Trial Outcomes & Findings for Effects of Adding Motivational Interviewing to Antidepressant Treatment for Hispanic Adults With Depression (NCT NCT00564278)
NCT ID: NCT00564278
Last Updated: 2021-05-19
Results Overview
A continuous measure of the total number of days in treatment, based on visit attendance. At each kept visit, patients will be credited as having been in treatment for the number of days since their last scheduled visit. For example, patients attending sessions on weeks 0, 1, and 12 would have been in treatment for 35 days (7 \[week 0 to week 1\] + 28 \[week 8 to week 12\]).
COMPLETED
NA
217 participants
Measured at Months 3 and 9
2021-05-19
Participant Flow
The recruitment period extended from June 3, 2008 to Aug 14, 2013. Advertising was placed in local newspapers recruiting Hispanic adults to the trial, which took place in the Hispanic Treatment Program at the Psychiatric Institute, a research and clinical institute in Upper Manhattan affiliated with Columbia University.
Of N=109 patients enrolled in SADT, 12 were pre-treatment drops (signed consent but did not return for a medication visit) and N=97 came to 1+ medication visit. Of N=108 patients enrolled in MADT, 10 were pre-treatment drops (signed consent but did not return for a medication visit) and N=98 participated in at least one medication visit.
Participant milestones
| Measure |
Standard Antidepressant Therapy
As per study criteria, the N=97 sample is our sample for data analysis. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline Hamilton Depression Scale-17 score of 16 or greater. Mean age was 43.41 (SD = 13.2).
|
Motivational Antidepressant Therapy
As per study criteria, the N=98 sample is our sample for data analysis. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline Hamilton Depression Scale-17 score of 16 or greater. Mean age was 44.1 (SD = 12.3).
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
98
|
|
Overall Study
COMPLETED
|
50
|
56
|
|
Overall Study
NOT COMPLETED
|
47
|
42
|
Reasons for withdrawal
| Measure |
Standard Antidepressant Therapy
As per study criteria, the N=97 sample is our sample for data analysis. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline Hamilton Depression Scale-17 score of 16 or greater. Mean age was 43.41 (SD = 13.2).
|
Motivational Antidepressant Therapy
As per study criteria, the N=98 sample is our sample for data analysis. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline Hamilton Depression Scale-17 score of 16 or greater. Mean age was 44.1 (SD = 12.3).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
35
|
33
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
11
|
7
|
Baseline Characteristics
Effects of Adding Motivational Interviewing to Antidepressant Treatment for Hispanic Adults With Depression
Baseline characteristics by cohort
| Measure |
Standard Medication Therapy
n=97 Participants
N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater. Mean age was 43.4 with SD=13.2.
|
Motivational Pharmacotherapy
n=98 Participants
N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater. Mean age was 44.1 with SD=12.3.
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
93 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
44.1 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
43.8 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
97 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
97 participants
n=5 Participants
|
98 participants
n=7 Participants
|
195 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Months 3 and 9Population: Patients who signed consent and attended at least one medication visit.
A continuous measure of the total number of days in treatment, based on visit attendance. At each kept visit, patients will be credited as having been in treatment for the number of days since their last scheduled visit. For example, patients attending sessions on weeks 0, 1, and 12 would have been in treatment for 35 days (7 \[week 0 to week 1\] + 28 \[week 8 to week 12\]).
Outcome measures
| Measure |
Standard Antidepressant Therapy
n=97 Participants
N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
|
Motivational Antidepressant Therapy
n=98 Participants
N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
|
|---|---|---|
|
Number of Days in ADT (Retention)
Days in txt at 9 months
|
148.7 Days in treatment
Standard Deviation 99.3
|
164.1 Days in treatment
Standard Deviation 89.2
|
|
Number of Days in ADT (Retention)
Days in txt at 3 months
|
59.5 Days in treatment
Standard Deviation 30.65
|
65.5 Days in treatment
Standard Deviation 24.6
|
PRIMARY outcome
Timeframe: HAMD-17 assessed at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.Population: All patients enrolled in both arms with available data at assessment time points.
Depressive symptoms were assessed using the 17-item standard clinician-administered version of the Hamilton Depression Scale (HAMD-17). We analyzed the HAMD-17 score, calculated as the sum of the individual items and ranging from 0 to 35 with higher numbers indicating more symptoms. HAMD-17 was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the HAMD-17 over 36 weeks using repeated measures.
Outcome measures
| Measure |
Standard Antidepressant Therapy
n=97 Participants
N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
|
Motivational Antidepressant Therapy
n=98 Participants
N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
|
|---|---|---|
|
Mean of Depressive Symptoms Over 36-week Follow-up Using Hamilton Depression Scale -17-item Version (Symptoms)
|
12.08 units on a scale ranging from 0 to 35
Standard Deviation 7.17
|
11.71 units on a scale ranging from 0 to 35
Standard Deviation 7.31
|
PRIMARY outcome
Timeframe: SDS at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.Population: Patients with available data at assessment time points.
Psychosocial functioning was assessed using the Sheehan Disability Scale (SDS), a self-report instrument composed of three visual analog subscales assessing degree of disruption caused by symptoms in three domains: work, social/leisure activities, and family/home life. We analyzed the 3 subscale scores for the 3 domains separately which ranged from 0 to 10 with higher scores indicating worse functioning. The SDS was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the SDS over 36 weeks using repeated measures.
Outcome measures
| Measure |
Standard Antidepressant Therapy
n=97 Participants
N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
|
Motivational Antidepressant Therapy
n=98 Participants
N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
|
|---|---|---|
|
Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment)
Work
|
4.36 Units on a scale ranging from 0-10
Standard Deviation 3.44
|
4.93 Units on a scale ranging from 0-10
Standard Deviation 3.41
|
|
Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment)
Social/leisure
|
4.87 Units on a scale ranging from 0-10
Standard Deviation 3.29
|
5.44 Units on a scale ranging from 0-10
Standard Deviation 3.27
|
|
Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment)
Family/home life
|
4.55 Units on a scale ranging from 0-10
Standard Deviation 3.14
|
5.05 Units on a scale ranging from 0-10
Standard Deviation 3.23
|
PRIMARY outcome
Timeframe: QLESQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.Population: Patients with available data at assessment time points.
Quality of life was assessed using the 16-item Short Form of the Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ), a self-reported measure of quality of life in 8 domains that is sensitive to depressive symptom severity and treatment response. We analyzed the QLESQ total score as a percentage of the maximum possible score (ranging from 0-100) to facilitate comparisons across areas of functioning. It was calculated as such: % Max = (Raw score - minimum possible score) / (maximum possible score-minimum possible score) where raw score is the sum of the first 14 items. Higher numbers indicate better quality of life, greater enjoyment, and satisfaction. The QLESQ was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the QLESQ over 36 weeks using repeated measures.
Outcome measures
| Measure |
Standard Antidepressant Therapy
n=97 Participants
N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
|
Motivational Antidepressant Therapy
n=98 Participants
N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
|
|---|---|---|
|
Mean Perceived Quality of Life Over 36-week Follow-up Using Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
|
50.05 percentage of maximum possible score
Standard Deviation 18.59
|
48.92 percentage of maximum possible score
Standard Deviation 19.50
|
SECONDARY outcome
Timeframe: CSQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.Population: Patients with available data at assessment time points.
Patient satisfaction was assessed using the 8-item Client Satisfaction Questionnaire (CSQ) which assesses patients' satisfaction with the services received. CSQ total score ranges from 8-32 with higher scores indicating greater satisfaction. The CSQ was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the CSQ over 36 weeks using repeated measures.
Outcome measures
| Measure |
Standard Antidepressant Therapy
n=97 Participants
N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
|
Motivational Antidepressant Therapy
n=98 Participants
N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
|
|---|---|---|
|
Mean Patient Satisfaction Over 36-week Follow-up Using Client Satisfaction Questionnaire (CSQ)
|
27.59 units on a scale ranging from 8 to 32
Standard Deviation 3.38
|
27.41 units on a scale ranging from 8 to 32
Standard Deviation 3.39
|
SECONDARY outcome
Timeframe: Measured at each visit, up to 36 weeksPopulation: All patients in both arms
We used the Composite Adherence Score (CAS) described in our grant application to calculate medication adherence levels from all data sources (electronic caps \[eCaps\], pill count, self-report) and compare these across arms. Calculated via a statistically calibrated algorithm, the CAS relied first on eCaps data, secondarily on pill count, and the adherence questionnaire if eCaps data was missing due to an eCap malfunction. We calculated the number of the days the patient was fully adherent, number of days of partial adherence (e.g., opened the eCap fewer times than prescribed), or number of days of nonadherence when they did not take any prescribed pills. Patients who dropped out of the study and provided no further follow-up data were considered nonadherent for the remainder of the study period. We calculated the therapy-adherent period as a proportion of the total intended treatment period or proportion of days of full adherence, # of fully adherent days / # of days in treatment.
Outcome measures
| Measure |
Standard Antidepressant Therapy
n=97 Participants
N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
|
Motivational Antidepressant Therapy
n=98 Participants
N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
|
|---|---|---|
|
Proportion of Fully Adherent Days
|
0.47 Proportion of Fully Adherent days
Standard Deviation 0.34
|
0.56 Proportion of Fully Adherent days
Standard Deviation 0.32
|
Adverse Events
Standard Antidepressant Therapy
Motivational Antidepressant Therapy
Serious adverse events
| Measure |
Standard Antidepressant Therapy
n=97 participants at risk
Participants will receive standard antidepressant therapy. Standard antidepressant therapy (SADT): Treatment with medication will follow the Texas Medication Algorithm (TMA) for Depression. Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR), bupropion SR (Wellbutrin SR), duloxetine (Cymbalta), nortriptyline (Pamelor), and mirtazapine (Remeron).
|
Motivational Antidepressant Therapy
n=98 participants at risk
Participants will receive motivational antidepressant therapy. Motivational antidepressant therapy (MADT): The same medication treatment for depression will be offered as in the SADT arm and supplemented with techniques from motivational interviewing.
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
1.0%
1/97 • Number of events 1 • Time frame was duration of study: maximum of 36 weeks.
|
0.00%
0/98 • Time frame was duration of study: maximum of 36 weeks.
|
|
Psychiatric disorders
Manic episode
|
0.00%
0/97 • Time frame was duration of study: maximum of 36 weeks.
|
2.0%
2/98 • Number of events 2 • Time frame was duration of study: maximum of 36 weeks.
|
Other adverse events
| Measure |
Standard Antidepressant Therapy
n=97 participants at risk
Participants will receive standard antidepressant therapy. Standard antidepressant therapy (SADT): Treatment with medication will follow the Texas Medication Algorithm (TMA) for Depression. Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR), bupropion SR (Wellbutrin SR), duloxetine (Cymbalta), nortriptyline (Pamelor), and mirtazapine (Remeron).
|
Motivational Antidepressant Therapy
n=98 participants at risk
Participants will receive motivational antidepressant therapy. Motivational antidepressant therapy (MADT): The same medication treatment for depression will be offered as in the SADT arm and supplemented with techniques from motivational interviewing.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Neck stiffness or soreness
|
3.1%
3/97 • Number of events 3 • Time frame was duration of study: maximum of 36 weeks.
|
5.1%
5/98 • Number of events 5 • Time frame was duration of study: maximum of 36 weeks.
|
Additional Information
Roberto Lewis-Fernandez, MD, Professor of Psychiatry CUMC - NYSPI
Columbia Univ Med Center and New York State Psychiatric Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place