Trial Outcomes & Findings for Building Recovery By Improving Goals, Habits, and Thoughts (NCT NCT01191788)
NCT ID: NCT01191788
Last Updated: 2022-10-18
Results Overview
The Beck Depression Inventory II (BDI-II) is a 21 question, self-administered measure of depressive symptoms. Scores range from 0 - 63, with higher scores indicating more severe depressive symptoms.
COMPLETED
NA
299 participants
3 Months Post Treatment
2022-10-18
Participant Flow
Participant milestones
| Measure |
Group CBT
Clients received up to 16 sessions of group CBT for depression
|
Comparison
Treatment as Usual comparison condition
|
|---|---|---|
|
Overall Study
STARTED
|
140
|
159
|
|
Overall Study
COMPLETED
|
119
|
137
|
|
Overall Study
NOT COMPLETED
|
21
|
22
|
Reasons for withdrawal
| Measure |
Group CBT
Clients received up to 16 sessions of group CBT for depression
|
Comparison
Treatment as Usual comparison condition
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
21
|
22
|
Baseline Characteristics
Building Recovery By Improving Goals, Habits, and Thoughts
Baseline characteristics by cohort
| Measure |
Group CBT
n=140 Participants
Clients received up to 16 sessions of group CBT for depression
|
Comparison
n=159 Participants
Treatment as Usual comparison condition
|
Total
n=299 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
139 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
298 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
|
35.31 years
STANDARD_DEVIATION 10.08 • n=5 Participants
|
37.04 years
STANDARD_DEVIATION 10.53 • n=7 Participants
|
36.23 years
STANDARD_DEVIATION 10.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
140 participants
n=5 Participants
|
159 participants
n=7 Participants
|
299 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 Months Post TreatmentThe Beck Depression Inventory II (BDI-II) is a 21 question, self-administered measure of depressive symptoms. Scores range from 0 - 63, with higher scores indicating more severe depressive symptoms.
Outcome measures
| Measure |
Group CBT
n=120 Participants
Usual care + BRIGHT intervention. The BRIGHT intervention included 16 two-hour group sessions of CBT for depression.
|
Comparison
n=140 Participants
Usual care
|
|---|---|---|
|
Depressive Symptoms as Measured by the Beck Depression Inventory II
|
14.83 BDI-II score
Standard Deviation 11.23
|
21.82 BDI-II score
Standard Deviation 12.74
|
SECONDARY outcome
Timeframe: 3 Months Post TreatmentThe SF-12 is a 12 question, self-administered measure of general health functioning. The SF-12 outputs a mental health summary score (MCS), which ranges from 0 to 100, with higher scores indicating better mental health functioning. MCS scores are standardized such that mean = 50 and SD = 10 in the general U.S. population.
Outcome measures
| Measure |
Group CBT
n=120 Participants
Usual care + BRIGHT intervention. The BRIGHT intervention included 16 two-hour group sessions of CBT for depression.
|
Comparison
n=140 Participants
Usual care
|
|---|---|---|
|
Mental Health Functioning as Measured by SF-12 MCS.
|
44.71 SF-12 score
Standard Deviation 11.34
|
38.44 SF-12 score
Standard Deviation 11.89
|
Adverse Events
Group CBT
Comparison
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place