Cognitive Behavioral Stress Management for HIV+ Drug Abusers
Primary Purpose
HIV/AIDS, Drug Abuse, Alcohol Abuse
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Cognitive Behavioral Stress Management
Sponsored by
About this trial
This is an interventional treatment trial for HIV/AIDS focused on measuring HIV, Medication Adherence, Stress Management, CD4/Viral Loads, Cognitive Behavioral Treatment
Eligibility Criteria
- >18, but <60 years of age
- fluency in spoken English which is required to complete assessments and to participate in the intervention groups;
- acknowledgement of HIV seropositivity and willingness to be tested to confirm this serostatus;
- currently not cognitively impaired since cognitive impairment may compromise the ability to comprehend and participate in the assessment and intervention;
- currently not showing symptoms of a major psychiatric disorder/ including psychosis, or a high risk for suicidality since these conditions might compromise ability to comprehend and participate in the assessment and intervention; and
- classification as a "Recovering Drug Abusers" (RDAs; 30 days free of substances, 1-36 months recovery from alcohol and other drugs).
Sites / Locations
Outcomes
Primary Outcome Measures
To evaluate if CBSM-RDA produces therapeutic improvement in distress and quality of life indices to a greater extent than HPC.
SPECIFIC AIM 2: To evaluate if CBSM-RDA reduces drug abuse relapse to a greater extent than HPC.
SPECIFIC AIM 3: To evaluate if CBSM-RDA reduces unsafe sex to a greater extent than HPC.
SPECIFIC AIM 4: To evaluate if CBSM-RDA enhances CART adherence to a greater extent than HPC.
SPECIFIC AIM 5: To evaluate if CBSM-RDA enhances health status to a greater extent than HPC.
SPECIFIC AIM 6: To evaluate the extent to which key variables may mediate the relationships between our intervention and endpoints.
SPECIFIC AIM 7: To evaluate the extent to which key variables moderate the relationships between our intervention and endpoints.
Secondary Outcome Measures
Full Information
NCT ID
NCT00722644
First Posted
July 23, 2008
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00722644
Brief Title
Cognitive Behavioral Stress Management for HIV+ Drug Abusers
Official Title
Cognitive Behavioral Treatment of HIV+ Drug Abusers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
The primary purpose of this 5-year study is to determine whether a Cognitive Behavioral Stress Management (CBSM) intervention, demonstrated to be effective in reducing distress, enhancing coping, and maintaining health among HIV+ non-drug abusers (see Schneiderman and Antoni, 2000), can be effectively adapted for our target population of culturally diverse, HIV+, low-income "Recovering Drug Abusers" (RDAs). Since the late 1980s, members of our research team (i.e., Schneiderman, Antoni, Klimas, Fletcher) have been developing, refining and evaluating the effects of CBSM among HIV+ Men who have Sex with Men (MSM). In the early/mid 90s, we began to adapt and evaluate the effects of CBSM in other non-drug abusing subgroups that were emerging with increasing levels of HIV seroprevalence (e.g., pregnant women, African American and Hispanic men and women). After accumulating considerable support for the effectiveness of CBSM in these subgroups in the late 90s, our research team (i.e., Malow, Schneiderman, Antoni, Klimas, Page) turned its attention to developing the CBSM for one of the most neglected and understudied populations affected by the HIV/AIDS epidemic in this country: "inner city" minority drug abusers. With supplemental funding on two NIH grants to conduct formative stage1 pilot research, our project team has been able to develop and document the feasibility and potential promise of the CBSM approach adapted/translated for RDAs (CBSM-RDA). This application proposes to take the next logical step in continuing this work: conducting a 3, 6, 8, 10, and 12 month follow-up outcome study comparing CBSM-RDA with a matched attention, time and interest value Health Promotion Comparison (HPC) condition, in 225 male and 225 female HIV+ RDAs with respect to key biopsychosocial health endpoints: distress (i.e., depressive symptoms, and mood state), quality of life, drug abuse relapse, unsafe sex, Combination Antiretroviral Therapy (CART) medication adherence and health status indicators (e.g., Viral Load, CD4 count, physical symptoms).
Detailed Description
The primary purpose of this proposed 5-year study is to determine whether a Cognitive Behavioral Stress Management (CBSM) intervention, demonstrated to be effective in reducing distress, enhancing coping, and maintaining health among HIV+ non-drug abusers (see Schneiderman and Antoni, 2000), can be effectively adapted for our target population of culturally diverse, HIV+, low-income "Recovering Drug Abusers" (RDAs). Since the late 1980s, members of our research team (i.e., Schneiderman, Antoni, Klimas, Fletcher) have been developing, refining and evaluating the effects of CBSM among HIV+ Men who have Sex with Men (MSM). In the early/mid 90s, we began to adapt and evaluate the effects of CBSM in other non-drug abusing subgroups that were emerging with increasing levels of HIV seroprevalence (e.g., pregnant women, African American and Hispanic men and women). After accumulating considerable support for the effectiveness of CBSM in these subgroups in the late 90s, our research team (i.e., Malow, Schneiderman, Antoni, Klimas, Page) turned its attention to developing the CBSM for one of the most neglected and understudied populations affected by the HIV/AIDS epidemic in this country: "inner city" minority drug abusers. With supplemental funding on two NIH grants to conduct formative stage1 pilot research, our project team has been able to develop and document the feasibility and potential promise of the CBSM approach adapted/translated for RDAs (CBSM-RDA). This application proposes to take the next logical step in continuing this work: conducting a 3, 6, 8, 10, and 12 month follow-up outcome study comparing CBSM-RDA with a matched attention, time and interest value Health Promotion Comparison (HPC) condition, in 225 male and 225 female HIV+ RDAs with respect to key biopsychosocial health endpoints: distress (i.e., depressive symptoms, and mood state), quality of life, drug abuse relapse, unsafe sex, Combination Antiretroviral Therapy (CART) medication adherence and health status indicators (e.g., Viral Load, CD4 count, physical symptoms).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Drug Abuse, Alcohol Abuse
Keywords
HIV, Medication Adherence, Stress Management, CD4/Viral Loads, Cognitive Behavioral Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
450 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Stress Management
Primary Outcome Measure Information:
Title
To evaluate if CBSM-RDA produces therapeutic improvement in distress and quality of life indices to a greater extent than HPC.
Title
SPECIFIC AIM 2: To evaluate if CBSM-RDA reduces drug abuse relapse to a greater extent than HPC.
Title
SPECIFIC AIM 3: To evaluate if CBSM-RDA reduces unsafe sex to a greater extent than HPC.
Title
SPECIFIC AIM 4: To evaluate if CBSM-RDA enhances CART adherence to a greater extent than HPC.
Title
SPECIFIC AIM 5: To evaluate if CBSM-RDA enhances health status to a greater extent than HPC.
Title
SPECIFIC AIM 6: To evaluate the extent to which key variables may mediate the relationships between our intervention and endpoints.
Title
SPECIFIC AIM 7: To evaluate the extent to which key variables moderate the relationships between our intervention and endpoints.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
>18, but <60 years of age
fluency in spoken English which is required to complete assessments and to participate in the intervention groups;
acknowledgement of HIV seropositivity and willingness to be tested to confirm this serostatus;
currently not cognitively impaired since cognitive impairment may compromise the ability to comprehend and participate in the assessment and intervention;
currently not showing symptoms of a major psychiatric disorder/ including psychosis, or a high risk for suicidality since these conditions might compromise ability to comprehend and participate in the assessment and intervention; and
classification as a "Recovering Drug Abusers" (RDAs; 30 days free of substances, 1-36 months recovery from alcohol and other drugs).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert M. Malow, PhD
Organizational Affiliation
Florida International University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Cognitive Behavioral Stress Management for HIV+ Drug Abusers
We'll reach out to this number within 24 hrs