Depression and ART Adherence in HIV+ Latinos
|ClinicalTrials.gov Identifier: NCT01411839|
Recruitment Status : Completed
First Posted : August 8, 2011
Results First Posted : March 19, 2018
Last Update Posted : March 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Depressive Symptoms HIV Infections||Behavioral: Cognitive-Behavioral Therapy (CBT-AD)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Addressing Depression and ART Adherence in HIV+ Latinos on the U.S.-Mexico Border|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||January 2012|
Experimental: Cognitive-Behavioral Therapy (CBT-AD)
This arm type is a cognitive-behavioral therapy program intervention for issues of medication adherence and depression. The intervention is a therapy program intervention involves 10-weekly or biweekly sessions, with 2 booster session, and focused on psychoeducation, behavioral activation, cognitive restructuring, and problem-solving. A letter was sent to their medical provider indicating that mild symptoms of depression were detected and that they were enrolled in this intervention, but no details were provided regarding their assignment to one of two conditions/arms.
Behavioral: Cognitive-Behavioral Therapy (CBT-AD)
CBT-AD is a therapy program intervention that uses one-on-one and face-to-face patient-therapist sessions.
Other Name: CBT-AD
No Intervention: Control-Standard Care
Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter was sent to their medical provider indicating that mild symptoms of depression were detected and that they were enrolled in this intervention, but no details were provided regarding their assignment to one of two conditions/arms. The participants in the control arm are followed and matched to a participant in the intervention arm.
- Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a [ Time Frame: MADRS and BDI-1a scores at 6 and 9-month follow-up ]
- Clinician-administered ratings are scored on the MADRS. The MADRS is a 10-item, past 7-day clinician administered scripted rating scale of depressive symptoms (each of the ten items is scored from 0-6, with total scores ranging from 0 to 60). The areas are: apparent and reported sadness, inner tension, reduced sleep/appetite, concentration difficulties, lassitude, inability to feel, pessimistic and suicidal thoughts. Higher scores indicate the presence of more depressive symptoms.
- Participant self-report ratings are scored on the BDI-1a. The BDI-1a is assessed at each time point using the revised Beck Depression Inventory-Ia (BDI-Ia), which consists of 21 items, each with a 4-point response scale anchored with descriptive statements. Scores can range from 0-63, and scores of 10 or higher are presumptive of mild depressive severity. The BDI scores presented were added up and higher scores indicate worse depression. The MADRS and BDI-Ia is scored a total units on the scale.
- Self-Report Adherence [ Time Frame: Self-reported adherence at 6 and 9-month follow-up ]Self-reported adherence was assessed with the visual analog scale (VAS). The VAS is a 10cm line that is shown to patients who then mark on the line (from 0 to 100% in 1cm intervals) how much medication they have taken. Higher scores indicate better adherence.
- MedSignals Electronic Pill-box for Adherence [ Time Frame: 6 and 9 month follow-up adherence scores ]The MedSignals electronic pill-box is a storage bin that allows participants to store medications. In the treatment condition, the pill-box provides audio commands to alarm participants that it is time to take their medication. The pill-box stores adherence data (time, number of openings). In the control condition, the pill-box does not alarm participants but serves in the same capacity otherwise. All data is uploaded electronically. Higher numbers indicate better adherence that correspond to pill-box openings corresponding to the designated time of taking their medication.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411839
|United States, Texas|
|Centro de Salud Familiar La Fe CARE Center|
|El Paso, Texas, United States, 79925|
|Principal Investigator:||Jane M Simoni, Ph.D.||University of Washington|