Trial Outcomes & Findings for Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression (NCT NCT00356304)

Results Overview

Medication container caps (MEMS) recorded each instance where the antidepressant medication container was opened. An adherence index was derived the represented the percentage of days, within the medication period, where the container was opened.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

50 participants

Primary outcome timeframe

Measured immediately post-treatment and at Months 2 and 5 months follow-ups

Results posted on

2014-05-08

Participant Flow

Participant milestones

Participant milestones
Measure	Motivational Enhancement Therapy for Antidepressants Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.	Treatment as Usual Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.
Overall Study STARTED	26	24
Overall Study COMPLETED	24	20
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Motivational Enhancement Therapy for Antidepressants n=26 Participants Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.	Treatment as Usual n=24 Participants Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.	Total n=50 Participants Total of all reporting groups
Age, Continuous	40.2 years STANDARD_DEVIATION 10.8 • n=5 Participants	41 years STANDARD_DEVIATION 13 • n=7 Participants	40.6 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	24 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured immediately post-treatment and at Months 2 and 5 months follow-ups

Population: We used an ITT with LOCF. These figures represent outcomes at 5 months.

Medication container caps (MEMS) recorded each instance where the antidepressant medication container was opened. An adherence index was derived the represented the percentage of days, within the medication period, where the container was opened.

Outcome measures

Outcome measures
Measure	Motivational Enhancement Therapy for Antidepressants n=26 Participants	Treatment as Usual n=24 Participants
Medication Adherence, as Measured by Electronic Pill Container	58.76 Percentage of Days Standard Error 6.59	34.7 Percentage of Days Standard Error 6.87

SECONDARY outcome

Timeframe: Measured at Month 5

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Month 5

The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. Higher total scores indicate more severe depressive symptoms.

Outcome measures

Outcome measures
Measure	Motivational Enhancement Therapy for Antidepressants n=26 Participants	Treatment as Usual n=24 Participants
Beck Depression Inventory-II (BDI-II)	16.75 units on a scale Standard Error 2.70	23.03 units on a scale Standard Error 2.81

SECONDARY outcome

Timeframe: Measured at Month 5

Outcome measures

Outcome data not reported

Adverse Events

Motivational Enhancement Therapy for Antidepressants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alejandro Interian, Principal Investigator

VA New Jersey Healthcare System

Phone: 908-647-0180

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place