Clinical trial NCT02176408: Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression
Official title: Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Depression
MDD
Exercise
Physical Activity
Treatment
Behavioral Activation
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-06-27
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Week 16
Secondary outcomes:
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Week 16
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Week 16
measure: Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
timeFrame: Week 16
measure: Logical Memory
timeFrame: Week 16
measure: Continuous Performance Test- Identical Pairs
timeFrame: Week 16
measure: 7 Day Physical Activity Recall (PAR)
timeFrame: Week 16
measure: Brain-derived Neurotrophic Factor (BDNF)
timeFrame: Week 16
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Kristin Szuhany, M.A.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.