Depression Clinical Trial
Official title:
Treatment of Depression With Massage in HIV
The purpose of this study is to determine the effect of massage therapy on depression, quality of life and plasma cortisol levels in subjects with advanced HIV disease.
This is a study to assess the usefulness of massage therapy for treatment of depression and
improvement in the quality of life in patients with HIV. This study will define the clinical
and biologic response to massage therapy in patients with HIV and depression who are
clinically stable and on a fixed medical regimen. Depression is a co-morbid condition in
individuals with advanced HIV disease and has a negative impact on quality of life.
Depression in HIV-infected patients also has been associated with a decrease in adherence to
medications and progression of clinical disease. While pharmacologic therapy for depression
have resulted in variable success in managing this problem, it is associated with an
increase in the number of medications that these patients are required to take, potential
for additional drug-drug interactions, and many adverse events. In patients with advanced
stage HIV disease, palliative care is often a priority and identifying new treatment
modalities that do not require additional medications while improve clinical symptoms and
overall quality of life is of the utmost importance. Pilot studies with massage therapy have
been performed in HIV-infected and uninfected individuals. These studies have shown a
reduction in depression scores in HIV-uninfected subjects. In HIV-infected patients, massage
therapy has been shown to improve quality of life measures and decrease plasma cortisol
levels.
The specific aims of this proposal are 1) to determine the effect of massage therapy on
depression in subjects with advanced HIV disease, 2) to investigate the effect of massage
therapy on quality of life in subjects with advanced HIV disease, and 3) to investigate the
effect of massage therapy on plasma cortisol levels in subjects with advanced HIV disease.
This study will randomize advanced stage HIV-infected subjects with depression in a 1:1:1
manner to massage therapy, "sham massage" or no physical intervention. The massage and "sham
massage" groups will be treated for one hour, twice per week, for 8 weeks. All enrolled
subjects will have depression measured (Hamilton Depression Scale) at baseline, weeks 1, 2,
4, 6 and 8, and quality of life (SF-36), and pain assessments (Gracely Pain Scale) at
baseline, weeks 4 and 8. In addition, 24-hour urine free cortisol, lymphocyte subsets and
HIV RNA measurements will be assessed at baseline and weeks 4 and 8. This will be a
rigorously controlled clinical trial using validated measures to assess the clinical
(depression and quality of life), and biologic (cortisol levels) effect of massage therapy
on subjects with advanced stage HIV disease and clinical depression.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A |