Effectiveness of Coping Training for People With HIV Experiencing Treatment Side Effects (The Balance Project)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00643903
First received: March 24, 2008
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

This study will evaluate the effectiveness of cognitive behavioral coping training in improving side effect management and treatment adherence in HIV-infected patients who are taking antiretroviral medications.


Condition Intervention
HIV Infections
Behavioral: Cognitive behavioral coping effectiveness training
Behavioral: Standard care
Behavioral: Single group workshop on coping effectiveness training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Balance Project - RCT of an HIV Treatment Side Effects Coping Intervention

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Quality of life [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Medication adherence [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: April 2004
Study Completion Date: February 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive five individual sessions of coping effectiveness training.
Behavioral: Cognitive behavioral coping effectiveness training
Coping effectiveness training will include five individual 90-minute counseling sessions. The sessions will focus on coping with stress, dealing with medication side effects, and staying on track with medications.
Active Comparator: 2
Participants will receive standard care and one delayed group workshop of coping effectiveness training.
Behavioral: Standard care
Participants will receive standard of care for HIV infections.
Behavioral: Single group workshop on coping effectiveness training
Participants will attend one group workshop covering the same material as in the individual sessions. The workshop will be delivered after completion of the Month 18 final assessment.

Detailed Description:

HIV is a virus that is transmitted through the exchange of bodily fluids, primarily through sexual intercourse. HIV infections can lead to acquired immunodeficiency syndrome (AIDS), a disease that breaks down the immune system and allows for entry of life-threatening secondary infections. Antiretroviral therapy (ART) has proven to effectively inhibit the replication of HIV and has resulted in a reduction in HIV-related deaths. People infected with HIV who are receiving ART, however, may be confronted with negative physical and emotional side effects. These side effects can impact quality of life (QOL), adherence to medical care, and decisions about health care. Stress and Coping Theory (SCT) is a person-centered approach that considers stressful experiences as person-environment transactions. A cognitive behavioral treatment based upon SCT may help to eliminate or reduce the negative impact of side effects, improve QOL, and maximize benefit from treatment among people living with HIV. This study will evaluate the effectiveness of cognitive behavioral coping training in improving side effect management and treatment adherence in HIV-infected people who are taking ART medications.

This study will involve two phases. Phase 1 will be conducted over 12 months and will include two 1-hour interviews with questions about personal life, family, friends, medications, and medication side effects. After the first interview, participants may be invited to participate in Phase 2, which will last 18 months.

During Phase 2, participants will complete five 2- to 3-hour interviews occurring at baseline and Months 3, 6, 12, and 18. Interviews will include questions about personal life, friends, family, health-related activities, drug-using behaviors, emotions, mental state, and educational background. Participants will be assigned randomly to one of two treatment groups:

  • Group 1 participants will receive five individual sessions of cognitive behavioral coping training, beginning after the Month 3 interview. The 90-minute sessions will focus on coping with stress, dealing with medication side effects, and staying on track with medications.
  • Group 2 participants will receive standard care and one group session of coping training, which will be held after the Month 18 interview. The group session will cover the same material that is covered in the individual sessions.

After the last follow-up interview, some participants may also be asked to complete an exit interview about thoughts and feelings on study participation.

  Eligibility

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

Inclusion Criteria:

  • Confirmed presence of HIV infection
  • Currently receiving ART
  • Experiencing ART side effects

Exclusion Criteria:

  • Currently enrolled in another trial
  • Evidence of psychosis or cognitive impairment
  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: NCT00643903

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94105
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Mallory O. Johnson, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00643903     History of Changes
Other Study ID Numbers: R01 MH068208, R01MH068208, DAHBR 9A-ASGA
Study First Received: March 24, 2008
Last Updated: January 18, 2012
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
Side Effects
Adherence
Coping
HIV
AIDS
Complementary Therapies

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Iatrogenic Disease
Drug-Related Side Effects and Adverse Reactions
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Disease Attributes
Pathologic Processes
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on October 19, 2014