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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH059708 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will compare the effectiveness of telephone versus face-to-face administration of cognitive behavioral therapy in treating people with depression.
Major depressive disorder is a common and often long-lasting disorder with 12-month prevalence rates estimated to be between 6.6% and 10.3%. Although the personal and societal costs of depression are high, it is well established that depression can be effectively treated using antidepressant medication and/or forms of psychotherapy. Several studies have found that when given a choice, about two-thirds of depressed patients prefer psychotherapy or counseling over antidepressant medication. However, a variety of barriers exist to initiating and maintaining psychotherapy. Only about 20% of all patients referred for psychotherapy actually initiate treatment, and of those who do initiate treatment, nearly half drop out before completing treatment. The use of the telephone to deliver treatment services has been recommended as a way to reduce many of the barriers associated with failure to initiate and sustain treatment. When administered over the telephone, cognitive behavioral therapy (CBT), a form of psychotherapy that teaches ways to modify thoughts and behaviors that contribute to depression, may be superior to face-to-face CBT in improving treatment adherence and reducing depressive symptoms. This study will compare the effectiveness of telephone CBT (T-CBT) versus face-to-face CBT (FtF-CBT) in treating people with depression.
Participation in this study will include 18 weeks of treatment and 12 months of follow-up. All participants will first undergo baseline assessments that will include a telephone interview and questionnaires about mood. Participants will then be assigned randomly to receive T-CBT or FtF-CBT. Participants in both groups will receive eighteen 45-minute sessions of their assigned treatment over 18 weeks. Sessions will occur twice a week for 2 weeks, once a week for 12 weeks, and once every 2 weeks for the last 4 weeks. During sessions, participants will learn ways to modify thoughts and behaviors that contribute to their depression and ways to maintain the lifestyle changes that they have made. Treatment sessions will be identical for both groups, except one group will receive sessions over the telephone and the other in-person at a study office. All participants will repeat the baseline assessments at Weeks 4, 9, 14, and 18 of treatment and Months 3, 6, 9, and 12 of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telephone-administered CBT | Experimental | Participants will receive telephone-administered cognitive behavioral therapy. |
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| Face-to-face CBT | Active Comparator | Participants will receive face-to-face cognitive behavioral therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone-administered cognitive behavioral therapy (T-CBT) | Behavioral | Over 18 weeks, participants will receive eighteen 45-minute sessions of T-CBT administered by a therapist. Participants will undergo telephone-administered sessions twice a week for 2 weeks, once a week for 12 weeks, and once every 2 weeks for the last 4 weeks. Participants will be taught ways to modify thoughts and behaviors that contribute to their depression and ways to maintain the lifestyle changes that they have made. |
| Measure | Description | Time Frame |
|---|---|---|
| Attrition (Number of Therapy Sessions Attended) | Number of therapy sessions attended was collected. At the end of treatment, the total number of sessions attended by each patient was collected. | Post treatment, up to 18 weeks |
| Number of Participants Who Dropped Out of Therapy | Using the number of therapy sessions attended, we categorized patients into:
| Post treatment, up to 18 weeks |
| Patient Health Questionnaire (PHQ)-9 | Measures depression on a 9 - item scale. Scores range from 0-27, with 0 being no symptoms. A difference of 5 or more points on the PHQ-9 is considered a clinically meaningful response to treatment. | Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6 post-treatment follow-up |
| Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) | Ham-D indicates Hamilton Depression Rating Scale,range is 0 to 52. A score of 0 means the best outcome with no depression symptoms reported, and a score of 52 is the worse outcome with highest level of depression reported. A difference of 3 points on the Hamilton scale has been identified as clinically significant. | Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related Quality of Life (SF-36V), Patient Satisfaction (Satisfaction Index - Mental Health), and Therapeutic Alliance (Working Alliance Inventory - Short Form) | Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David C. Mohr, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22706833 | Derived | Mohr DC, Ho J, Duffecy J, Reifler D, Sokol L, Burns MN, Jin L, Siddique J. Effect of telephone-administered vs face-to-face cognitive behavioral therapy on adherence to therapy and depression outcomes among primary care patients: a randomized trial. JAMA. 2012 Jun 6;307(21):2278-85. doi: 10.1001/jama.2012.5588. |
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Participants were recruited from November 2007 to December 2010 from general internal medicine clinics in Northwestern Medical Faculty Foundation and Northwestern Memorial Physician's Group, and from 4 primary care clinic members of Northwestern's Practice-Based Research Network.
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| ID | Title | Description |
|---|---|---|
| FG000 | Telephone-administered CBT | Participants will receive telephone-administered cognitive behavioral therapy. |
| FG001 | Face-to-face CBT | Participants will receive face-to-face cognitive behavioral therapy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Telephone-administered CBT | Participants will receive telephone-administered cognitive behavioral therapy. |
| BG001 | Face-to-face CBT | Participants will receive face-to-face cognitive behavioral therapy. |
| 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, Categorical | Count of Participants |
| 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 | Attrition (Number of Therapy Sessions Attended) | Number of therapy sessions attended was collected. At the end of treatment, the total number of sessions attended by each patient was collected. | A randomized controlled trial of 325 Chicago area primary care patients with major depressive disorder, recruited from November 1007 to December 2010. | Posted | Mean | Standard Deviation | Number of Sessions | Post treatment, up to 18 weeks | sessions | Participants |
|
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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 | Telephone-administered CBT | Participants will receive telephone-administered cognitive behavioral therapy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David C. Mohr | Northwestern University | 312-503-1403 | d-mohr@northwestern.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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|
| Face-to-face administered CBT (FtF-CBT) | Behavioral | Over 18 weeks, participants will receive eighteen 45-minute sessions of FtF-CBT administered by a therapist. Participants will undergo face-to-face administered sessions twice a week for 2 weeks, once a week for 12 weeks, and once every 2 weeks for the last 4 weeks. Participants will be taught ways to modify thoughts and behaviors that contribute to their depression and ways to maintain the lifestyle changes that they have made. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Number of Participants Who Dropped Out of Therapy | Using the number of therapy sessions attended, we categorized patients into:
| Posted | Number | participants | Post treatment, up to 18 weeks |
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| Secondary | Health-related Quality of Life (SF-36V), Patient Satisfaction (Satisfaction Index - Mental Health), and Therapeutic Alliance (Working Alliance Inventory - Short Form) | Not Posted | Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up |
| Primary | Patient Health Questionnaire (PHQ)-9 | Measures depression on a 9 - item scale. Scores range from 0-27, with 0 being no symptoms. A difference of 5 or more points on the PHQ-9 is considered a clinically meaningful response to treatment. | Posted | Mean | Full Range | units on a scale | Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6 post-treatment follow-up |
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| Primary | Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) | Ham-D indicates Hamilton Depression Rating Scale,range is 0 to 52. A score of 0 means the best outcome with no depression symptoms reported, and a score of 52 is the worse outcome with highest level of depression reported. A difference of 3 points on the Hamilton scale has been identified as clinically significant. | Posted | Mean | Full Range | units on a scale | Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up |
|
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| 0 |
| 163 |
| 0 |
| 163 |
| EG001 | Face-to-face CBT | Participants will receive face-to-face cognitive behavioral therapy. | 0 | 162 | 0 | 162 |
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| D001523 |
| Mental Disorders |
| Chi-square |
| 7.75 |
| 95 |
Attrition before week 5 was significantly lower in T-CBT than in face-to-face CBT. |
| No |
| Superiority or Other |
| Week09 |
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| Week14 |
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| Week18 |
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| 3-month follow-up |
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| 6-month follow-up |
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| Week09 |
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| Week14 |
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| Week18 |
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| 3-month follow-up |
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| 6-month follow-up |
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