Motivational Antidepressant Therapy for Hispanics

NCT00564278 NA COMPLETED Results posted

This study will evaluate the effectiveness of adding motivational interviewing to antidepressant treatment for major depressive disorder in Hispanic adults.

Details

Lead sponsor	New York State Psychiatric Institute
Phase	NA
Status	COMPLETED
Enrolment	217
Start date	2008-02
Completion	2013-08

Conditions

• Depression

Interventions

• Standard antidepressant therapy (SADT)
• Motivational antidepressant therapy (MADT)

Primary outcomes

• Number of Days in ADT (Retention) — Measured at Months 3 and 9
  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 \[week 8 to week 12\]).
• Mean of Depressive Symptoms Over 36-week Follow-up Using Hamilton Depression Scale -17-item Version (Symptoms) — HAMD-17 assessed at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.
  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.
• Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment) — SDS at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.
  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.
• Mean Perceived Quality of Life Over 36-week Follow-up Using Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) — QLESQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.
  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.

Countries

United States