Intervention Targeting Substance Using Older Adults With HIV

NCT ID: NCT01305629

Last Updated: 2016-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2016-06-30

Brief Summary

The proposed study uses a randomized controlled experimental design to evaluate the efficacy of a brief intervention using spiritual self schema (3S+) counseling to simultaneously target HIV health outcomes, and substance use among alcohol and/or drug dependent HIV positive older adults (age 50+), relative to an attention control condition. Participants will be randomly assigned to receive either: (1) 12 sessions of 3S+ counseling, adapted for the present study to target both non-injection drug use, drinking, and HIV health; or (2) 12 sessions of education about HIV health and the associated with alcohol and drug use that will serve as an attention-control.

Conditions

HIV; Medication Adherence; Substance Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Condition

Twelve sessions of spiritual self schema counseling, adapted to target target medication adherence and substance use.

Group Type: EXPERIMENTAL

Spiritual Self-Schema Therapy

Intervention Type: BEHAVIORAL

The Spiritual Self Schema therapy (3S+) intervention will consist of a series of 12 one hour-long sessions delivered individually to participants over a four-month period. The 3S+ approach combines cognitive and behavioral therapy techniques with elements of non-theistic Buddhist philosophy to increase motivation for treatment adherence, alcohol and/or substance use reduction or abstinence and the prevention or reduction of HIV risk behaviors. 3S+ draws from self-regulation theory, self-schema theory, and self-discrepancy theory to assist participants in defining and perceiving their addict self, when their addict self is active, and its resulting negative affect state. 3S+ remediates the "addict" schema by proposing the construction of an alternate and competing schema: the "spiritual self." This spiritual self schema is compatible with HIV self-care, alcohol and drug use reduction or abstinence, adherence to treatment, and a compassionate life.

Education Condition

Eight sessions of education with content designed to mirror the information covered in the intervention condition.

Group Type: ACTIVE_COMPARATOR

Spiritual Self-Schema Therapy

Intervention Type: BEHAVIORAL

The Spiritual Self Schema therapy (3S+) intervention will consist of a series of 12 one hour-long sessions delivered individually to participants over a four-month period. The 3S+ approach combines cognitive and behavioral therapy techniques with elements of non-theistic Buddhist philosophy to increase motivation for treatment adherence, alcohol and/or substance use reduction or abstinence and the prevention or reduction of HIV risk behaviors. 3S+ draws from self-regulation theory, self-schema theory, and self-discrepancy theory to assist participants in defining and perceiving their addict self, when their addict self is active, and its resulting negative affect state. 3S+ remediates the "addict" schema by proposing the construction of an alternate and competing schema: the "spiritual self." This spiritual self schema is compatible with HIV self-care, alcohol and drug use reduction or abstinence, adherence to treatment, and a compassionate life.

Interventions

Spiritual Self-Schema Therapy

The Spiritual Self Schema therapy (3S+) intervention will consist of a series of 12 one hour-long sessions delivered individually to participants over a four-month period. The 3S+ approach combines cognitive and behavioral therapy techniques with elements of non-theistic Buddhist philosophy to increase motivation for treatment adherence, alcohol and/or substance use reduction or abstinence and the prevention or reduction of HIV risk behaviors. 3S+ draws from self-regulation theory, self-schema theory, and self-discrepancy theory to assist participants in defining and perceiving their addict self, when their addict self is active, and its resulting negative affect state. 3S+ remediates the "addict" schema by proposing the construction of an alternate and competing schema: the "spiritual self." This spiritual self schema is compatible with HIV self-care, alcohol and drug use reduction or abstinence, adherence to treatment, and a compassionate life.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• HIV+ (provide HIV medication bottle with name on it)
• Age 50 or older (provide picture ID with DOB at baseline)
• Report current alcohol/drug dependence (AUDIT score of 8 or DAST-10 score of 4 on screener; C-DIS at baseline)
• On a prescribed HAART medication regimen and reports sub-optimal adherence (self-report missed at least 3 days in last 30 at 1 pill/day that is 90%)
• Communicate with staff and complete a survey in English or Spanish (English only for the pilot)

Exclusion Criteria

• Current intravenous drug use (self-report at screener and baseline)
• Currently in a methadone drug treatment program (screener self-report)
• Unstable, serious psychiatric symptoms (SCID-Psych at baseline)
• Currently suicidal/homicidal (SCID-Psych at baseline)
• Gross cognitive impairment (Mini-Mental at baseline)
• Current enrollment in alcohol/drug treatment or HIV study (screener self-report)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fordham University

OTHER

Sponsor Role: collaborator

Hunter College of City University of New York

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey T. Parsons

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey T. Parsons, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Hunter College, CUNY

Locations

Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY

New York, New York, United States

Countries

United States

Other Identifiers

R01DA029567-01

Identifier Type: NIH

Identifier Source: org_study_id

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