Depression
Conditions
Keywords
Depression, brief Cognitive Behavioral Therapy (bCBT), Randomized Controlled Trial
Brief summary
The purpose of this study is to determine the effectiveness of a brief cognitive behavioral therapy (bCBT) intervention for Veterans with depression delivered by mental health providers located at VA Community Based Outpatient Clinics (CBOC's) associated with the Houston and Oklahoma City VAMCs.
Detailed description
Depression is a serious health condition that places tremendous burden on patients and healthcare systems and is especially prevalent in Veterans. In 2008, the VHA released the Uniform Mental Health Services Handbook (Handbook 1160.01) in an effort to expand services for Veterans with depression, including those in primary care and CBOC settings. The VA remains a national leader in mental health services, but the provision of psychotherapy within VA is limited, especially for rural Veterans and those cared for in CBOCs. The VA has invested significant resources to improve access to high-quality mental health care, including a rapid expansion into CBOCs. Currently, there is a need to work with clinicians and stakeholders to address practice barriers related to mental health practices in CBOCs. A recent survey of 4,200 mental health providers in VA found that, although robust expansion and improved quality of mental health care services has occurred, access to proven effective psychotherapies in CBOCs remains a focused area for improvement. The study will examine whether existing VA CBOC mental health clinicians, with training and support, can effectively administer a structured brief cognitive behavioral therapy (bCBT) intervention for Veterans with clinically elevated symptoms of depression.
Interventions
BEHAVIORALbCBT
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).
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* must have clinically significant symptoms of depression; * must be current recipients of services at CBOCs associated with the Houston and Oklahoma City VAMCs.
Exclusion criteria
* cognitive impairment; * presence of bipolar, psychotic or substance-abuse disorders. * Veterans currently receiving psychotherapy WILL be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline. | Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory (BDI) - Change is Being Assessed Using a 4 Timepoint Process | Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up. | 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. |
| Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process | Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 109 |
| 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. | 80 |
| Total | 189 |
Baseline characteristics
| Characteristic | Total | Enhanced Usual Care (EUC) | bCBT/Direct Referral |
|---|---|---|---|
| Age, Continuous | 58.3 years STANDARD_DEVIATION 13.4 | 56.9 years STANDARD_DEVIATION 13.8 | 59.1 years STANDARD_DEVIATION 13.3 |
| Beck Depression Inventory (BDI) | 25.93 units on a scale STANDARD_DEVIATION 7.81 | 26.34 units on a scale STANDARD_DEVIATION 8.33 | 25.65 units on a scale STANDARD_DEVIATION 7.47 |
| PHQ-9 Moderate (10-14) | 69 Participants | 32 Participants | 37 Participants |
| PHQ-9 Moderate severe (15-19) | 75 Participants | 28 Participants | 47 Participants |
| PHQ-9 Severe (20-27) | 45 Participants | 20 Participants | 25 Participants |
| Race/Ethnicity, Customized African American | 30 Participants | 11 Participants | 19 Participants |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 7 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian/Vietnamese | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 19 Participants | 8 Participants | 11 Participants |
| Race/Ethnicity, Customized Multiple Race | 7 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 123 Participants | 55 Participants | 68 Participants |
| Sex: Female, Male Female | 18 Participants | 11 Participants | 7 Participants |
| Sex: Female, Male Male | 171 Participants | 69 Participants | 102 Participants |
| SF-12 SF - 12 MCS | 36.02 units on a scale STANDARD_DEVIATION 10.07 | 34.43 units on a scale STANDARD_DEVIATION 10.31 | 37.17 units on a scale STANDARD_DEVIATION 9.79 |
| SF-12 SF - 12 PCS | 33.74 units on a scale STANDARD_DEVIATION 12.21 | 34.59 units on a scale STANDARD_DEVIATION 13.12 | 33.12 units on a scale STANDARD_DEVIATION 11.54 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 109 | 0 / 80 |
| other Total, other adverse events | 0 / 109 | 0 / 80 |
| serious Total, serious adverse events | 0 / 109 | 0 / 80 |
Outcome results
Primary
Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| bCBT/Direct Referral | 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 |
| bCBT/Direct Referral | 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 |
| bCBT/Direct Referral | 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 |
| bCBT/Direct Referral | 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 |
| Enhanced Usual Care (EUC) | Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline. | 12 Month | 14.14 score on a scale | Standard Deviation 5.4 |
| Enhanced Usual Care (EUC) | Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline. | Baseline | 16.34 score on a scale | Standard Deviation 4.24 |
| Enhanced Usual Care (EUC) | Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline. | 8 Month | 14.74 score on a scale | Standard Deviation 5.67 |
| Enhanced Usual Care (EUC) | Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline. | 4 Month | 14.94 score on a scale | Standard Deviation 5.51 |
Secondary
Beck Depression Inventory (BDI) - Change is Being Assessed Using a 4 Timepoint Process
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| bCBT/Direct Referral | Beck Depression Inventory (BDI) - Change is Being Assessed Using a 4 Timepoint Process | Baseline | 25.65 score on a scale | Standard Deviation 7.47 |
| bCBT/Direct Referral | 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 |
| bCBT/Direct Referral | 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 |
| bCBT/Direct Referral | 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 |
| Enhanced Usual Care (EUC) | Beck Depression Inventory (BDI) - Change is Being Assessed Using a 4 Timepoint Process | 12 Month | 22.86 score on a scale | Standard Deviation 10.99 |
| Enhanced Usual Care (EUC) | Beck Depression Inventory (BDI) - Change is Being Assessed Using a 4 Timepoint Process | Baseline | 26.34 score on a scale | Standard Deviation 8.33 |
| Enhanced Usual Care (EUC) | Beck Depression Inventory (BDI) - Change is Being Assessed Using a 4 Timepoint Process | 8 Month | 22.02 score on a scale | Standard Deviation 10.89 |
| Enhanced Usual Care (EUC) | Beck Depression Inventory (BDI) - Change is Being Assessed Using a 4 Timepoint Process | 4 Month | 22.68 score on a scale | Standard Deviation 10.07 |
Secondary
Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| bCBT/Direct Referral | 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 |
| bCBT/Direct Referral | 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 |
| bCBT/Direct Referral | 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 |
| bCBT/Direct Referral | 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 |
| bCBT/Direct Referral | 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 |
| bCBT/Direct Referral | 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 |
| bCBT/Direct Referral | 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 |
| bCBT/Direct Referral | 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 |
| Enhanced Usual Care (EUC) | Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process | 12 Month: Mental Health | 36.13 score on a scale | Standard Deviation 11.27 |
| Enhanced Usual Care (EUC) | Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process | Baseline: Physical Health | 34.59 score on a scale | Standard Deviation 13.12 |
| Enhanced Usual Care (EUC) | Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process | 8 Month: Physical Health | 31.66 score on a scale | Standard Deviation 12.05 |
| Enhanced Usual Care (EUC) | Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process | Baseline: Mental Health | 34.43 score on a scale | Standard Deviation 10.31 |
| Enhanced Usual Care (EUC) | Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process | 12 Month: Physical Health | 31.01 score on a scale | Standard Deviation 11.87 |
| Enhanced Usual Care (EUC) | Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process | 4 Month: Physical Health | 32.83 score on a scale | Standard Deviation 12.21 |
| Enhanced Usual Care (EUC) | Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process | 8 Month: Mental Health | 35.44 score on a scale | Standard Deviation 11.37 |
| Enhanced Usual Care (EUC) | Health Survey for Veterans (SF-12) - Change is Being Assessed Using a 4 Timepoint Process | 4 Month: Mental Health | 36.82 score on a scale | Standard Deviation 10.03 |