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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 : Completed
First Posted : June 27, 2014
Results First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Boston University Charles River Campus

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Behavioral: Behavioral Activation
Behavioral: Exercise Intervention
Behavioral: Stretching Intervention
Enrollment 38
Recruitment Details  
Pre-assignment Details Seven participants were enrolled in the study but not randomized to one of the two intervention arms. Four participants were excluded after the screening visit due to not meeting study inclusion criteria. Three participants completed screening but discontinued the study prior to attending the baseline visit (during which randomization occurs).
Arm/Group Title Behavioral Activation Plus Exercise Behavioral Activation Plus Stretching
Hide Arm/Group Description

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Exercise Intervention (EX). Each EX session had 30 minutes of either providing rationale for the program, reviewing motivational strategies, or reviewing the previous week’s progress.

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Stretching Intervention (STR). These sessions had 30 minutes of providing rationale for the stretching program, reviewing motivational strategies, or reviewing the previous week’s progress.

Period Title: Overall Study
Started 15 16
Completed 9 12
Not Completed 6 4
Arm/Group Title Behavioral Activation Plus Exercise Behavioral Activation Plus Stretching Total
Hide Arm/Group Description

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Exercise Intervention (EX). Each EX session had 30 minutes of either providing rationale for the program, reviewing motivational strategies, or reviewing the previous week’s progress.

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Stretching Intervention (STR). These sessions had 30 minutes of providing rationale for the stretching program, reviewing motivational strategies, or reviewing the previous week’s progress.

Total of all reporting groups
Overall Number of Baseline Participants 15 16 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
16
 100.0%
31
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 16 participants 31 participants
30.5  (12.7) 36.5  (13.7) 34.2  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
Female
10
  66.7%
14
  87.5%
24
  77.4%
Male
5
  33.3%
2
  12.5%
7
  22.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 16 participants 31 participants
15 16 31
1.Primary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description 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.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Activation Plus Exercise Behavioral Activation Plus Stretching
Hide Arm/Group Description:

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Exercise Intervention (EX). Each EX session had 30 minutes of either providing rationale for the program, reviewing motivational strategies, or reviewing the previous week’s progress.

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Stretching Intervention (STR). These sessions had 30 minutes of providing rationale for the stretching program, reviewing motivational strategies, or reviewing the previous week’s progress.

Overall Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: score on a scale
11.2  (7.5) 16.0  (9.5)
2.Secondary Outcome
Title Beck Depression Inventory-II (BDI-II)
Hide Description The BDI is a widely used 21-item, self-report inventory designed to measure severity of depressive symptoms. Scores range from 0-63 with higher scores indicating worse depression. The following are severity norms for the measure: 0–13: minimal depression; 14–19: mild depression; 20–28: moderate depression; and 29–63: severe depression.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Activation Plus Exercise Behavioral Activation Plus Stretching
Hide Arm/Group Description:

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Exercise Intervention (EX). Each EX session had 30 minutes of either providing rationale for the program, reviewing motivational strategies, or reviewing the previous week’s progress.

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Stretching Intervention (STR). These sessions had 30 minutes of providing rationale for the stretching program, reviewing motivational strategies, or reviewing the previous week’s progress.

Overall Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: score on a scale
8.7  (9.5) 13.2  (9.6)
3.Secondary Outcome
Title Work and Social Adjustment Scale (WSAS)
Hide Description The WSAS is a self-report scale of functional impairment attributable to an identified problem, in this case MDD. Scores range from 0 to 40 with higher scores indicating worse functioning. A WSAS score above 20 appears to suggest moderately severe or worse psychopathology. Scores between 10 and 20 are associated with significant functional impairment but less severe clinicalsymptomatology. Scores below 10 appear to be associated with subclinical populations.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Activation Plus Exercise Behavioral Activation Plus Stretching
Hide Arm/Group Description:

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Exercise Intervention (EX). Each EX session had 30 minutes of either providing rationale for the program, reviewing motivational strategies, or reviewing the previous week’s progress.

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Stretching Intervention (STR). These sessions had 30 minutes of providing rationale for the stretching program, reviewing motivational strategies, or reviewing the previous week’s progress.

Overall Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: score on a scale
10.7  (10.5) 16.5  (12.5)
4.Secondary Outcome
Title Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Hide Description The Q-LES-Q rates 16 aspects of quality of life, including physical health, mood, activities of daily living, and overall life satisfaction. Scores range from 14 to 70 with lower scores indicating worse quality of life.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Activation Plus Exercise Behavioral Activation Plus Stretching
Hide Arm/Group Description:

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Exercise Intervention (EX). Each EX session had 30 minutes of either providing rationale for the program, reviewing motivational strategies, or reviewing the previous week’s progress.

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Stretching Intervention (STR). These sessions had 30 minutes of providing rationale for the stretching program, reviewing motivational strategies, or reviewing the previous week’s progress.

Overall Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: score on a scale
53.9  (9.0) 45.5  (10.6)
5.Secondary Outcome
Title Logical Memory
Hide Description Participants will be read a story and asked to remember as many details as possible. Raw scores are reported with a range in the current sample from from 17 to 47 with higher scores indicating better memory performance.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Activation Plus Exercise Behavioral Activation Plus Stretching
Hide Arm/Group Description:

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Exercise Intervention (EX). Each EX session had 30 minutes of either providing rationale for the program, reviewing motivational strategies, or reviewing the previous week’s progress.

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Stretching Intervention (STR). These sessions had 30 minutes of providing rationale for the stretching program, reviewing motivational strategies, or reviewing the previous week’s progress.

Overall Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: score on a scale
34.75  (10.54) 28.18  (6.29)
6.Secondary Outcome
Title Continuous Performance Test- Identical Pairs
Hide Description 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. Scores represent the average d' across 2 digit, 3 digit, and 4 digit trials. Average scores in this sample ranged from 1.76 to 4.24. Lower d' represents a better score.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Activation Plus Exercise Behavioral Activation Plus Stretching
Hide Arm/Group Description:

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Exercise Intervention (EX). Each EX session had 30 minutes of either providing rationale for the program, reviewing motivational strategies, or reviewing the previous week’s progress.

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Stretching Intervention (STR). These sessions had 30 minutes of providing rationale for the stretching program, reviewing motivational strategies, or reviewing the previous week’s progress.

Overall Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.99  (.41) 3.05  (.66)
7.Secondary Outcome
Title 7 Day Physical Activity Recall (PAR)
Hide Description 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. Metabolic equivalents (METs) of moderate and vigorous intensity activity are reported. METs of activity ranged from 0 to 1520 in this sample with higher numbers indicating more physical activity completed.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Activation Plus Exercise Behavioral Activation Plus Stretching
Hide Arm/Group Description:

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Exercise Intervention (EX). Each EX session had 30 minutes of either providing rationale for the program, reviewing motivational strategies, or reviewing the previous week’s progress.

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Stretching Intervention (STR). These sessions had 30 minutes of providing rationale for the stretching program, reviewing motivational strategies, or reviewing the previous week’s progress.

Overall Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: METs
752.89  (447.57) 530.00  (515.01)
8.Secondary Outcome
Title Brain-derived Neurotrophic Factor (BDNF)
Hide Description Blood samples (approximately 1 tsp) will be collected at baseline, week 4, week 8, and week 16 to test serum BDNF. Changes in resting BDNF levels were assessed. BDNF levels ranged from 14391 to 43020 ng/ml in this sample with higher levels indicating more BDNF.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Amount of individuals who had BDNF data available at Week 16.
Arm/Group Title Behavioral Activation Plus Exercise Behavioral Activation Plus Stretching
Hide Arm/Group Description:

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Exercise Intervention (EX). Each EX session had 30 minutes of either providing rationale for the program, reviewing motivational strategies, or reviewing the previous week’s progress.

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Stretching Intervention (STR). These sessions had 30 minutes of providing rationale for the stretching program, reviewing motivational strategies, or reviewing the previous week’s progress.

Overall Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: ng/mL
25996.86  (3807.37) 26601.11  (9237.28)
Time Frame Collected over the course of the entire study (16 weeks per participant)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Behavioral Activation Plus Exercise Behavioral Activation Plus Stretching
Hide Arm/Group Description

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Exercise Intervention (EX). Each EX session had 30 minutes of either providing rationale for the program, reviewing motivational strategies, or reviewing the previous week’s progress.

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 Therapy (BA). All participants received standard BA based on the manualized treatment described by Lejuez et al., 2011. BA includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.

Stretching Intervention (STR). These sessions had 30 minutes of providing rationale for the stretching program, reviewing motivational strategies, or reviewing the previous week’s progress.

All-Cause Mortality
Behavioral Activation Plus Exercise Behavioral Activation Plus Stretching
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/16 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Behavioral Activation Plus Exercise Behavioral Activation Plus Stretching
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/15 (6.67%)      2/16 (12.50%)    
General disorders     
Inpatient hospitalization  [1]  1/15 (6.67%)  1 0/16 (0.00%)  0
Psychiatric disorders     
Inpatient hospitalization  [2]  0/15 (0.00%)  0 1/16 (6.25%)  1
Social circumstances     
Inpatient hospitalization  [3]  0/15 (0.00%)  0 1/16 (6.25%)  1
Indicates events were collected by systematic assessment
[1]
Inpatient hospitalization due to dehydration
[2]
1 day inpatient hospitalization for suicidal ideation
[3]
4 day inpatient hospitalization for excessive alcohol consumption
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Behavioral Activation Plus Exercise Behavioral Activation Plus Stretching
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/15 (6.67%)      3/16 (18.75%)    
Gastrointestinal disorders     
Diarrhea   0/15 (0.00%)  0 2/16 (12.50%)  5
Injury, poisoning and procedural complications     
Sprained ankle   1/15 (6.67%)  1 0/16 (0.00%)  0
Musculoskeletal and connective tissue disorders     
back pain   0/15 (0.00%)  0 1/16 (6.25%)  1
Indicates events were collected by systematic assessment
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kristin Szuhany
Organization: NYU Langone Health
Phone: 6467545161
EMail: kristin.szuhany@nyulangone.org
Layout table for additonal information
Responsible Party: Boston University Charles River Campus
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 Submitted: June 24, 2014
First Posted: June 27, 2014
Results First Submitted: July 16, 2019
Results First Posted: September 10, 2019
Last Update Posted: September 10, 2019