Behavioral Incentives to Increase Exercise in Cocaine Dependent Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Virginia Commonwealth University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01283191
First received: January 24, 2011
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

While physical activity has been associated with decreased craving and increased abstinence rates in smokers, few published studies have examined the effects of exercise on recovery from other drugs such as cocaine. One factor that has impeded such research has been low levels of patient compliance with exercise protocols. One robust strategy for promoting and maintaining behavior change is contingency management or Behavioral Incentives (BI). BI delivers incentives (prizes, vouchers) contingent upon target behaviors such as cocaine abstinence (Higgins et al., 1994); treatment attendance (Svikis et al., 1997) and other pro-social behaviors (Kirby et al., 1998). While the literature is replete with studies demonstrating the benefit of BI compared to control conditions (Stitzer & Petry, 2006), the translation of BI methods from research to clinical practice has met with some resistance. Contributing factors include philosophical differences (e.g., counselors feel extrinsic reinforcement undermines recovery) and practical barriers (e.g., monetary costs of incentives may be prohibitive). The latter concern was addressed by Petry (2005) who developed the "fish bowl" method, which uses escalating variable ratio procedures to reduce per patient costs of BI with similar effect sizes.

As a Stage 1 behavioral therapies development grant (Rounsaville et al., 2001), the primary aim of this research is to pilot test a BI intervention designed to promote regular physical activity in a sample of women receiving inpatient treatment for SUDs. The target behavior, physical activity, will be objectively defined as 30 minutes of observed treadmill walking at any intensity 3 days/week at Level 1, and 30 minutes of higher intensity physical activity that meets ACSM criteria for moderate exercise Level 2. Specifically, a pilot randomized clinical trial will compare rates of physical activity over a 6 week study period in a sample of N=50 women with Cocaine Dependence. All participants will complete baseline assessment, attend a 45-min Health and Fitness (HF) education group, followed by random assignment to either the experimental (BI) or control (C) groups, with equal daily access to on-site treadmills. Those randomized to BI, however, will also be eligible 3 days/week, to receive incentives for completing 30 minutes of treadmill walking.

Incentives will be dispensed using Petry Fish Bowl methods. Women assigned to the BI group will receive behavioral incentives (in the form of gift cards or prizes) for completing their scheduled exercise sessions (Level 1), and have the opportunity to earn "bonus" draws for meeting moderate intensity exercise criteria, as specified by ACSM (2007, revised) guidelines (Level 2). In Level 1, the number of tokens participants can draw from the gym bag (present study equivalent to "fishbowl") at each visit will be linked to exercise session attendance, with consistent attendance resulting in greater number of draws. In Level 2, the number of tokens a participant can draw from the gym bag will be linked to the intensity of the participant's exercise. Specifically, beginning in Week 2 of the study, participants will be re-evaluated for exercise capability. Those who pass the safety screen will be encouraged to exercise at a higher intensity, and those who do not will be re-evaluated until they obtain safety clearance. Once cleared, if the participant meets criteria for moderate exercise during her scheduled session, then she will be allotted a "bonus" draw (Level 2) for meeting Level 2 criteria, in addition to the escalating number of draws she would received for scheduled exercise session completion (Level 1).

Scheduled treadmill walking will be monitored and recorded for both BI and C group women. Follow-ups will occur at study midpoint and completion (3 and 6 weeks post-randomization, respectively), and at 4 weeks post-discharge. Assessments will focus on drug craving, mood, stress, motivation/self-efficacy, and physical health and well being. The investigators hypothesize that women in the BI group will complete more treadmill sessions and spend more time treadmill walking than those in the C group. As a Stage 1b therapy development RCT, study data will be used for effect size estimation in preparation for Stage 2 RCT. This dissertation proposal will provide benchmark data on the utility of BI for promoting physical activity. Further, it will promote exercise compliance, allowing scientists to better evaluate potential benefits of physical activity on treatment outcomes in women with SUDs.


Condition Intervention
Cocaine Dependence
Behavioral: Behavioral Incentives
Behavioral: Education Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Using Behavioral Incentives to Promote Exercise Compliance in Cocaine Dependent Women

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Time in core sessions [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Time (minutes) spent treadmill walking over 18 core sessions

  • Total time [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Total time (minutes) spent treadmill walking over the 6 week study period (core sessions + additional sessions)


Secondary Outcome Measures:
  • Higher intensity time [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Time (minutes) spent in higher intensity physical activity over 18 core sessions

  • Higher intensity total time [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Total time (minutes) spent in higher intensity physical activity over the 6 week study period

  • Session number [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Number of 30-minute treadmill sessions completed

  • Total session number [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Number of total treadmill sessions (any duration)

  • Number of moderate sessions [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Number of treadmill sessions at moderate intensity exercise

  • Total walking time [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Total time walking on treadmill

  • Consecutive exercise sessions [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Number of consecutive exercise sessions completed (3 days/week X 6 weeks)

  • Post-discharge exercise [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Quantity and frequency of exercise during 4-week post-discharge follow-up

  • Relapse to drug use [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Relapse to cocaine and other drug use post discharge


Estimated Enrollment: 50
Study Start Date: May 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral Incentives
Vouchers for complying with target behavior
Behavioral: Behavioral Incentives
Vouchers for complying with target behavior of treadmill walking
Placebo Comparator: Education Control
Education class
Behavioral: Education Control
Education class

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) at least 18 years of age
  • 2) female
  • 3) meet DSM-IV criteria for Cocaine Dependence (current)
  • 4) medically cleared by the Rubicon staff physician to participate in a regular exercise program
  • 5) able to provide informed consent for study participation.

Exclusion Criteria:

  • 1)are pregnant
  • 2)present with cognitive impairment, psychiatric instability, or language barriers that limit their ability to provide informed consent and participate in research assessments.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283191

Locations
United States, Virginia
Rubicon, Inc.
Richmond, Virginia, United States, 23230
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Leila Z Islam, M.S. Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01283191     History of Changes
Other Study ID Numbers: PD301598 1R36DA030619-01, R36DA030619
Study First Received: January 24, 2011
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
substance use
drug use
drug abuse
exercise
physical activity

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014