TREAD: TReatment with Exercise Augmentation for Depression: Study rationale and design

Madhukar H. Trivedi, Tracy L. Greer, Bruce D. Grannemann, Timothy S. Church, Daniel I. Galper, Prabha Sunderajan, Stephen R. Wisniewski, Heather O. Chambliss, Alexander N. Jordan, Carrie Finley, Thomas J. Carmody

Research output: Contribution to journalArticle

67 Citations (Scopus)

Abstract

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. Purpose: 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.

Original languageEnglish (US)
Pages (from-to)291-305
Number of pages15
JournalClinical Trials
Volume3
Issue number3
DOIs
StatePublished - 2006

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Exercise
Depression
Therapeutics
Major Depressive Disorder
Depressive Disorder
Antidepressive Agents
Randomized Controlled Trials
Research
National Institute of Mental Health (U.S.)
Serotonin Uptake Inhibitors
Mental Health
Pharmacology

ASJC Scopus subject areas

  • Medicine(all)

Cite this

TREAD : TReatment with Exercise Augmentation for Depression: Study rationale and design. / Trivedi, Madhukar H.; Greer, Tracy L.; Grannemann, Bruce D.; Church, Timothy S.; Galper, Daniel I.; Sunderajan, Prabha; Wisniewski, Stephen R.; Chambliss, Heather O.; Jordan, Alexander N.; Finley, Carrie; Carmody, Thomas J.

In: Clinical Trials, Vol. 3, No. 3, 2006, p. 291-305.

Research output: Contribution to journalArticle

Trivedi, MH, Greer, TL, Grannemann, BD, Church, TS, Galper, DI, Sunderajan, P, Wisniewski, SR, Chambliss, HO, Jordan, AN, Finley, C & Carmody, TJ 2006, 'TREAD: TReatment with Exercise Augmentation for Depression: Study rationale and design', Clinical Trials, vol. 3, no. 3, pp. 291-305. https://doi.org/10.1191/1740774506cn151oa
Trivedi, Madhukar H. ; Greer, Tracy L. ; Grannemann, Bruce D. ; Church, Timothy S. ; Galper, Daniel I. ; Sunderajan, Prabha ; Wisniewski, Stephen R. ; Chambliss, Heather O. ; Jordan, Alexander N. ; Finley, Carrie ; Carmody, Thomas J. / TREAD : TReatment with Exercise Augmentation for Depression: Study rationale and design. In: Clinical Trials. 2006 ; Vol. 3, No. 3. pp. 291-305.
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