Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression

Summary

Major depressive disorder (MDD) is the leading cause of disability in the developed world and is associated with lost productivity, increased health care utilization, and mortality. Several empirically supported treatments, such as antidepressant medication and cognitive behavioral therapy, exist for the treatment of MDD; however, studies have shown that as many as 34% of individuals do not respond to these treatments. Exercise and stretching interventions represent alternative strategies associated with strong effect sizes in past studies. Additionally, exercise has been shown to enhance cognitive functioning, especially attention and memory. This study aims to investigate the effect of a combined aerobic exercise and behavioral activation treatment (BA) for MDD. Behavioral activation treatment involves completing both pleasant and mastery-based activities with the goal of enhancing mood. The current study will recruit 32 MDD patients for an active treatment phase of nine 60-90 minute sessions (6 weekly sessions and 3 biweekly sessions) of either BA plus exercise (BA+EX) or BA plus stretching (BA+STR). The purpose of this study is to identify if adding aerobic exercise to a brief psychosocial treatment can improve mood above and beyond an active control condition.

Conditions

• Major Depressive Disorder

Interventions

BEHAVIORAL

Behavioral Activation

Behavioral Activation Therapy (BA). All participants will receive a standard behavioral activation treatment based on the manualized treatment described by Lejuez et al., 2011. Treatment will be delivered in 60-minute weekly sessions over a 6-week period followed by 3 biweekly booster sessions. Behavioral activation includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

BEHAVIORAL

Exercise Intervention

Exercise Intervention (EX). The exercise intervention will immediately follow each of the first six weekly BA sessions. Each EX session will comprise 30 minutes of either providing rationale for the program or reviewing the previous week's progress. As part of the intervention, participants will be asked to perform 40 minutes of aerobic exercise at 60-75% of maximum heart rate on three days each week, with 5 minute stretching warm up and cool down. We will help all participants initiate and plan their at-home program of exercise.

BEHAVIORAL

Stretching Intervention

Stretching Intervention (STR). The stretching intervention will also follow each of the first six weekly BA sessions. These sessions will comprise 30 minutes of providing rationale for the stretching program or reviewing the previous week's progress. As part of the intervention, participants will be asked to perform 50 minutes of stretching on three days each week. Participants in this condition will be provided with a 50-minute DVD of stretching exercises and will work with the therapist to plan their at-home stretching exercises.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Boston University Charles River Campus

  lead OTHER

Principal Investigators

• Kristin Szuhany, M.A. · Boston University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-06-30

Primary Completion

2016-08-31

Completion

2016-08-31

Countries

• United States

Study Locations