Depression, Depressive Disorder
Conditions
Keywords
Cognitive-Behavioral Therapy, Telephone psychotherapy, Clinical Trial, Primary Care Clinic, Treatment for Depression
Brief summary
The purpose of this study is to examine the efficacy of telephone-administered cognitive-behavioral therapy (T-CBT) in treating major depression among veterans served by community-based outpatient clinics (CBOCs) in the Veteran's Integrated Service Network (VISN) 21, which serves rural areas in Northern California and (VISN) 12, which serves rural areas surrounding the Hines, IL VA Hospital.
Detailed description
More than 20% of patients in primary care have depressive disorders. While primary care is the principal venue for treatment for depression, fewer than 25% of depressed patients receive adequate treatment for their depression. These outcomes can be worse when there are barriers to treatment such as living in a rural area. Several studies have found that given a choice, about two-thirds of depressed primary care patients prefer psychotherapy or counseling over antidepressant medication. This is a controlled, randomized trial in which subjects meeting criteria for major depressive disorder (MDD) from primary care settings in VISN 21 including CBOCs will be randomly assigned to one of two conditions: 1) a 16-session manualized telephone administered cognitive behavioral therapy (T-CBT) delivered over 20 weeks or 2) a treatment-as-usual (TAU) condition. Telephone-administered cognitive behavioral therapy (T-CBT) is an intervention aimed at improving coping skills and social functioning. It is divided into two phases: 1) an initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and 2) a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains. T-CBT, administered by doctoral level psychologists, will be compared to a treatment-as-usual (TAU) condition that controls for the natural course of depression during the course of treatment.
Interventions
BEHAVIORALTelephone cognitive behavioral therapy
An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.
Sponsors
US Department of Veterans Affairs
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
* Has a DSM-IV diagnosis of Major Depressive Disorder as assessed using the MINI * Has a telephone * Able to speak and read English * At least 18 years of age * Able to give informed consent * Must be registered at a VA community-based, outpatient clinic (CBOC) at VA Eureka or VA Ukiah or VA Santa Rosa, or VA Manteno, or VA Elgin, or VA La Salle
Exclusion criteria
* Has a hearing, voice or visual impairment that would prevent participation in T-CBT * Meets criteria for dementia * Is diagnosed with Psychotic Disorder, Bipolar Disorder, substance abuse with clinical consensus, or current severe PTSD. * Is currently receiving psychotherapy or planning to receive psychotherapy during the 20-week treatment phase of the study * Has a history of suicide attempts or is at high risk for suicide.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Severity of Depression Using Hamilton Depression Rating Scale | Baseline, 12 weeks, 20 weeks | Evaluators administered the Hamilton Depression Rating Scale(Ham-D). Veterans were assessed at baseline,12 weeks, 20 weeks(posttreatment), and 6-month follow-up using the Ham-D. Self-reported depression was measured using the Hamilton Depression Rating Scale(Ham-D). Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D. Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression. |
| Change in Severity of Depression Using the Patient Health Questionnaire-9 | Baseline, Week 12, Week 20 | Self-reported depression was measured using the Patient Health Questionnaire-9 (PHQ-9). Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome PHQ-9. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression, respectively. PHQ-9 score ranges from 0-27, higher values indicate more severe depression. |
| Number of Participants Meeting Criteria for Major Depressive Disorder | Baseline to week 12, and week 20 | Veterans meeting criteria for major depressive disorder were randomized to receive 16 session of T-CBT over 20 weeks or treatment as usual through the CBOC. Generalized estimating equations models with exchangeable working correlation structure was used for the binary outcome (MDE). A veteran was required to meet diagnostic criteria for severe psychiatric disorder(e.g., psychotic, bipolar, or dementia disorder; post-traumatic stress disorder \[PTSD\] patients were not excluded). DSM-IV diagnosis was assessed using the full Mini International Neuropsychiatric Interview at baseline, whereas the major depressive episode(MDE) module was administered at follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of Treatment Effect | 6 month follow-up (week 44) | Evaluators administered the Hamilton Depression Rating Scale(Ham-D). Veterans were assessed at baseline,12 weeks, 20 weeks(post treatment), and 6-month follow-up using the Ham-D.Data was analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D. Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression. |
| Number of Participants Meeting Criteria for Major Depression Disorder at 6 Month Follow-up | 6-month follow up at week 44 post treatment | Veterans meeting criteria for major depressive disorder were randomized to receive 16 session of T-CBT over 20 weeks or treatment as usual through the CBOC. Generalized estimating equations models with exchangeable working correlation structure was used for the binary outcome (MDE). A veteran was required to meet diagnostic criteria for severe psychiatric disorder(e.g., psychotic, bipolar, or dementia disorder; post-traumatic stress disorder \[PTSD\] patients were not excluded). DSM-IV diagnosis was assessed using the full Mini International Neuropsychiatric Interview at baseline, whereas the major depressive episode(MDE) module was administered at follow-up. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telephone-administered Cognitive-Behavioral Therapy Telephone cognitive behavioral therapy
Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains. | 41 |
| Treatment as Usual Treatment as usual control. | 44 |
| Total | 85 |
Baseline characteristics
| Characteristic | Telephone-administered Cognitive-Behavioral Therapy | Total | Treatment as Usual |
|---|---|---|---|
| Age, Continuous | 56.83 years STANDARD_DEVIATION 10.81 | 55.9 years STANDARD_DEVIATION 10.59 | 54.98 years STANDARD_DEVIATION 10.42 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 18 Participants | 10 Participants |
| Race (NIH/OMB) White | 33 Participants | 67 Participants | 34 Participants |
| Region of Enrollment United States | 41 participants | 85 participants | 44 participants |
| Sex: Female, Male Female | 3 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Male | 38 Participants | 77 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 41 | 0 / 44 |
| serious Total, serious adverse events | 0 / 41 | 0 / 44 |
Outcome results
Primary
Change in Severity of Depression Using Hamilton Depression Rating Scale
Evaluators administered the Hamilton Depression Rating Scale(Ham-D). Veterans were assessed at baseline,12 weeks, 20 weeks(posttreatment), and 6-month follow-up using the Ham-D. Self-reported depression was measured using the Hamilton Depression Rating Scale(Ham-D). Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D. Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.
Time frame: Baseline, 12 weeks, 20 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telephone-administered Cognitive-Behavioral Therapy | Change in Severity of Depression Using Hamilton Depression Rating Scale | Baseline, n = 41, n = 44, respectively | 20.83 units on a scale | Standard Deviation 3.96 |
| Telephone-administered Cognitive-Behavioral Therapy | Change in Severity of Depression Using Hamilton Depression Rating Scale | Week 12, n = 40, n = 41 respectively | 16.71 units on a scale | Standard Deviation 6.42 |
| Telephone-administered Cognitive-Behavioral Therapy | Change in Severity of Depression Using Hamilton Depression Rating Scale | Week 20, n = 40, n =41, respectively | 15.43 units on a scale | Standard Deviation 5.51 |
| Treatment as Usual | Change in Severity of Depression Using Hamilton Depression Rating Scale | Baseline, n = 41, n = 44, respectively | 19.23 units on a scale | Standard Deviation 3.72 |
| Treatment as Usual | Change in Severity of Depression Using Hamilton Depression Rating Scale | Week 12, n = 40, n = 41 respectively | 17.27 units on a scale | Standard Deviation 5.29 |
| Treatment as Usual | Change in Severity of Depression Using Hamilton Depression Rating Scale | Week 20, n = 40, n =41, respectively | 17.00 units on a scale | Standard Deviation 5.68 |
p-value: =0.001Mixed Models Analysis
p-value: 0.07Mixed Models Analysis
p-value: 0.95Mixed Models Analysis
Primary
Change in Severity of Depression Using the Patient Health Questionnaire-9
Self-reported depression was measured using the Patient Health Questionnaire-9 (PHQ-9). Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome PHQ-9. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression, respectively. PHQ-9 score ranges from 0-27, higher values indicate more severe depression.
Time frame: Baseline, Week 12, Week 20
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telephone-administered Cognitive-Behavioral Therapy | Change in Severity of Depression Using the Patient Health Questionnaire-9 | Baseline, n = 41, n = 44, respectively | 17.12 units on a scale | Standard Deviation 5.1 |
| Telephone-administered Cognitive-Behavioral Therapy | Change in Severity of Depression Using the Patient Health Questionnaire-9 | Week 12, n = 40, n = 41, respectively | 12.19 units on a scale | Standard Deviation 5.96 |
| Telephone-administered Cognitive-Behavioral Therapy | Change in Severity of Depression Using the Patient Health Questionnaire-9 | Week 20, n = 40, n = 41, respectively | 11.15 units on a scale | Standard Deviation 6.46 |
| Treatment as Usual | Change in Severity of Depression Using the Patient Health Questionnaire-9 | Baseline, n = 41, n = 44, respectively | 17.39 units on a scale | Standard Deviation 4.79 |
| Treatment as Usual | Change in Severity of Depression Using the Patient Health Questionnaire-9 | Week 12, n = 40, n = 41, respectively | 14.35 units on a scale | Standard Deviation 6.05 |
| Treatment as Usual | Change in Severity of Depression Using the Patient Health Questionnaire-9 | Week 20, n = 40, n = 41, respectively | 12.90 units on a scale | Standard Deviation 5.28 |
p-value: <0.0001Mixed Models Analysis
p-value: 0.61Mixed Models Analysis
p-value: 0.2Mixed Models Analysis
Primary
Number of Participants Meeting Criteria for Major Depressive Disorder
Veterans meeting criteria for major depressive disorder were randomized to receive 16 session of T-CBT over 20 weeks or treatment as usual through the CBOC. Generalized estimating equations models with exchangeable working correlation structure was used for the binary outcome (MDE). A veteran was required to meet diagnostic criteria for severe psychiatric disorder(e.g., psychotic, bipolar, or dementia disorder; post-traumatic stress disorder \[PTSD\] patients were not excluded). DSM-IV diagnosis was assessed using the full Mini International Neuropsychiatric Interview at baseline, whereas the major depressive episode(MDE) module was administered at follow-up.
Time frame: Baseline to week 12, and week 20
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telephone-administered Cognitive-Behavioral Therapy | Number of Participants Meeting Criteria for Major Depressive Disorder | number of particpants with MDE at Baseline | 41 participants |
| Telephone-administered Cognitive-Behavioral Therapy | Number of Participants Meeting Criteria for Major Depressive Disorder | number of particpants with MDE Week 12 | 20 participants |
| Telephone-administered Cognitive-Behavioral Therapy | Number of Participants Meeting Criteria for Major Depressive Disorder | number of particpants with MDE Week 20 | 19 participants |
| Treatment as Usual | Number of Participants Meeting Criteria for Major Depressive Disorder | number of particpants with MDE at Baseline | 44 participants |
| Treatment as Usual | Number of Participants Meeting Criteria for Major Depressive Disorder | number of particpants with MDE Week 12 | 29 participants |
| Treatment as Usual | Number of Participants Meeting Criteria for Major Depressive Disorder | number of particpants with MDE Week 20 | 23 participants |
p-value: <0.0001Generalized estimating equations models
p-value: 0.12Generalized estimating equations models
p-value: 0.86Generalized estimating equations models
Secondary
Maintenance of Treatment Effect
Evaluators administered the Hamilton Depression Rating Scale(Ham-D). Veterans were assessed at baseline,12 weeks, 20 weeks(post treatment), and 6-month follow-up using the Ham-D.Data was analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D. Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.
Time frame: 6 month follow-up (week 44)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telephone-administered Cognitive-Behavioral Therapy | Maintenance of Treatment Effect | 13.62 units on a scale | Standard Deviation 6.36 |
| Treatment as Usual | Maintenance of Treatment Effect | 14.81 units on a scale | Standard Deviation 5.01 |
p-value: >0.37Mixed Models Analysis
Secondary
Maintenance of Treatment Effect
6-month post treatment follow-up on outcome measure of the Patient Health Questionnaire-9 (PHQ-9). Data was analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome PHQ-9. PHQ-9 score ranges from 0-27, higher values indicate more severe depression. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression, respectively.
Time frame: 6-month post treatment follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telephone-administered Cognitive-Behavioral Therapy | Maintenance of Treatment Effect | 11.25 units on a scale | Standard Deviation 6.67 |
| Treatment as Usual | Maintenance of Treatment Effect | 12.26 units on a scale | Standard Deviation 5.63 |
p-value: >0.37Mixed Models Analysis
Secondary
Number of Participants Meeting Criteria for Major Depression Disorder at 6 Month Follow-up
Veterans meeting criteria for major depressive disorder were randomized to receive 16 session of T-CBT over 20 weeks or treatment as usual through the CBOC. Generalized estimating equations models with exchangeable working correlation structure was used for the binary outcome (MDE). A veteran was required to meet diagnostic criteria for severe psychiatric disorder(e.g., psychotic, bipolar, or dementia disorder; post-traumatic stress disorder \[PTSD\] patients were not excluded). DSM-IV diagnosis was assessed using the full Mini International Neuropsychiatric Interview at baseline, whereas the major depressive episode(MDE) module was administered at follow-up.
Time frame: 6-month follow up at week 44 post treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telephone-administered Cognitive-Behavioral Therapy | Number of Participants Meeting Criteria for Major Depression Disorder at 6 Month Follow-up | 16 participants |
| Treatment as Usual | Number of Participants Meeting Criteria for Major Depression Disorder at 6 Month Follow-up | 18 participants |
p-value: >0.37Generalized estimating equations models