TREAD: TReatment with Exercise Augmentation for Depression: study rationale and design.
BACKGROUND
Despite recent advancements in the pharmacological treatment of major depressive disorder (MDD), over half of patients who receive treatment with antidepressant medication do not achieve full remission of symptoms. There is evidence that exercise can reduce depressive symptomatology when used as a treatment for MDD. However, no randomized controlled trials have evaluated exercise as an augmentation strategy for patients with carefully diagnosed MDD who remain symptomatic following an adequate acute phase trial of antidepressant therapy.


OBJECTIVE
TReatment with Exercise Augmentation for Depression (TREAD) is an NIMH-funded, randomized, controlled trial designed to assess the relative efficacy of two doses of aerobic exercise to augment selective serotonin reuptake inhibitor (SSRI) treatment of MDD.


METHODS
The TREAD study includes 12 weeks of acute phase treatment with a 12-week post-treatment follow-up. In addition to looking at change in depressive symptoms as a primary outcome, it also includes comprehensive assessment of psychosocial function and treatment adherence.


RESULTS
This paper reviews the rationale and design of TREAD and illustrates how we address several key issues in contemporary patient-oriented research on MDD: 1) the use of augmentation strategies in the treatment of depressive disorders in general, 2) the use of non-pharmacological strategies in the treatment of depressive disorders, 3) the considerations of designing a well-controlled trial using two active treatment groups, and 4) the implementation of an adherence program for the use of exercise as a treatment strategy.


CONCLUSIONS
The TREAD study is uniquely designed to overcome sources of potential bias and threats to internal and external validity that have limited prior research on the mental health effects of exercise. The study is facilitated by the development of a multidisciplinary research team that includes experts in both depression treatment and exercise physiology, as well as other related fields.
Trivedi
Madhukar H
MH
Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas, USA. madhukar.trivedi@utsouthwestern.edu
Greer
Tracy L
TL
Grannemann
Bruce D
BD
Church
Timothy S
TS
Galper
Daniel I
DI
Sunderajan
Prabha
P
Wisniewski
Stephen R
SR
Chambliss
Heather O
HO
Jordan
Alexander N
AN
Finley
Carrie
C
Carmody
Thomas I
TI
D000293:Adolescent; D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003866:Depressive Disorder / Q000188:drug therapy / Q000628:therapy*; D005081:Exercise Therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*
D000928:Antidepressive Agents; D017367:Selective Serotonin Reuptake Inhibitors