Back to resultsAdding Exercise to Antidepressant Medication Treatment for Depression (TREAD)
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SSRI + LD
SSRI + PHD
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Exercise therapy, Complementary Therapies
Eligibility Criteria
Inclusion Criteria: Diagnosis of Major Depressive Disorder Score of 14 or higher on the Hamilton Depression Scale (HAM-D) 8 to 12 weeks of SSRI treatment, with at least 6 weeks at adequate doses Sedentary lifestyle Physically capable of exercise Body mass index (BMI) less than 40 kg/m2 Willing and able to comply with study requirements Exclusion Criteria: Significant cardiovascular disease or other medical conditions Uncontrolled hypertension Abnormal exercise stress test Hematologic disorders Comorbid disorders, including depression due to another comorbid condition, psychotic disorder, bipolar disorder, schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder (OCD) Alcohol and/or substance abuse in the past 6 months Hospitalization for mental illness within the past year High suicide risk Use of psychopharmacological or psychotherapeutic treatment other than SSRIs Failure to respond to two or more adequate pharmacological treatments during the current depressive episode Significantly elevated blood lipids Pregnancy
Sites / Locations
- University of Texas Southwestern Medical Center at Dallas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SSRI+ LD
SSRI+ PHD
Arm Description
A low dose aerobic exercise (LD) augmentation intervention to SSRI
A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI
Outcomes
Primary Outcome Measures
Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated)
The primary outcome measure- percentage of participants with remission (score of 12 or less on Inventory for Depressive Symptomatology- Clinician-rated). The change over time in probability of remission (IDS-C30 score ≤ 12) was compared between groups using a generalized linear mixed model (GLMM)41 as implemented in SAS (Proc Glimmix; SAS Institute Inc, Cary, North Carolina).
Secondary Outcome Measures
Full Information
NCT ID
NCT00076258
First Posted
January 16, 2004
Last Updated
September 1, 2020
Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00076258
Brief Title
Adding Exercise to Antidepressant Medication Treatment for Depression
Acronym
TREAD
Official Title
Treatment With Exercise Augmentation for Depression (TREAD)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will assess the effectiveness of an exercise program in improving antidepressant medication treatment for individuals with major depressive disorder (MDD).
Detailed Description
Partial response to antidepressant treatment is common in people with MDD and is associated with significant morbidity and reduced quality of life. Pharmacological therapies have been used to augment the effect of antidepressants; however, such therapies are associated with a range of adverse effects. Studies indicate that exercise may be safe and effective in augmenting depression treatment. This study will determine whether exercise can complement selective serotonin reuptake inhibitor (SSRI) therapy in people with MDD who have residual symptoms of depression despite drug treatment.
Participants will be randomly assigned to either high frequency exercise or low frequency exercise for 12 weeks. Depression symptoms will be measured weekly. Quality of life and satisfaction with the study will also be measured. Depression scales and self-reports will be used to assess participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Exercise therapy, Complementary Therapies
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SSRI+ LD
Arm Type
Experimental
Arm Description
A low dose aerobic exercise (LD) augmentation intervention to SSRI
Arm Title
SSRI+ PHD
Arm Type
Experimental
Arm Description
A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI
Intervention Type
Behavioral
Intervention Name(s)
SSRI + LD
Intervention Description
Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.
Intervention Type
Behavioral
Intervention Name(s)
SSRI + PHD
Intervention Description
Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.
Primary Outcome Measure Information:
Title
Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated)
Description
The primary outcome measure- percentage of participants with remission (score of 12 or less on Inventory for Depressive Symptomatology- Clinician-rated). The change over time in probability of remission (IDS-C30 score ≤ 12) was compared between groups using a generalized linear mixed model (GLMM)41 as implemented in SAS (Proc Glimmix; SAS Institute Inc, Cary, North Carolina).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Major Depressive Disorder
Score of 14 or higher on the Hamilton Depression Scale (HAM-D)
8 to 12 weeks of SSRI treatment, with at least 6 weeks at adequate doses
Sedentary lifestyle
Physically capable of exercise
Body mass index (BMI) less than 40 kg/m2
Willing and able to comply with study requirements
Exclusion Criteria:
Significant cardiovascular disease or other medical conditions
Uncontrolled hypertension
Abnormal exercise stress test
Hematologic disorders
Comorbid disorders, including depression due to another comorbid condition, psychotic disorder, bipolar disorder, schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder (OCD)
Alcohol and/or substance abuse in the past 6 months
Hospitalization for mental illness within the past year
High suicide risk
Use of psychopharmacological or psychotherapeutic treatment other than SSRIs
Failure to respond to two or more adequate pharmacological treatments during the current depressive episode
Significantly elevated blood lipids
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhukar Trivedi, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12392873
Citation
Dunn AL, Trivedi MH, Kampert JB, Clark CG, Chambliss HO. The DOSE study: a clinical trial to examine efficacy and dose response of exercise as treatment for depression. Control Clin Trials. 2002 Oct;23(5):584-603. doi: 10.1016/s0197-2456(02)00226-x.
Results Reference
background
PubMed Identifier
11427783
Citation
Dunn AL, Trivedi MH, O'Neal HA. Physical activity dose-response effects on outcomes of depression and anxiety. Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S587-97; discussion 609-10. doi: 10.1097/00005768-200106001-00027.
Results Reference
background
PubMed Identifier
10192589
Citation
Crismon ML, Trivedi M, Pigott TA, Rush AJ, Hirschfeld RM, Kahn DA, DeBattista C, Nelson JC, Nierenberg AA, Sackeim HA, Thase ME. The Texas Medication Algorithm Project: report of the Texas Consensus Conference Panel on Medication Treatment of Major Depressive Disorder. J Clin Psychiatry. 1999 Mar;60(3):142-56.
Results Reference
background
PubMed Identifier
16394971
Citation
Galper DI, Trivedi MH, Barlow CE, Dunn AL, Kampert JB. Inverse association between physical inactivity and mental health in men and women. Med Sci Sports Exerc. 2006 Jan;38(1):173-8. doi: 10.1249/01.mss.0000180883.32116.28.
Results Reference
background
PubMed Identifier
16883145
Citation
Trivedi MH, Greer TL, Grannemann BD, Chambliss HO, Jordan AN. Exercise as an augmentation strategy for treatment of major depression. J Psychiatr Pract. 2006 Jul;12(4):205-13. doi: 10.1097/00131746-200607000-00002.
Results Reference
background
PubMed Identifier
27936452
Citation
Toups M, Carmody T, Greer T, Rethorst C, Grannemann B, Trivedi MH. Exercise is an effective treatment for positive valence symptoms in major depression. J Affect Disord. 2017 Feb;209:188-194. doi: 10.1016/j.jad.2016.08.058. Epub 2016 Oct 15.
Results Reference
derived
PubMed Identifier
27561137
Citation
Suterwala AM, Rethorst CD, Carmody TJ, Greer TL, Grannemann BD, Jha M, Trivedi MH. Affect Following First Exercise Session as a Predictor of Treatment Response in Depression. J Clin Psychiatry. 2016 Aug;77(8):1036-42. doi: 10.4088/JCP.15m10104.
Results Reference
derived
PubMed Identifier
23171815
Citation
Rethorst CD, Sunderajan P, Greer TL, Grannemann BD, Nakonezny PA, Carmody TJ, Trivedi MH. Does exercise improve self-reported sleep quality in non-remitted major depressive disorder? Psychol Med. 2013 Apr;43(4):699-709. doi: 10.1017/S0033291712001675. Epub 2012 Aug 29.
Results Reference
derived
PubMed Identifier
21658349
Citation
Trivedi MH, Greer TL, Church TS, Carmody TJ, Grannemann BD, Galper DI, Dunn AL, Earnest CP, Sunderajan P, Henley SS, Blair SN. Exercise as an augmentation treatment for nonremitted major depressive disorder: a randomized, parallel dose comparison. J Clin Psychiatry. 2011 May;72(5):677-84. doi: 10.4088/JCP.10m06743.
Results Reference
derived
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Adding Exercise to Antidepressant Medication Treatment for Depression
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