跳至主要内容
临床试验/NCT01158443
NCT01158443已完成4 期

Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS

Research Foundation for Mental Hygiene, Inc.1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
46
试验地点
1
主要终点
Employment or enrollment in vocational classes as measured by Goal Attainment Scaling

研究概览

简要总结

This is an integrated medication/behavioral intervention program to increase energy, activity level and goal attainment in a sample of HIV+ adults whose presenting problems include both clinically significant fatigue and unmet vocational goals. Based on previous studies, the investigators found that many patients fail to achieve desired goals even though energy is restored by medication. To address this failure of goal attainment, the investigators will evaluate a behavioral intervention, originally based on Behavioral Activation Treatment for Depression, and modified as Behavioral Activation Program for Energy and Productivity or BA-PEP. The intervention will be conducted with patients who experience clinically significant fatigue and who want to work or receive work-related training (paid or volunteer, part time or full time) or education once energy improves with medication (armodafinil).

详细描述

The investigators propose an integrated medication/behavioral intervention program to increase energy, activity level and goal attainment in a sample of people with HIV/AIDS whose presenting problem is clinically significant fatigue and unmet vocational goals. Based on a recently completed randomized controlled trial (RCT) of modafinil and ongoing RCT of armodafinil, the investigators found that many patients fail to achieve desired goals even though energy is restored by medication. To address this failure of goal attainment, the team will develop and pilot a behavioral intervention, originally based on Behavioral Activation Treatment for Depression of Lejuez et al. and modified by Dr. Daughters as "Behavioral Activation Program for Energy and Productivity, or 'BA-PEP'". The intervention will be conducted with patients who experience significant fatigue, and who want to work or get work-related training or education once their energy improves with armodafinil treatment. It is intended for eventual implementation in HIV clinics and community agencies with work development programs.

The intervention development includes both formative work and pilot studies. The formative work comprises in-depth patient interviews, focus groups with providers, a Project Advisory Board, and a separate Work Group. Their input will be used to modify their BA-PEP intervention to promote achievement of goals selected by each patient, once fatigue has been ameliorated with armodafinil, and to further adapt the attention control supportive counseling intervention.

With this input, the investigators will conduct an exploratory study using BA-PEP with 12 patients responsive to armodafinil. After further modifications, investigators will conduct a feasibility trial with 30 armodafinil-responsive patients randomized 2:1 to BA-PEP or an attention control, supportive counseling. The main behavioral outcome is employment or taking classes (measured by Goal Attainment Scaling methodology). Secondary outcomes are reduced avoidance/increased activation (measured by the Behavioral Activation for Depression Scale), and increased environmental interactions (measured by the EROS: Environmental Rewards Observation Scale). Finally, they will develop training and supervision manuals to guide implementation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HIV+, ages 18-70
  • Under the care of a medical provider
  • Clinically significant fatigue
  • Speaks English
  • Able and willing to give informed consent
  • Patient seeks either work or vocational training but is blocked from doing so by current fatigue

排除标准

  • Primary care provider does not approve of study participation
  • Medical rule-outs such as anemia, hypothyroidism, hypogonadism or other condition that may account for fatigue
  • Abnormal EKG
  • Untreated major depressive disorder; psychosis, bipolar disorder
  • Current substance abuse/dependence
  • Clinically significant suicidal ideation

结局指标

主要结局

Employment or enrollment in vocational classes as measured by Goal Attainment Scaling

时间窗: 6 months

Goal Attainment Scaling assesses degree of success in reaching a pre-specified set of goals initially enumerated at study entry, with a 5-point score range. A score of zero is assigned to success in attaining the specified goal, with 2 greater and 2 lesser levels of accomplishment also specified.

次要结局

  • Increased environmental interactions as measured by the EROS: Environmental Rewards Observation Scale.(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Judith G. Rabkin, PhD

Research Scientist VI

Research Foundation for Mental Hygiene, Inc.

研究点 (1)

Loading locations...

相似试验