Overview

This trial is active, not recruiting.

Condition major depressive disorder
Treatments behavioral activation, exercise intervention, stretching intervention
Sponsor Boston University
Collaborator National Institute of Mental Health (NIMH)
Start date June 2014
End date June 2016
Trial size 38 participants
Trial identifier NCT02176408, F31MH100773-01A1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(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 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.
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.
(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 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.
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.

Primary Outcomes

Measure
Montgomery-Asberg Depression Rating Scale (MADRS)
time frame: Change from baseline to week 4/week 8/week 12/week 16

Secondary Outcomes

Measure
Beck Depression Inventory-II (BDI-II)
time frame: changes from baseline to week 16 (assessed each week)
Work and Social Adjustment Scale (WSAS)
time frame: Change from baseline to week 4/week 8/week 12/week 16
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
time frame: Change from baseline to week 4/week 8/week 12/week 16
Clinical Global Impressions- Improvement/Severity
time frame: Change from baseline to week 4/week 8/week 12/week 16
Logical Memory
time frame: change from baseline to week 12 to week 16
Continuous Performance Test
time frame: change from baseline to week 12 to week 16
Actigraphy measurements
time frame: change from baseline to week 4 to week 8
7 Day Physical Activity Recall (PAR)
time frame: changes from baseline to week 16 (assessed each week)
Submaximal Exercise Test
time frame: changes from baseline to week 4/week 8/week 16
Brain-derived neurotrophic factor (BDNF)
time frame: changes from baseline to week 4/week 8/week 16

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression
Principal investigator Kristin Szuhany, M.A.
Description Individuals with major depressive disorder (MDD) will be recruited to participate in a free treatment trial of a combined exercise or stretching regimen plus behavioral activation treatment. All individuals will receive 6 weekly and 3 biweekly 1-hour sessions of behavioral activation treatment. Behavioral activation involves exploring values in different life areas (relationships, education/career, interests, etc.) and scheduling activities in line with these values. Research has shown that behavioral activation treatment can improve mood and alleviate depressive symptoms. In addition, participants will be randomized (like a flip of a coin) to either an additional aerobic exercise intervention or an additional stretching intervention. These interventions will take place for half an hour after the first 6 weeks of the behavioral activation intervention. The purpose of this study is to examine if adding an aerobic exercise intervention to a brief psychosocial treatment can improve mood above and beyond an active control condition. Throughout the study, participants will complete computer, questionnaire, and interview assessments as well as exercise tests and a blood draw. The details of each visit are listed below. For full completion of this study, participants can earn up to $100. Screening visit: diagnostic interview, assessment for physical activity risk (brief meeting with physician) Baseline visit (week 0): submaximal exercise test, blood draw, questionnaire measures, computer tests Treatment visit 1 (week 1): BA treatment + EX/STR intervention, brief questionnaires Treatment visit 2 (week 2): BA treatment + EX/STR intervention, brief questionnaires Treatment visit 3 (week 3): BA treatment + EX/STR intervention, brief questionnaires Treatment visit 4 (week 4): BA treatment + EX/STR intervention, questionnaires, submaximal exercise test, blood draw Treatment visit 5 (week 5): BA treatment + EX/STR intervention, brief questionnaires Treatment visit 6 (week 6): BA treatment + EX/STR intervention, brief questionnaires Treatment visit 7 (week 8): BA treatment, questionnaires, submaximal exercise test, blood draw Treatment visit 8 (week 10): BA treatment, brief questionnaires Treatment visit 9 (week 12): BA treatment, questionnaire measures Final assessment (week 16): submaximal exercise test, blood draw, questionnaire measures, computer tests
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Boston University.