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Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression

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ClinicalTrials.gov Identifier: NCT02176408
Recruitment Status : Unknown
Verified January 2016 by Boston University.
Recruitment status was:  Active, not recruiting
First Posted : June 27, 2014
Last Update Posted : April 6, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Boston University

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Behavioral Activation Behavioral: Exercise Intervention Behavioral: Stretching Intervention Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression
Study Start Date : June 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Behavioral Activation plus Exercise

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 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.

Active Comparator: Behavioral Activation plus Stretching

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 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: 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 Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Change from baseline to week 4/week 8/week 12/week 16 ]
    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.


Secondary Outcome Measures :
  1. Beck Depression Inventory-II (BDI-II) [ Time Frame: changes from baseline to week 16 (assessed each week) ]
    The BDI is a widely used 21-item, self-report inventory designed to measure severity of depressive symptoms.

  2. Work and Social Adjustment Scale (WSAS) [ Time Frame: Change from baseline to week 4/week 8/week 12/week 16 ]
    The WSAS is a self-report scale of functional impairment attributable to an identified problem, in this case MDD.

  3. Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Change from baseline to week 4/week 8/week 12/week 16 ]
    The Q-LES-Q rates 16 aspects of quality of life, including physical health, mood, activities of daily living, and overall life satisfaction.

  4. Clinical Global Impressions- Improvement/Severity [ Time Frame: Change from baseline to week 4/week 8/week 12/week 16 ]
    The CGI-I is a measure of global improvement rated from 1 (very much improved) to 7 (very much worse). The CGI-S measures global severity rated from 1 (not ill) to 7 (extremely ill).

  5. Logical Memory [ Time Frame: change from baseline to week 12 to week 16 ]
    Participants will be read a story and asked to remember as many details as possible.

  6. Continuous Performance Test [ Time Frame: change from baseline to week 12 to week 16 ]
    Participants' attention will be assessed using the CPT which is a choice reaction time task which requires a subject to respond whenever two identical stimuli appear in a row within a sequence of rapidly flashed trials.

  7. Actigraphy measurements [ Time Frame: change from baseline to week 4 to week 8 ]
    Participant will wear an actigraph (looks like a watch) which will collect information about physical activity that will supplement self-report data.

  8. 7 Day Physical Activity Recall (PAR) [ Time Frame: changes from baseline to week 16 (assessed each week) ]
    The PAR is is an interviewer-administered measure of physical activity behavior that will be used as a self-report validation measure of amount of physical activity completed.

  9. Submaximal Exercise Test [ Time Frame: changes from baseline to week 4/week 8/week 16 ]
    The submaximal exercise test will be used to assess the outcome of the exercise intervention at multiple timepoints and as a screening tool during baseline measurements. A protocol will be used that consists of 2-min stages changing the speed and grade of the treadmill as the stages progress. During the exercise testing, participants will be asked to rate their perceived exertion (using the Borg Rating of Perceived Exertion Scale) at the end of each stage.

  10. Brain-derived neurotrophic factor (BDNF) [ Time Frame: changes from baseline to week 4/week 8/week 16 ]
    Blood samples (approximately 1 tsp) will be collected at baseline, week 4, week 8, and week 16 to test serum BDNF. Blood will be collected both before and after exercise (2 collections per visit) to measure changes in resting levels of BDNF (before exercise collections) and changes in BDNF response after exercise (difference between resting and after exercise levels).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02176408


Locations
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Boston University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Kristin Szuhany, M.A. Boston University

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT02176408     History of Changes
Other Study ID Numbers: F31MH100773-01A1 ( U.S. NIH Grant/Contract )
F31MH100773-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: January 2016

Keywords provided by Boston University:
Major Depressive Disorder
Depression
MDD
Exercise
Physical Activity
Treatment
Behavioral Activation

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders