Clinical trial NCT00057538: Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV
Official title: Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV
Randomized Trial
Stress
Spirituality
Quality of Life
Complementary Therapies
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
Collaborators: name: University of California, San Diego
First posted: 2003-04-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: The purpose of this study is to determine the effectiveness of a stress management group intervention for people with HIV. The study will evaluate several outcomes, including perceived stress, quality of life, psychosocial factors, and physiological measures of stress.

Detailed description: It is well documented that living with HIV/AIDS can cause a great amount of stress, and evidence suggests that stress may hasten HIV disease progression by increasing viral replication and suppressing the immune response. Stress management intervention studies using more complex combinations of cognitive and relaxation therapies have shown improvements in both psychological and physiological measures in HIV infected persons. However, no studies have focused on only one intervention or have addressed the spiritual component using a comparable control group to determine which of these interventions is most effective.

Participants will be randomly assigned to receive either a spiritually-based cognitive intervention to an educational control group. The intervention will be given over a 10-week period, with 5 weekly classes, 4 weekly automated phone calls, and one final class meeting. Assessments will be conducted at pre-intervention, fifth class midpoint, tenth week post-intervention, and 3-month follow-up. Time commitment can vary from 6 months to 9 months, depending on when participants are screened.

Eligibility criteria: Inclusion Criteria:

* HIV infected for at least 6 months
* Ability to read and write English

Exclusion Criteria:

* Drug use within the past 6 months
* Cognitive impairment or dementia
* Diagnosis that may affect cortisol levels, such as diabetes, cancer, or asthma
* Loss of family/loved one in past 3 months
* Started a relaxation therapy in past 3 months
* History or current practice of the RISE program, rosary, chanting, or Transcendental Meditation (TM)
* Acute infection in past month
* Change of HAART or drug regimen in past month

Primary outcomes:
measure: Intrusive Thoughts
measure: Perceived Stress
measure: Trait Anxiety
measure: Trait Anger
Secondary outcomes:
measure: Spiritual Well-Being (FACIT-SpEx)
measure: Quality of Life Enjoyment and Satisfaction
measure: Ways of Coping
measure: Urinary cortisol levels
measure: Urinary catecholamines
measure: Salivary cortisol levels
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
Study officials:
affiliation: California San Diego Healthcare System
name: Jill E. Bormann, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bormann, JE. Frequent, silent mantram repetition: A jacuzzi for the mind. Topics in Emergency Medicine 27(2): 163-166, 2005.