Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1



Status:Completed
Conditions:Depression, Depression, Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:1/3/2018
Start Date:February 2005
End Date:July 2009

Use our guide to learn which trials are right for you!

CBT for Depression & Adherence in HIV Methadone Patients

Patients with HIV, depression, and opioid-dependence are at high risk for poor health
outcomes. This is a two-arm randomized controlled trial of cognitive-behavioral therapy for
depression and HIV medication adherence in patients with opioid dependence who are receiving
methadone maintenance treatment. The project is based on our pilot work with close attention
to NIDA guidelines for a staged approach to treatment development and testing (Rounsaville et
al., 2001).

Depression is highly comorbid with both HIV infection and with opioid dependence. Depression
and substance abuse are both associated with poor adherence to antiretroviral medications.
Patients with HIV, depression, and opioid dependence are at high risk for poor health
outcomes. Cognitive-behavioral therapy is the most widely studied and efficacious
psychosocial intervention for depression; and research by the PI and others has shown that
cognitive-behavioral interventions have been successful in promoting adherence to HIV
medications.

Symptoms of depression (i.e. low motivation, poor concentration, loss of interest, sad mood,
suicidal ideation) that occur in the context of substance abuse or dependence can interfere
with self-care behaviors necessary for maintaining HIV care, as well as interfere with
potential benefit from an intervention that focuses on adherence alone. We hypothesize that
teaching skills to cope with depression will improve the outcome from an adherence
intervention to promote healthier living with HIV, in HIV+ opioid dependent individuals in
methadone maintenance treatment.

Overview of Research Plan. Patients who are HIV positive and who are receiving methadone
maintenance for opioid dependence will be randomized to treatment with either: (1) CBT, a
combination of CBT for depression and HIV medication adherence, including a single session
intervention for HIV medication adherence (Life-Steps, Safren et al., 2001) in conjunction
with physician feedback regarding baseline study assessments or (2) the single session
intervention for HIV medication adherence (Life-Steps, Safren et al., 2001) in conjunction
with physician feedback regarding baseline study assessments. Participants will be followed
for one-year post-randomization.

Inclusion Criteria:

- HIV seropositive

- Currently enrolled in methadone maintenance treatment for at least one month

- Current major or subsyndromal depression (subsyndromal depression is defined by major
depression that does not meet full diagnostic criteria but with a clinical global
impression of severity (CGI-S) of 2 (mildly ill))

- Is prescribed antiretroviral therapy for HIV and therefore under the care of a primary
care provider.

- Between the ages of 18 and 65.

Exclusion Criteria:

- Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania),
or other Axis I psychiatric disorders (other than depression) that would interfere
with the ability to participate (i.e. CGI-S >6)

- Unable or unwilling to provide informed consent.

- Currently in cognitive behavioral therapy for depression.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials