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Trial record 54 of 692 for:    BDI | "Depression"

Depression and ART Adherence in HIV+ Latinos

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ClinicalTrials.gov Identifier: NCT01411839
Recruitment Status : Completed
First Posted : August 8, 2011
Results First Posted : March 19, 2018
Last Update Posted : March 19, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of Texas
Information provided by (Responsible Party):
Jane Simoni, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Depressive Symptoms
HIV Infections
Intervention Behavioral: Cognitive-Behavioral Therapy (CBT-AD)
Enrollment 40

Recruitment Details Data were collected in a two-stage process from 10/21/2009 – 8/31/2011 at a publicly-funded community health clinic in El Paso, TX, on the U.S.-Mexico border.
Pre-assignment Details Eligible participants were randomly assigned to the intervention or treatment as usual (TAU) control condition, both enhanced with the notification letter to provider. An external statistician had used a computerized random number generator to select random permuted blocks of four.
Arm/Group Title Cognitive-Behavioral Therapy (CBT-AD) Control-Standard Care
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CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.

Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions

Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
Period Title: Overall Study
Started 20 20
Completed 16 17
Not Completed 4 3
Reason Not Completed
Lost to Follow-up             4             3
Arm/Group Title Cognitive-Behavioral Therapy (CBT-AD) Control-Standard Care Total
Hide Arm/Group Description

CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.

Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions

Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm. Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
40
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
47.3  (10.7) 44.8  (10.7) 46  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
5
  25.0%
6
  30.0%
11
  27.5%
Male
15
  75.0%
14
  70.0%
29
  72.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Hispanic or Latino
20
 100.0%
20
 100.0%
40
 100.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Beck Depression Inventory 1a   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 20 participants 40 participants
22  (9.2) 16.8  (6.3) 19.4  (8.2)
[1]
Measure Description: Self-reported depressive symptoms were 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.
Visual Analog Scale 30-day Adherence   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent of doses taken
Number Analyzed 20 participants 20 participants 40 participants
84.4  (24.4) 90.6  (11.1) 87.2  (19.5)
[1]
Measure Description: Self-reported adherence was assessed with the visual analog scale. This 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.
Electronic Drug Adherence Monitoring   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent Adherence
Number Analyzed 20 participants 20 participants 40 participants
43.2  (43.5) 55.6  (47.6) 49.4  (40.6)
[1]
Measure Description: 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 the designated time of taking their medication.
Montgomery-Asberg Depression Rating Scale (MADRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 20 participants 40 participants
25.1  (9.7) 22.1  (9.8) 23.6  (9.7)
[1]
Measure Description: The MADRS is a 10-item 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 scale was developed to capture current depressive symptoms within the past seven days. The areas covered include: apparent and reported sadness, inner tension, reduced sleep and appetite, concentration difficulties, lassitude, inability to feel, pessimistic and suicidal thoughts. Higher scores indicate the presence of more depressive symptoms.
1.Primary Outcome
Title Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a
Hide Description
  1. 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.
  2. 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.
Time Frame MADRS and BDI-1a scores at 6 and 9-month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive-Behavioral Therapy (CBT-AD) Control-Standard Care
Hide Arm/Group Description:

CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.

Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions

Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: Units on a scale
MADRS at 6-month follow-up 17.8  (12.2) 19.2  (11.2)
MADRS at 9-month follow-up 19.7  (12.7) 17.7  (12.9)
BDI-1a at 6-month follow-up 15.0  (7.4) 11.8  (7.0)
BDI-1a at 9-month follow-up 14.2  (7.0) 13.5  (9.0)
2.Secondary Outcome
Title Self-Report Adherence
Hide Description 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.
Time Frame Self-reported adherence at 6 and 9-month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive-Behavioral Therapy (CBT-AD) Control-Standard Care
Hide Arm/Group Description:

CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.

Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions

Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: Percent of all doses of medication taken
Self-report adherence at 6-month follow-up 92.6  (9.4) 86  (14.7)
Self-report adherence at 9-month follow-up 93.5  (9.0) 91.9  (7.7)
3.Secondary Outcome
Title MedSignals Electronic Pill-box for Adherence
Hide Description 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.
Time Frame 6 and 9 month follow-up adherence scores
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive-Behavioral Therapy (CBT-AD) Control-Standard Care
Hide Arm/Group Description:

CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.

Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions

Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: Percent adherence
Electronic Adherence at 6-month Follow-Up 45.8  (47.8) 28.8  (31)
Electronic Adherence at 9-month Follow-Up 31.1  (44.9) 20.0  (31.5)
Time Frame 1 Year, 9 Months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cognitive-Behavioral Therapy (CBT-AD) Control-Standard Care
Hide Arm/Group Description

CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.

Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions

Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
All-Cause Mortality
Cognitive-Behavioral Therapy (CBT-AD) Control-Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cognitive-Behavioral Therapy (CBT-AD) Control-Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cognitive-Behavioral Therapy (CBT-AD) Control-Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. John A. Sauceda
Organization: University of California, San Francisco
Phone: 415-460-6045
Responsible Party: Jane Simoni, University of Washington
ClinicalTrials.gov Identifier: NCT01411839     History of Changes
Other Study ID Numbers: 35279
R34MH084674 ( U.S. NIH Grant/Contract )
First Submitted: July 25, 2011
First Posted: August 8, 2011
Results First Submitted: November 10, 2017
Results First Posted: March 19, 2018
Last Update Posted: March 19, 2018