiated during treatment admission Block 2 Neuropsychological battery developed by the research team for the baseline evaluation
Block 3 Neuropsychological battery developed by the research team for the web platform measured through Ecological Momentary Assessment EMA
Block 4 Follow-up information at three and six months provided by SPDA professionals through the patients medical history
To ensure compliance with participant follow-up a mixed monitoring protocol has been developed which includes phone calls and WhatsApp messages This protocol is designed according to social exchange theory so that participants perceive the benefits of their participation as outweighing the costs
The statistical analysis involves identifying outliers and trimming distributions Data will be averaged per test per person considering different conditions Repeated measures ANOVA will analyze factors such as gender and substance type to address study objectives examining interactions and conducting planned contrasts for specific comparisons
Detailed Description:
1 Study design Longitudinal study of repeated measures in which 1 Participants will undergo a baseline assessment at the beginning of treatment which will include psychological measures and craving assessment During this session they will be logged into a platform via their mobile devices and trained in its use The platform will be available from this moment onwards and for the next 12 days 2 At this point the assessment begins through ecological momentary assessment EMA Participants will be required to access the platform once daily during a pre-set time window Daily Assessment DA Participants will also be instructed to access the platform when they experience they are at risk of consuming or acquiring substances Temptation Assessment TA Each access to the platform whether DA or TA will include questions assessing substance use depression subjective anxiety triggering situations attitude toward drugs and a cognitive bias test The application will be programmed to administer one of two cognitive bias tests Drug Stroop Task and WAT-DUD in an alternate sequence for each participant so that each test is administered 6 times to each subject complete within-subjects counterbalancing Throughout the entire study and during the subsequent months participants will engage in a substance use treatment program and clinical professionals from the Provincial Centers for Drug Dependence and Addictions will monitor patients to prevent andor treat potential relapses
2 Participants The study targets to recruit 130 participants 65 for alcohol 65 for cocaine who are receiving treatment for substance use disorder at the Provincial Service for Drug Dependence and Addictions in the province of Huelva SPDA The sample will be selected through stratified random sampling with simple allocation based on the primary drug of consumption and gender To anonymize participant information the application will not collect personal data Participants will be assigned an alphanumeric code for identification
3 Procedures At the time of admission to treatment professionals at addiction treatment centers will inform randomly selected patients that they have been chosen to participate in this study If they agree to participate the interview will commence in a designated room at these centers where the psychologist administering the tests will be present At the outset of the interview participants will be briefed on the project objectives duration and its independent nature from their treatment process and will be asked if they are interested in participating In the event that the patient agrees they will be asked to sign the informed consent form Additionally they will be assigned a code that will only allow their identification by the research team personnel in order to incorporate the gathered information into follow-up assessments Upon completion of the baseline assessment tests all data will be integrated with psychological and neuropsychological tests into a database for subsequent statistical analysis This database will not contain any information enabling patient identification by individuals not involved in the research
The assessment encompasses the collection of four blocks of information
Block 1 Patients medical history initiated during treatment admission The following information will be gathered
a Consumption pattern during the 30 days prior to treatment initiation b Sociodemographic information collected by center professionals
Block 2 Neuropsychological battery developed by the research team for the baseline evaluation The estimated time is 90 minutes including training in the use of the platform The following tests will be used
Questionnaire developed by the research team including sociodemographic information and gender-related variables
StateTrait Depression Inventory IDER Craving Multidimensional Alcohol Craving Scale EMCA Cocaine Craving Questionnaire-Now CCQ-N-10
Monetary Choice Questionnaire MCQ Iowa Gambling Task IGT Balloon Analogue Risk Task BART Impulsive Behavior Scale UPPS-P Anxiety Sensitivity Index ASI-3 Positive and Negative Affect Schedule PANAS Acceptance and Action Questionnaire-II AAQ-II Padua Inventory
Block 3 Neuropsychological battery developed by the research team for the web platform measured through Ecological Momentary Assessment EMA The following tests will be utilized
1 Cognitive bias assessment Each access to the platform DA or TA will include one of these two tests in an alternate sequence for each participant
Drug Stroop Task for mobile devices Word Association Task for Drug Use Disorder WAT-DUD
2 StateTrait Depression Inventory IDER This test is administered on DA on days 2 6 and 10 and on each TA Since the complete test is already administered during the baseline assessment participants will only need to respond to questions related to the State degree of affectation during the EMA assessment
3 Craving assessment The test are administered on days 1 4 8 and 12 and on each TA
Multidimensional Alcohol Craving Scale EMCA Cocaine Craving Questionnaire-Now CCQ-N-10
4 In order to obtain relevant information during the EMA follow-up a series of additional questions are included These questions address the following
Subjective anxiety This question is included at the end of the IDER items Attitude towards the drug These questions are integrated into the craving questionnaires EMCACCQ-N-10
Triggering situation These questions are integrated into the craving questionnaires EMCACCQ-N-10
Consumption during follow-up These questions are presented independently from the rest of the tests before completing each access to the platform
Before concluding the last two blocks related to the developed neuropsychological battery it is worth noting that a series of control questions have been included to ensure greater reliability in participants responses These questions have been included in both the baseline assessment tests and those presented during the EMA follow-up
Block 4 Follow-up information at three and six months provided by SPDA professionals through the patients medical history current situation adherence level level of involvement according to professional assessment current substance use and relapses
To ensure compliance with participant follow-up a mixed monitoring protocol has been developed which includes phone calls and WhatsApp messages This protocol is designed according to social exchange theory so that participants perceive the benefits of their participation as outweighing the costs Once SPDA professionals provide participant contact information and obtain consent for contact an initial contact will be made via WhatsApp to schedule a baseline assessment appointment If there is no response a phone call will be made When participants complete the baseline assessment they will be taught how to use the platform and the time window for data collection will be established Participants will receive a welcome and motivation or pre-notification message which includes elements of personalization and trust tangible and intangible benefits of study participation and cost minimization At the designated time a notification message will be sent reminding participants of access hours and providing a direct link to the platform to minimize response costs If participants do not access the platform daily during the established time window a reminder message will be sent even if they are no longer within the mentioned temporal window This reminder will emphasize the benefits of study participation and provide a link to minimize response costs If despite reminders participants do not access the platform for two consecutive days a phone call will be made to encourage active participation After completing the follow-up a final thank-you message will be sent to participants informing them of the amount of gift cards they will receive They will also be reminded that their participation will help others and improve future interventions
Statistical analysis First an analysis will be conducted to identify outliers in the individual responses to the items of each execution of each PSC Distributions with outliers will be handled by trimming to the 90th percentile transforming the considered outliers to the equivalent of the 5th and 95th percentiles of the distribution Subsequently the average value will be calculated for each test per person based on other variables distinguishing between daily tests and impulse tests as well as tests conducted on days of substance consumption versus days of non-consumption This way each participant will have an estimated value in the performance of each test under different access conditions daily and impulse and under the circumstances of substance consumption or non-consumption To address the study objectives data will be analyzed using a repeated measures ANOVA model This model will have three factors forming different groups of participants gender primary substance and type of admission and two factors of repeated measures type of measurement - impulse or daily - and substance consumption on the day of measurement The full factorial model will be initially analyzed which examines all main effects and all interactions If any of the interactions are statistically significant the results will be analyzed through decomposition into simple effects as well as the estimation of the magnitude of the interaction Comparisons for specific objectives will be conducted through planned contrasts
2 Participants The study targets to recruit 130 participants 65 for alcohol 65 for cocaine who are receiving treatment for substance use disorder at the Provincial Service for Drug Dependence and Addictions in the province of Huelva SPDA The sample will be selected through stratified random sampling with simple allocation based on the primary drug of consumption and gender To anonymize participant information the application will not collect personal data Participants will be assigned an alphanumeric code for identification
3 Procedures At the time of admission to treatment professionals at addiction treatment centers will inform randomly selected patients that they have been chosen to participate in this study If they agree to participate the interview will commence in a designated room at these centers where the psychologist administering the tests will be present At the outset of the interview participants will be briefed on the project objectives duration and its independent nature from their treatment process and will be asked if they are interested in participating In the event that the patient agrees they will be asked to sign the informed consent form Additionally they will be assigned a code that will only allow their identification by the research team personnel in order to incorporate the gathered information into follow-up assessments Upon completion of the baseline assessment tests all data will be integrated with psychological and neuropsychological tests into a database for subsequent statistical analysis This database will not contain any information enabling patient identification by individuals not involved in the research
The assessment encompasses the collection of four blocks of information
Block 1 Patients medical history initiated during treatment admission The following information will be gathered
a Consumption pattern during the 30 days prior to treatment initiation b Sociodemographic information collected by center professionals
Block 2 Neuropsychological battery developed by the research team for the baseline evaluation The estimated time is 90 minutes including training in the use of the platform The following tests will be used
Questionnaire developed by the research team including sociodemographic information and gender-related variables
StateTrait Depression Inventory IDER Craving Multidimensional Alcohol Craving Scale EMCA Cocaine Craving Questionnaire-Now CCQ-N-10
Monetary Choice Questionnaire MCQ Iowa Gambling Task IGT Balloon Analogue Risk Task BART Impulsive Behavior Scale UPPS-P Anxiety Sensitivity Index ASI-3 Positive and Negative Affect Schedule PANAS Acceptance and Action Questionnaire-II AAQ-II Padua Inventory
Block 3 Neuropsychological battery developed by the research team for the web platform measured through Ecological Momentary Assessment EMA The following tests will be utilized
1 Cognitive bias assessment Each access to the platform DA or TA will include one of these two tests in an alternate sequence for each participant
Drug Stroop Task for mobile devices Word Association Task for Drug Use Disorder WAT-DUD
2 StateTrait Depression Inventory IDER This test is administered on DA on days 2 6 and 10 and on each TA Since the complete test is already administered during the baseline assessment participants will only need to respond to questions related to the State degree of affectation during the EMA assessment
3 Craving assessment The test are administered on days 1 4 8 and 12 and on each TA
Multidimensional Alcohol Craving Scale EMCA Cocaine Craving Questionnaire-Now CCQ-N-10
4 In order to obtain relevant information during the EMA follow-up a series of additional questions are included These questions address the following
Subjective anxiety This question is included at the end of the IDER items Attitude towards the drug These questions are integrated into the craving questionnaires EMCACCQ-N-10
Triggering situation These questions are integrated into the craving questionnaires EMCACCQ-N-10
Consumption during follow-up These questions are presented independently from the rest of the tests before completing each access to the platform
Before concluding the last two blocks related to the developed neuropsychological battery it is worth noting that a series of control questions have been included to ensure greater reliability in participants responses These questions have been included in both the baseline assessment tests and those presented during the EMA follow-up
Block 4 Follow-up information at three and six months provided by SPDA professionals through the patients medical history current situation adherence level level of involvement according to professional assessment current substance use and relapses
To ensure compliance with participant follow-up a mixed monitoring protocol has been developed which includes phone calls and WhatsApp messages This protocol is designed according to social exchange theory so that participants perceive the benefits of their participation as outweighing the costs Once SPDA professionals provide participant contact information and obtain consent for contact an initial contact will be made via WhatsApp to schedule a baseline assessment appointment If there is no response a phone call will be made When participants complete the baseline assessment they will be taught how to use the platform and the time window for data collection will be established Participants will receive a welcome and motivation or pre-notification message which includes elements of personalization and trust tangible and intangible benefits of study participation and cost minimization At the designated time a notification message will be sent reminding participants of access hours and providing a direct link to the platform to minimize response costs If participants do not access the platform daily during the established time window a reminder message will be sent even if they are no longer within the mentioned temporal window This reminder will emphasize the benefits of study participation and provide a link to minimize response costs If despite reminders participants do not access the platform for two consecutive days a phone call will be made to encourage active participation After completing the follow-up a final thank-you message will be sent to participants informing them of the amount of gift cards they will receive They will also be reminded that their participation will help others and improve future interventions
Statistical analysis First an analysis will be conducted to identify outliers in the individual responses to the items of each execution of each PSC Distributions with outliers will be handled by trimming to the 90th percentile transforming the considered outliers to the equivalent of the 5th and 95th percentiles of the distribution Subsequently the average value will be calculated for each test per person based on other variables distinguishing between daily tests and impulse tests as well as tests conducted on days of substance consumption versus days of non-consumption This way each participant will have an estimated value in the performance of each test under different access conditions daily and impulse and under the circumstances of substance consumption or non-consumption To address the study objectives data will be analyzed using a repeated measures ANOVA model This model will have three factors forming different groups of participants gender primary substance and type of admission and two factors of repeated measures type of measurement - impulse or daily - and substance consumption on the day of measurement The full factorial model will be initially analyzed which examines all main effects and all interactions If any of the interactions are statistically significant the results will be analyzed through decomposition into simple effects as well as the estimation of the magnitude of the interaction Comparisons for specific objectives will be conducted through planned contrasts
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