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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
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

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 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers
  1. >18, but <60 years of age
  2. fluency in spoken English which is required to complete assessments and to participate in the intervention groups;
  3. acknowledgement of HIV seropositivity and willingness to be tested to confirm this serostatus;
  4. currently not cognitively impaired since cognitive impairment may compromise the ability to comprehend and participate in the assessment and intervention;
  5. 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
  6. 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

    First Posted
    July 23, 2008
    Last Updated
    January 10, 2017
    Sponsor
    National Institute on Drug Abuse (NIDA)
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    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

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    Cognitive Behavioral Stress Management for HIV+ Drug Abusers

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