Depressive Symptoms, HIV Infections
Conditions
Keywords
Depression, Latinos, Adherence, Cognitive-Behavioral Therapy, HIV/AIDS
Brief summary
The current HIV treatment adherence project was designed to adapt culturally and then pilot test an empirically supported cognitive-behavioral therapy program for adherence and symptoms of depression (CBT-AD)with HIV+ Latinos living on the U.S.-Mexico Border.
Detailed description
Additionally, the investigators will assess the feasibility and efficacy of a novel medication monitoring and reminder system (MedSignals®) in the form of an electronic pillbox with monitoring and reminding functions that is available in a Spanish-language version. Our hypotheses are grounded in a conceptual model proposing that the CBT-AD intervention will improve problem-solving ability and decrease depressive symptomatology, which will directly improve biomedical outcomes of HIV-1 RNA viral load and CD4 as well as indirectly improve biomedical outcomes through increased motivation, improved memory, and better medication adherence. Evaluating and implementing generalizable and sustainable mental health and adherence interventions such as the ones proposed are urgently needed in the region to improve HIV treatment outcomes and thwart the development and transmission of drug resistant virus.
Interventions
BEHAVIORALCognitive-Behavioral Therapy (CBT-AD)
CBT-AD is a therapy program intervention that uses one-on-one and face-to-face patient-therapist sessions.
Sponsors
National Institute of Mental Health (NIMH)
University of Texas
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV+ participants (a) currently receiving HIV care at La Fe CARE Center (study site); * 18 years of age or older; * Latino (i.e., self-identified as being of Mexican heritage); * English- or Spanish-speaking * capable of giving informed consent; * currently on a prescribed antiretroviral regimen; * suboptimally adherent (i.e., demonstrated either by a VL load taken in the last 12 months that is above the undetectable threshold of 50 mL copies or self-reporting a missed dose in the last two weeks); * exhibiting some depressive symptomatology (i.e., scoring on the Beck Depression Inventory-1A 10 or above), and (i) male or female (including transgender Female-to-Male and Male-To-Female.
Exclusion criteria
* actively psychotic or so cognitively impaired that they cannot participate, * so physically ill as to be unable to come to the clinic to participate in the intervention, OR * Report The use of crack, cocaine, heroin, OR methamphetamines to any extent in the past 40 days. * Those who are planning on being away from the area for any extended period during the study (as in the case of seasonal workers) or whom * have household members already enrolled in the study will also be excluded. We did choose to restrict study eligibility to individuals of Mexican descent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a | MADRS and BDI-1a scores at 6 and 9-month follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Report Adherence | 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 | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Cognitive-Behavioral Therapy (CBT-AD) 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 | 20 |
| 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 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. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 3 |
Baseline characteristics
| Characteristic | Control-Standard Care | Cognitive-Behavioral Therapy (CBT-AD) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Age, Continuous | 44.8 years STANDARD_DEVIATION 10.7 | 47.3 years STANDARD_DEVIATION 10.7 | 46 years STANDARD_DEVIATION 10.6 |
| Beck Depression Inventory 1a | 16.8 units on a scale STANDARD_DEVIATION 6.3 | 22 units on a scale STANDARD_DEVIATION 9.2 | 19.4 units on a scale STANDARD_DEVIATION 8.2 |
| Electronic Drug Adherence Monitoring | 55.6 Percent Adherence STANDARD_DEVIATION 47.6 | 43.2 Percent Adherence STANDARD_DEVIATION 43.5 | 49.4 Percent Adherence STANDARD_DEVIATION 40.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 20 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Montgomery-Asberg Depression Rating Scale (MADRS) | 22.1 units on a scale STANDARD_DEVIATION 9.8 | 25.1 units on a scale STANDARD_DEVIATION 9.7 | 23.6 units on a scale STANDARD_DEVIATION 9.7 |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 29 Participants |
| Visual Analog Scale 30-day Adherence | 90.6 Percent of doses taken STANDARD_DEVIATION 11.1 | 84.4 Percent of doses taken STANDARD_DEVIATION 24.4 | 87.2 Percent of doses taken STANDARD_DEVIATION 19.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive-Behavioral Therapy (CBT-AD) | Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a | MADRS at 6-month follow-up | 17.8 Units on a scale | Standard Deviation 12.2 |
| Cognitive-Behavioral Therapy (CBT-AD) | Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a | MADRS at 9-month follow-up | 19.7 Units on a scale | Standard Deviation 12.7 |
| Cognitive-Behavioral Therapy (CBT-AD) | Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a | BDI-1a at 6-month follow-up | 15.0 Units on a scale | Standard Deviation 7.4 |
| Cognitive-Behavioral Therapy (CBT-AD) | Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a | BDI-1a at 9-month follow-up | 14.2 Units on a scale | Standard Deviation 7 |
| Control-Standard Care | Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a | BDI-1a at 9-month follow-up | 13.5 Units on a scale | Standard Deviation 9 |
| Control-Standard Care | Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a | MADRS at 6-month follow-up | 19.2 Units on a scale | Standard Deviation 11.2 |
| Control-Standard Care | Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a | BDI-1a at 6-month follow-up | 11.8 Units on a scale | Standard Deviation 7 |
| Control-Standard Care | Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a | MADRS at 9-month follow-up | 17.7 Units on a scale | Standard Deviation 12.9 |
Secondary
MedSignals Electronic Pill-box for Adherence
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive-Behavioral Therapy (CBT-AD) | MedSignals Electronic Pill-box for Adherence | Electronic Adherence at 9-month Follow-Up | 31.1 Percent adherence | Standard Deviation 44.9 |
| Cognitive-Behavioral Therapy (CBT-AD) | MedSignals Electronic Pill-box for Adherence | Electronic Adherence at 6-month Follow-Up | 45.8 Percent adherence | Standard Deviation 47.8 |
| Control-Standard Care | MedSignals Electronic Pill-box for Adherence | Electronic Adherence at 6-month Follow-Up | 28.8 Percent adherence | Standard Deviation 31 |
| Control-Standard Care | MedSignals Electronic Pill-box for Adherence | Electronic Adherence at 9-month Follow-Up | 20.0 Percent adherence | Standard Deviation 31.5 |
Secondary
Self-Report Adherence
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive-Behavioral Therapy (CBT-AD) | Self-Report Adherence | Self-report adherence at 6-month follow-up | 92.6 Percent of all doses of medication taken | Standard Deviation 9.4 |
| Cognitive-Behavioral Therapy (CBT-AD) | Self-Report Adherence | Self-report adherence at 9-month follow-up | 93.5 Percent of all doses of medication taken | Standard Deviation 9 |
| Control-Standard Care | Self-Report Adherence | Self-report adherence at 6-month follow-up | 86 Percent of all doses of medication taken | Standard Deviation 14.7 |
| Control-Standard Care | Self-Report Adherence | Self-report adherence at 9-month follow-up | 91.9 Percent of all doses of medication taken | Standard Deviation 7.7 |