Healthy Activities for Prize Incentives

NCT ID: NCT00717444

Last Updated: 2018-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2013-05-31

Brief Summary

In this Stage 1 therapy development project, we plan to develop, formalize, and derive effect size estimates of a contingency management (CM) therapy that focuses on improving health, especially as related to increasing low intensity physical activities, such as walking, resistance training, and stretching. The Healthy Activities for Prize Incentives (HAPI) intervention will be targeted toward and tested within HIV-positive substance abusers who attend HIV drop-in centers. After initial therapy development in a Stage 1a pilot project with 9 patients, the therapy manuals and materials will be adapted and refined. In a Stage 1b controlled trial, we will recruit and randomize 70 substance abusing HIV-positive patients to (a) HAPI plus 12-step facilitation therapy or (b) contingency management for abstinence plus 12-step facilitation therapy. Each intervention will consist of one weekly individual therapy session for 16 weeks. All participants will provide urine and breath specimens twice weekly that will be tested for opioids, cocaine, methamphetamine, marijuana and alcohol. Patients in both conditions will earn the chance to win prizes for submitting drug-negative specimens, and those randomized to the HAPI condition will also earn the chance to win prizes for engaging in healthy activities. Physical activity levels, drug use, psychological symptoms, and subjective and objective indicators of health (body mass index, waist circumference, blood pressure, viral load) will be measured pre-treatment and at months 2 and 4 (post-treatment), as well as at a 7-month (3 months after treatment) follow-up evaluation. Compared to those receiving 12-step facilitation with contingency management for abstinence, we expect that those in the HAPI condition will participate in more physical activities, decrease drug use to a greater extent, evidence reduced depression, and show trends toward improvements in health indices. If effect sizes in at least the small to medium range are noted across all domains, we will consider the therapy appropriate for further evaluation in a Stage 2 therapy development study.

Conditions

Substance Abuse; HIV Infections

Keywords

Substance Abuse; HIV; Contingency Management; Physical Activity

Study Design

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

Study Groups

1

contingency management for abstinence plus 12-step facilitation therapy and contingency management for completing healthy activities

Group Type: EXPERIMENTAL

contingency management

Intervention Type: BEHAVIORAL

contingency management for abstinence plus 12-step facilitation therapy and contingency management for completing healthy activities

prizes awarded for target behaviors

2

contingency management for abstinence plus 12-step facilitation therapy

Group Type: EXPERIMENTAL

contingency management

Intervention Type: BEHAVIORAL

contingency management for abstinence plus 12-step facilitation therapy

prizes awarded for target behaviors

Interventions

contingency management

contingency management for abstinence plus 12-step facilitation therapy

prizes awarded for target behaviors

Intervention Type: BEHAVIORAL

contingency management

contingency management for abstinence plus 12-step facilitation therapy and contingency management for completing healthy activities

prizes awarded for target behaviors

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• HIV+ and a member of Connections
• Age 18-65 years
• English speaking
• Past-year DSM-IV diagnosis of opioid, cocaine, methamphetamine, alcohol, or marijuana abuse or dependence
• Written permission from one's primary care or infectious disease physician to participate in the study and an exercise program
• Plans to reside in the local area for the next 8 months and
• Willing to sign informed consent

Exclusion Criteria

• Inability to comprehend the study as assessed by the Informed Consent Quiz and Mini-Mental Status Exam (MMSE)
• Severely disruptive behavior
• In recovery for pathological gambling (due to potential similarity between the contingency management procedure and gambling)
• Serious uncontrolled psychiatric disorder other than substance use disorders that require inpatient hospitalization (e.g., active bipolar disorder, psychosis, suicidal)
• History of myocardial infarction, stroke, unstable angina, coronary artery bypass grafting, angioplasty/stent, uncontrolled arrhythmia, or hyperthyroidism in the past 6 months as reported by patient or physician
• Blood pressure >165/95 mmHg and
• Grossly abnormal findings on indices of physical functioning (>2 SDs above means for sedentary age/gender norms according to ACSM, 2006)
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nancy M Petry, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

Connections, Inc.

Hartford, Connecticut, United States

Countries

United States

Other Identifiers

1R01DA022739-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

08-251-2

Identifier Type: -

Identifier Source: org_study_id