Trial Outcomes & Findings for Effectiveness and Implementation of Brief Cognitive Behavioral Therapy in CBOCs (NCT NCT02466126)
NCT ID: NCT02466126
Last Updated: 2023-07-27
Results Overview
The PHQ-9 is used to measure a person's level of depression. Scores on the measure can range from 0 to 27. The higher the score the higher level of depression someone is experiencing.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
189 participants
Primary outcome timeframe
Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.
Results posted on
2023-07-27
Participant Flow
Participant milestones
| Measure |
bCBT/Direct Referral
A brief cognitive behavioral therapy intervention that offers 6 active- treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to maintain changes.
bCBT: The bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to solidify changes. All participants receive an initial (core) session. In this session, participants work with their study clinician to set goals that are not restricted to "emotional health" (e.g., depression) but may also address "physical health" concerns (e.g., diet, exercise, managing a chronic condition). Following the core session, clinicians provide participants with a series of module choices, from which they select skills that match their most pressing needs. Each module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced and customized to the patient's immediate goals, regardless of the focus (physical or mental health).
|
Enhanced Usual Care (EUC)
Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers.
|
|---|---|---|
|
Baseline
STARTED
|
109
|
80
|
|
Baseline
COMPLETED
|
109
|
80
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
4 Month Assessment
STARTED
|
109
|
80
|
|
4 Month Assessment
COMPLETED
|
93
|
71
|
|
4 Month Assessment
NOT COMPLETED
|
16
|
9
|
|
8 Month Assessment
STARTED
|
93
|
71
|
|
8 Month Assessment
COMPLETED
|
86
|
68
|
|
8 Month Assessment
NOT COMPLETED
|
7
|
3
|
|
12 Month Assessment
STARTED
|
86
|
68
|
|
12 Month Assessment
COMPLETED
|
85
|
66
|
|
12 Month Assessment
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The number of participants completing the assessment differs because some items were not completed by participants. If a participant didn't complete all of the items, then data was not used in the calculations.
Baseline characteristics by cohort
| Measure |
bCBT/Direct Referral
n=109 Participants
A brief cognitive behavioral therapy intervention that offers 6 active- treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to maintain changes.
bCBT: The bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to solidify changes. All participants receive an initial (core) session. In this session, participants work with their study clinician to set goals that are not restricted to "emotional health" (e.g., depression) but may also address "physical health" concerns (e.g., diet, exercise, managing a chronic condition). Following the core session, clinicians provide participants with a series of module choices, from which they select skills that match their most pressing needs. Each module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced and customized to the patient's immediate goals, regardless of the focus (physical or mental health).
|
Enhanced Usual Care (EUC)
n=80 Participants
Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers.
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 13.3 • n=109 Participants
|
56.9 years
STANDARD_DEVIATION 13.8 • n=80 Participants
|
58.3 years
STANDARD_DEVIATION 13.4 • n=189 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=109 Participants
|
11 Participants
n=80 Participants
|
18 Participants
n=189 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=109 Participants
|
69 Participants
n=80 Participants
|
171 Participants
n=189 Participants
|
|
Race/Ethnicity, Customized
White
|
68 Participants
n=109 Participants
|
55 Participants
n=80 Participants
|
123 Participants
n=189 Participants
|
|
Race/Ethnicity, Customized
African American
|
19 Participants
n=109 Participants
|
11 Participants
n=80 Participants
|
30 Participants
n=189 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
6 Participants
n=109 Participants
|
1 Participants
n=80 Participants
|
7 Participants
n=189 Participants
|
|
Race/Ethnicity, Customized
Asian/Vietnamese
|
1 Participants
n=109 Participants
|
1 Participants
n=80 Participants
|
2 Participants
n=189 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
11 Participants
n=109 Participants
|
8 Participants
n=80 Participants
|
19 Participants
n=189 Participants
|
|
Race/Ethnicity, Customized
Multiple Race
|
4 Participants
n=109 Participants
|
3 Participants
n=80 Participants
|
7 Participants
n=189 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=109 Participants
|
1 Participants
n=80 Participants
|
1 Participants
n=189 Participants
|
|
PHQ-9
Moderate (10-14)
|
37 Participants
n=109 Participants
|
32 Participants
n=80 Participants
|
69 Participants
n=189 Participants
|
|
PHQ-9
Moderate severe (15-19)
|
47 Participants
n=109 Participants
|
28 Participants
n=80 Participants
|
75 Participants
n=189 Participants
|
|
PHQ-9
Severe (20-27)
|
25 Participants
n=109 Participants
|
20 Participants
n=80 Participants
|
45 Participants
n=189 Participants
|
|
SF-12
SF - 12 PCS
|
33.12 units on a scale
STANDARD_DEVIATION 11.54 • n=106 Participants • The number of participants completing the assessment differs because some items were not completed by participants. If a participant didn't complete all of the items, then data was not used in the calculations.
|
34.59 units on a scale
STANDARD_DEVIATION 13.12 • n=77 Participants • The number of participants completing the assessment differs because some items were not completed by participants. If a participant didn't complete all of the items, then data was not used in the calculations.
|
33.74 units on a scale
STANDARD_DEVIATION 12.21 • n=183 Participants • The number of participants completing the assessment differs because some items were not completed by participants. If a participant didn't complete all of the items, then data was not used in the calculations.
|
|
SF-12
SF - 12 MCS
|
37.17 units on a scale
STANDARD_DEVIATION 9.79 • n=106 Participants • The number of participants completing the assessment differs because some items were not completed by participants. If a participant didn't complete all of the items, then data was not used in the calculations.
|
34.43 units on a scale
STANDARD_DEVIATION 10.31 • n=77 Participants • The number of participants completing the assessment differs because some items were not completed by participants. If a participant didn't complete all of the items, then data was not used in the calculations.
|
36.02 units on a scale
STANDARD_DEVIATION 10.07 • n=183 Participants • The number of participants completing the assessment differs because some items were not completed by participants. If a participant didn't complete all of the items, then data was not used in the calculations.
|
|
Beck Depression Inventory (BDI)
|
25.65 units on a scale
STANDARD_DEVIATION 7.47 • n=99 Participants • The number of participants completing the assessment differs because some items were not completed by participants. If a participant didn't complete all of the items, then data was not used in the calculations.
|
26.34 units on a scale
STANDARD_DEVIATION 8.33 • n=68 Participants • The number of participants completing the assessment differs because some items were not completed by participants. If a participant didn't complete all of the items, then data was not used in the calculations.
|
25.93 units on a scale
STANDARD_DEVIATION 7.81 • n=167 Participants • The number of participants completing the assessment differs because some items were not completed by participants. If a participant didn't complete all of the items, then data was not used in the calculations.
|
PRIMARY outcome
Timeframe: Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.Population: The overall number of participants for each group was contacted to complete follow up assessments. Some participants declined to complete the assessment at each time point. Reasons for not completing assessments included: participants not interested in completing, unable to contact, and withdrew from the study. The population analyzed during the follow-up period represents the participants that agreed to complete the assessments for that time period.
The PHQ-9 is used to measure a person's level of depression. Scores on the measure can range from 0 to 27. The higher the score the higher level of depression someone is experiencing.
Outcome measures
| Measure |
bCBT/Direct Referral
n=109 Participants
A brief cognitive behavioral therapy intervention that offers 6 active- treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to maintain changes.
bCBT: The bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to solidify changes. All participants receive an initial (core) session. In this session, participants work with their study clinician to set goals that are not restricted to "emotional health" (e.g., depression) but may also address "physical health" concerns (e.g., diet, exercise, managing a chronic condition). Following the core session, clinicians provide participants with a series of module choices, from which they select skills that match their most pressing needs. Each module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced and customized to the patient's immediate goals, regardless of the focus (physical or mental health).
|
Enhanced Usual Care (EUC)
n=80 Participants
Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers.
|
|---|---|---|
|
Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline.
Baseline
|
16.40 score on a scale
Standard Deviation 3.75
|
16.34 score on a scale
Standard Deviation 4.24
|
|
Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline.
4 Month
|
11.74 score on a scale
Standard Deviation 5.76
|
14.94 score on a scale
Standard Deviation 5.51
|
|
Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline.
8 Month
|
12.79 score on a scale
Standard Deviation 5.03
|
14.74 score on a scale
Standard Deviation 5.67
|
|
Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline.
12 Month
|
12.99 score on a scale
Standard Deviation 5.08
|
14.14 score on a scale
Standard Deviation 5.40
|
SECONDARY outcome
Timeframe: Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.Population: The overall number of participants for each group was contacted to complete follow up assessments. Some participants declined to complete the assessment at each time point. Reasons for not completing assessments included: participants not interested in completing, unable to contact, and withdrew from the study. The population analyzed during the follow-up period represents the participants that agreed to complete the assessments for that time period.
The measure will be used a s a second assessment to measure depression. Scores on the measure can range from 0 to 63. The higher the score the higher level of depression someone is experiencing.
Outcome measures
| Measure |
bCBT/Direct Referral
n=99 Participants
A brief cognitive behavioral therapy intervention that offers 6 active- treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to maintain changes.
bCBT: The bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to solidify changes. All participants receive an initial (core) session. In this session, participants work with their study clinician to set goals that are not restricted to "emotional health" (e.g., depression) but may also address "physical health" concerns (e.g., diet, exercise, managing a chronic condition). Following the core session, clinicians provide participants with a series of module choices, from which they select skills that match their most pressing needs. Each module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced and customized to the patient's immediate goals, regardless of the focus (physical or mental health).
|
Enhanced Usual Care (EUC)
n=68 Participants
Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers.
|
|---|---|---|
|
Beck Depression Inventory (BDI) - Change is Being Assessed Using a 4 Timepoint Process
Baseline
|
25.65 score on a scale
Standard Deviation 7.47
|
26.34 score on a scale
Standard Deviation 8.33
|
|
Beck Depression Inventory (BDI) - Change is Being Assessed Using a 4 Timepoint Process
4 Month
|
18.98 score on a scale
Standard Deviation 10.41
|
22.68 score on a scale
Standard Deviation 10.07
|
|
Beck Depression Inventory (BDI) - Change is Being Assessed Using a 4 Timepoint Process
8 Month
|
20.23 score on a scale
Standard Deviation 9.39
|
22.02 score on a scale
Standard Deviation 10.89
|
|
Beck Depression Inventory (BDI) - Change is Being Assessed Using a 4 Timepoint Process
12 Month
|
20.72 score on a scale
Standard Deviation 9.38
|
22.86 score on a scale
Standard Deviation 10.99
|
SECONDARY outcome
Timeframe: Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.Population: The overall number of participants for each group was contacted to complete follow up assessments. Some participants declined to complete the assessment at each time point. Reasons for not completing assessments included: participants not interested in completing, unable to contact, and withdrew from the study. The population analyzed during the follow-up period represents the participants that agreed to complete the assessments for that time period.
SF-12 will be used to measure a participant's functional status. The SF-12V measures 8 concepts of health and can be summarized into summary component scores for physical (PCS) and mental (MCS) functioning. Scores can range from 0 - 100 and higher scores mean better functioning and quality of life.
Outcome measures
| Measure |
bCBT/Direct Referral
n=106 Participants
A brief cognitive behavioral therapy intervention that offers 6 active- treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to maintain changes.
bCBT: The bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to solidify changes. All participants receive an initial (core) session. In this session, participants work with their study clinician to set goals that are not restricted to "emotional health" (e.g., depression) but may also address "physical health" concerns (e.g., diet, exercise, managing a chronic condition). Following the core session, clinicians provide participants with a series of module choices, from which they select skills that match their most pressing needs. Each module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced and customized to the patient's immediate goals, regardless of the focus (physical or mental health).
|
Enhanced Usual Care (EUC)
n=77 Participants
Participants are provided with educational information on depression and will be encouraged to seek additional depression care options through their primary care providers.
|
|---|---|---|
|
Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process
Baseline: Physical Health
|
33.12 score on a scale
Standard Deviation 11.54
|
34.59 score on a scale
Standard Deviation 13.12
|
|
Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process
Baseline: Mental Health
|
37.17 score on a scale
Standard Deviation 9.79
|
34.43 score on a scale
Standard Deviation 10.31
|
|
Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process
4 Month: Physical Health
|
31.46 score on a scale
Standard Deviation 10.05
|
32.83 score on a scale
Standard Deviation 12.21
|
|
Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process
4 Month: Mental Health
|
41.84 score on a scale
Standard Deviation 12.58
|
36.82 score on a scale
Standard Deviation 10.03
|
|
Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process
8 Month: Physical Health
|
29.72 score on a scale
Standard Deviation 10.25
|
31.66 score on a scale
Standard Deviation 12.05
|
|
Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process
8 Month: Mental Health
|
39.76 score on a scale
Standard Deviation 11.38
|
35.44 score on a scale
Standard Deviation 11.37
|
|
Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process
12 Month: Physical Health
|
30.98 score on a scale
Standard Deviation 10.91
|
31.01 score on a scale
Standard Deviation 11.87
|
|
Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process
12 Month: Mental Health
|
38.41 score on a scale
Standard Deviation 10.89
|
36.13 score on a scale
Standard Deviation 11.27
|
Adverse Events
bCBT/Direct Referral
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Usual Care (EUC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jeffrey Cully
Department of Veterans Affairs, Micheal E. DeBakey VAMC
Phone: 713-794-8526
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place