Trial Outcomes & Findings for Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression (NCT NCT02176408)
NCT ID: NCT02176408
Last Updated: 2019-09-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
Week 16
Results posted on
2019-09-10
Participant Flow
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).
Participant milestones
| Measure |
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 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.
|
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 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 Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
9
|
12
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression
Baseline characteristics by cohort
| Measure |
Behavioral Activation Plus Exercise
n=15 Participants
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.
|
Behavioral Activation Plus Stretching
n=16 Participants
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
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.5 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
36.5 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
34.2 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16The 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.
Outcome measures
| Measure |
Behavioral Activation Plus Exercise
n=15 Participants
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.
|
Behavioral Activation Plus Stretching
n=16 Participants
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.
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
|
11.2 score on a scale
Standard Deviation 7.5
|
16.0 score on a scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Week 16The 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.
Outcome measures
| Measure |
Behavioral Activation Plus Exercise
n=15 Participants
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.
|
Behavioral Activation Plus Stretching
n=16 Participants
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.
|
|---|---|---|
|
Beck Depression Inventory-II (BDI-II)
|
8.7 score on a scale
Standard Deviation 9.5
|
13.2 score on a scale
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Week 16The 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.
Outcome measures
| Measure |
Behavioral Activation Plus Exercise
n=15 Participants
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.
|
Behavioral Activation Plus Stretching
n=16 Participants
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.
|
|---|---|---|
|
Work and Social Adjustment Scale (WSAS)
|
10.7 score on a scale
Standard Deviation 10.5
|
16.5 score on a scale
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: Week 16The 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.
Outcome measures
| Measure |
Behavioral Activation Plus Exercise
n=15 Participants
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.
|
Behavioral Activation Plus Stretching
n=16 Participants
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.
|
|---|---|---|
|
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
|
53.9 score on a scale
Standard Deviation 9.0
|
45.5 score on a scale
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Week 16Participants 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.
Outcome measures
| Measure |
Behavioral Activation Plus Exercise
n=15 Participants
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.
|
Behavioral Activation Plus Stretching
n=16 Participants
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.
|
|---|---|---|
|
Logical Memory
|
34.75 score on a scale
Standard Deviation 10.54
|
28.18 score on a scale
Standard Deviation 6.29
|
SECONDARY outcome
Timeframe: Week 16Participants' 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.
Outcome measures
| Measure |
Behavioral Activation Plus Exercise
n=15 Participants
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.
|
Behavioral Activation Plus Stretching
n=16 Participants
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.
|
|---|---|---|
|
Continuous Performance Test- Identical Pairs
|
2.99 score on a scale
Standard Deviation .41
|
3.05 score on a scale
Standard Deviation .66
|
SECONDARY outcome
Timeframe: Week 16The 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.
Outcome measures
| Measure |
Behavioral Activation Plus Exercise
n=15 Participants
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.
|
Behavioral Activation Plus Stretching
n=16 Participants
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.
|
|---|---|---|
|
7 Day Physical Activity Recall (PAR)
|
752.89 METs
Standard Deviation 447.57
|
530.00 METs
Standard Deviation 515.01
|
SECONDARY outcome
Timeframe: Week 16Population: Amount of individuals who had BDNF data available at Week 16.
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.
Outcome measures
| Measure |
Behavioral Activation Plus Exercise
n=7 Participants
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.
|
Behavioral Activation Plus Stretching
n=9 Participants
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.
|
|---|---|---|
|
Brain-derived Neurotrophic Factor (BDNF)
|
25996.86 ng/mL
Standard Deviation 3807.37
|
26601.11 ng/mL
Standard Deviation 9237.28
|
Adverse Events
Behavioral Activation Plus Exercise
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Behavioral Activation Plus Stretching
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Behavioral Activation Plus Exercise
n=15 participants at risk
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.
|
Behavioral Activation Plus Stretching
n=16 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Inpatient hospitalization
|
0.00%
0/15 • Collected over the course of the entire study (16 weeks per participant)
|
6.2%
1/16 • Number of events 1 • Collected over the course of the entire study (16 weeks per participant)
|
|
Social circumstances
Inpatient hospitalization
|
0.00%
0/15 • Collected over the course of the entire study (16 weeks per participant)
|
6.2%
1/16 • Number of events 1 • Collected over the course of the entire study (16 weeks per participant)
|
|
General disorders
Inpatient hospitalization
|
6.7%
1/15 • Number of events 1 • Collected over the course of the entire study (16 weeks per participant)
|
0.00%
0/16 • Collected over the course of the entire study (16 weeks per participant)
|
Other adverse events
| Measure |
Behavioral Activation Plus Exercise
n=15 participants at risk
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.
|
Behavioral Activation Plus Stretching
n=16 participants at risk
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.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Sprained ankle
|
6.7%
1/15 • Number of events 1 • Collected over the course of the entire study (16 weeks per participant)
|
0.00%
0/16 • Collected over the course of the entire study (16 weeks per participant)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/15 • Collected over the course of the entire study (16 weeks per participant)
|
12.5%
2/16 • Number of events 5 • Collected over the course of the entire study (16 weeks per participant)
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/15 • Collected over the course of the entire study (16 weeks per participant)
|
6.2%
1/16 • Number of events 1 • Collected over the course of the entire study (16 weeks per participant)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place