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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH095753-01A1 | U.S. NIH Grant/Contract | View source |
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This is a randomized, controlled trial comparing telephone-cognitive behavior therapy (T-CBT) with a therapist to a "Stepped Care" intervention for depression treatment (iCBT with support from a telephone coach with the possibility of being stepped up to receiving T-CBT with a therapist).
Major depressive disorder (MDD) is common, with 12-month prevalence rates estimated to be between 6.6-10.3%. While many depressed patients state they would prefer psychological treatment to pharmacotherapy, substantial barriers to care exist, including cost, practical barriers such as time constraints and transportation, emotional barriers such as stigma, decreased motivation associated with depression itself, physical disability, and lack of availability of services. Telemental health has been proposed as a method of overcoming barriers to treatment. Research has focused primarily on two formats: the telephone and the Internet. Use of the telephone as a delivery medium produces reductions in depression equivalent to face-to-face psychological treatments, while also significantly reducing attrition. However, its success in outreach can also significantly increase costs for healthcare providing organizations. Internet interventions have the potential to produce moderate gains when supported by therapist or coach via brief telephone calls or e-mail but are also less expensive than standard therapy. Developing healthcare models that integrate treatment delivery media holds the promise of harnessing the advantages of each media, while minimizing the disadvantages. Stepped care models are a potentially useful framework for achieving such an integration. The stepped care model we will test initiates treatment with a validated, guided Internet cognitive behavioral therapy program. If patients fail to respond, they will be stepped up to a validated telephone-cognitive behavior therapy (T-CBT). The stepped care model will be compared to T-CBT in a randomized trial. Patients will be recruited from primary care and treated for up to 20 weeks, or until sustained remission is achieved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stepped Care | Experimental | Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist |
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| Telephone Cognitive Behavior Therapy | Active Comparator | Participants will receive telephone-administered cognitive behavioral therapy (T-CBT). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stepped Care | Behavioral | Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | To measure changes in the Quick Inventory of Depressive Symptomatology (QIDS) over time. The QIDS is made up of 16 items and has a possible range of scores of 0 to 27. Higher scores represent worse outcomes. | Baseline, midtreatment, end of treatment, 3 month post treatment, and 6 month post-treatment follow-up |
| Cost-Effectiveness | Measure the ratio of the difference in costs and difference in effectiveness between the two groups, Stepped care minus Telephone Cognitive Behavior Therapy. Below are reported individual cost means and standard deviations for therapist costs during study. | Baseline to end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David C Mohr, Ph.D. | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31634738 | Derived | Mohr DC, Lattie EG, Tomasino KN, Kwasny MJ, Kaiser SM, Gray EL, Alam N, Jordan N, Schueller SM. A randomized noninferiority trial evaluating remotely-delivered stepped care for depression using internet cognitive behavioral therapy (CBT) and telephone CBT. Behav Res Ther. 2019 Dec;123:103485. doi: 10.1016/j.brat.2019.103485. Epub 2019 Sep 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stepped Care | Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist Stepped Care: Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist |
| FG001 | Telephone Cognitive Behavior Therapy | Participants will receive telephone-administered cognitive behavioral therapy (T-CBT). Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Stepped Care | Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist Stepped Care: Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depression | To measure changes in the Quick Inventory of Depressive Symptomatology (QIDS) over time. The QIDS is made up of 16 items and has a possible range of scores of 0 to 27. Higher scores represent worse outcomes. | Participants with at least one followup visit which recorded the QIDS post baseline | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, midtreatment, end of treatment, 3 month post treatment, and 6 month post-treatment follow-up |
|
Baseline through 6 month post-treatment followup
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stepped Care | Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist Stepped Care: Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Kwasny | Northwestern University | 312-503-2294 | m-kwasny@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2017 | Feb 28, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Telephone Cognitive Behavior Therapy | Behavioral | Participants will receive telephone-administered cognitive behavioral therapy (T-CBT). |
|
| BG001 | Telephone Cognitive Behavior Therapy | Participants will receive telephone-administered cognitive behavioral therapy (T-CBT). Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Two patients did not report their gender. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Baseline QIDS (Quick Inventory of Depressive Symptomatology) | QIDS is made up of 16 items and has a possible range of scores of 0 to 27. Higher scores represent worse outcomes. | Median | Inter-Quartile Range | units on a scale |
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| PHQ-9 (Patient Health Questionnaire 9) | PHQ-9 is made up of 9 items and has a possible range of scores of 0 to 27. Higher scores represent worse outcomes. | Median | Inter-Quartile Range | units on a scale |
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| OG001 | Telephone Cognitive Behavior Therapy | Participants will receive telephone-administered cognitive behavioral therapy (T-CBT). Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT). |
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| Primary | Cost-Effectiveness | Measure the ratio of the difference in costs and difference in effectiveness between the two groups, Stepped care minus Telephone Cognitive Behavior Therapy. Below are reported individual cost means and standard deviations for therapist costs during study. | All randomized participants | Posted | Mean | Standard Deviation | dollars | Baseline to end of treatment |
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| 0 |
| 157 |
| 0 |
| 157 |
| 0 |
| 157 |
| EG001 | Telephone Cognitive Behavior Therapy | Participants will receive telephone-administered cognitive behavioral therapy (T-CBT). Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT). | 0 | 155 | 0 | 155 | 0 | 155 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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