Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression

NCT02176408 | Completed Results

• 1 other identifier: F31MH100773-01A1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Major Depressive Disorder; Depression; MDD; Exercise; Physical Activity; Treatment; Behavioral Activation

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  The MADRS is a 10-item clinician-rated measure of correlates of depression. Specifically, this questionnaire measures the following: sadness, tension, sleep, appetite, concentration, lassitude, numbness, pessimism, and suicidal ideation. The scale ranges from 0-60 with higher totals indicating worse depression. The following are norms for severity: 0 to 6 - normal/symptom absent; 7 to 19 - mild depression; 20 to 34 - moderate depression; and \>34 - severe depression.

  Week 16

Secondary Outcomes (7)

• Beck Depression Inventory-II (BDI-II)

  Week 16

• Work and Social Adjustment Scale (WSAS)

  Week 16

• Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

  Week 16

• Logical Memory

  Week 16

• Continuous Performance Test- Identical Pairs

  Week 16

Study Arms (2)

Behavioral Activation plus Exercise

EXPERIMENTAL

Six weekly 60-minute sessions plus three 60-minute biweekly booster sessions of behavioral activation treatment Six weekly 30-minute sessions of the exercise intervention (with this intervention incorporated into the 60 minutes of the biweekly booster sessions)

Behavioral: Behavioral Activation; Behavioral: Exercise Intervention

Behavioral Activation plus Stretching

ACTIVE COMPARATOR

Six weekly 60-minute sessions plus three 60-minute biweekly booster sessions of behavioral activation treatment Six weekly 30-minute sessions of the stretching intervention (with this intervention incorporated into the 60 minutes of the biweekly booster sessions)

Behavioral: Behavioral Activation; Behavioral: Stretching Intervention

Interventions

Behavioral Activation BEHAVIORAL

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 Activation plus Exercise; Behavioral Activation plus Stretching

Exercise Intervention BEHAVIORAL

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 Activation plus Exercise

Stretching Intervention BEHAVIORAL

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.

Behavioral Activation plus Stretching

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ages 18-65 with a principal DSM-5 diagnosis of MDD or Persistent Depressive Disorder with a current Major Depressive Episode (as determined by the Anxiety and Related Disorders Interview Schedule-5)
• Sedentary (moderate-intensity exercise less than two days per week for at least 30 minutes each time for at least 3 months)
• Able to provide informed consent for the study
• Sufficient command of the English language

You may not qualify if:

• Current or past psychotic disorders of any type, bipolar disorder (I, II, or NOS), schizophrenia or schizoaffective disorder, anorexia, bulimia, or alcohol or drug dependence
• Currently suicidal or high suicide risk (as evaluated by the Columbia Suicide Severity Rating Scale and BDI suicide item)
• Risk for exercise according to the Physical Activity Readiness Questionnaire (PAR-Q) in accordance with the guidelines set forth by the American College of Sports Medicine (ACSM) (i.e., existence of the conditions in the next bullet point)
• Physical conditions (e.g.,heart conditions, diabetes, asthma or another lung disease, bone/joint problems, or seizure disorder) interfering with the ability to exercise safely
• Individuals who have participated in cognitive behavioral therapy (CBT) directed towards the treatment of a mood disorder within three months of baseline, those simultaneously participating in another psychosocial treatment (other than supportive therapy) or those not currently stable (i.e., same dosage for at least 8 weeks) on psychotropic medications
• Women who are currently pregnant, plan to be pregnant in the next year, or currently breastfeeding

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

• Szuhany KL, Otto MW. Assessing BDNF as a mediator of the effects of exercise on depression. J Psychiatr Res. 2020 Apr;123:114-118. doi: 10.1016/j.jpsychires.2020.02.003. Epub 2020 Feb 8.

  PMID: 32065946 DERIVED

• Szuhany KL, Otto MW. Efficacy evaluation of exercise as an augmentation strategy to brief behavioral activation treatment for depression: a randomized pilot trial. Cogn Behav Ther. 2020 May;49(3):228-241. doi: 10.1080/16506073.2019.1641145. Epub 2019 Jul 30.

  PMID: 31357916 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Motor Activity

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

This study had limited power to detect overall treatment differences given higher levels of dropout than expected, had limited follow-up, and a lack of a waitlist (or no movement) control condition.

Results Point of Contact

• Title: Kristin Szuhany
• Organization: NYU Langone Health

kristin.szuhany@nyulangone.org

6467545161

Study Officials

• Kristin Szuhany, M.A.

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 27, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 10, 2019
• Results First Posted: September 10, 2019

Record last verified: 2019-08

Locations

US (1)