Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00237822
Status:
COMPLETED
Last Update Posted:
2017-10-17
First Post:
2005-10-07
Brief Title:
Increasing Treatment Adherence in Co-Occurring Psychiatric and Drug Use Disorders
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Increasing Treatment Adherence in Co-Occurring Disorders
Status:
COMPLETED
Status Verified Date:
2005-10
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 investigators are proposing a study of treatment adherence in co-occurring psychiatric and drug use disorders COD The proposed study uses a 3-cellcondition design within which 75 adult outpatients with co-occurring psychiatric disorders and drug abusedependence CODDA will be randomly assigned to one of the following brief 8-week manual-guided interventions following a 2-week Assessment Only baseline period
1 Adherence Feedback AF this condition will entail weekly 20-25 minute sessions of AF which is a procedure that represents a technological advancement developed by Cramer et al 1989 1995 and 1999 and is based on the use of adherence data from the microelectronic monitor in Medication Event Monitoring System MEMS caps
2 AF Contingency Management AF CM in this condition participants will receive AF as described above PLUS contingency management CM is based on the behavioral learning theory which suggests that the occurrence of a behavior is increased as a function of the rate at which it is positively reinforced or rewarded or
3 AF Motivational Enhancement Therapy AF MET in this condition patients will receive AF as described above PLUS motivational enhancement therapy MET is based on the idea that an effective way to motivate behavior change is to assist patients in clarifying their ambivalence ie reasons for and against changingadhering utilizing a series of strategies based on client-centered psychotherapy self-efficacy theory and social psychology
The study will allow the evaluation of three hypotheses
1 AF MET is superior to AF CM
2 AF MET is superior to AF alone and
3 AF CM is superior to AF alone
Primary outcome measures are
1 rates of adherence to medication ie selective serotonin reuptake inhibitors or SSRIs as measured by MEMS caps and self-report
2 rates of counseling attendance and
3 reductions in illicit drug use including achievement of abstinence as assessed by twice-weekly urine toxicology tests and self-report
Secondary outcomes include reductions in psychiatric symptomatology and rates of re-hospitalization The investigators will also evaluate the relationship between adherence and primary and secondary outcomes
1 Adherence Feedback AF this condition will entail weekly 20-25 minute sessions of AF which is a procedure that represents a technological advancement developed by Cramer et al 1989 1995 and 1999 and is based on the use of adherence data from the microelectronic monitor in Medication Event Monitoring System MEMS caps
2 AF Contingency Management AF CM in this condition participants will receive AF as described above PLUS contingency management CM is based on the behavioral learning theory which suggests that the occurrence of a behavior is increased as a function of the rate at which it is positively reinforced or rewarded or
3 AF Motivational Enhancement Therapy AF MET in this condition patients will receive AF as described above PLUS motivational enhancement therapy MET is based on the idea that an effective way to motivate behavior change is to assist patients in clarifying their ambivalence ie reasons for and against changingadhering utilizing a series of strategies based on client-centered psychotherapy self-efficacy theory and social psychology
The study will allow the evaluation of three hypotheses
1 AF MET is superior to AF CM
2 AF MET is superior to AF alone and
3 AF CM is superior to AF alone
Primary outcome measures are
1 rates of adherence to medication ie selective serotonin reuptake inhibitors or SSRIs as measured by MEMS caps and self-report
2 rates of counseling attendance and
3 reductions in illicit drug use including achievement of abstinence as assessed by twice-weekly urine toxicology tests and self-report
Secondary outcomes include reductions in psychiatric symptomatology and rates of re-hospitalization The investigators will also evaluate the relationship between adherence and primary and secondary outcomes
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23DA015144 | NIH | None | httpsreporternihgovquickSearchK23DA015144 |