DepressionPhase 3NCT00498706
Effectiveness of Telephone Versus Face-to-Face CBT in Treating People With Depression
A Phase 3 study testing Telephone-administered cognitive behavioral therapy (T-CBT) and Face-to-face administered CBT (FtF-CBT) in people with Depression, run by Northwestern University at 1 site in United States.
Trial summary
This study will compare the effectiveness of telephone versus face-to-face administration of cognitive behavioral therapy in treating people with depression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Telephone-administered cognitive behavioral therapy (T-CBT) and Face-to-face administered CBT (FtF-CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to May 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has a current diagnosis of major depressive disorder
- Has a primary care physician at Northwestern University in Illinois, or one of a number of approved community clinics in Chicago.
- Resides in Illinois
- Has a telephone
- Speaks and reads English
Who cannot join
- Hearing, voice, or visual impairment
- Meets criteria for dementia
- Diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance abuse, or other condition for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous
- Currently receiving individual psychotherapy or planning to receive psychotherapy during the treatment phase of the study
- Planning to be out of town or unavailable for treatment for 4 weeks or more during the scheduled treatment time
- Recent history of suicide attempts or is severely suicidal
- Initiated treatment with an antidepressant in the 2 months before study entry (antidepressant medication is not exclusionary)
- Depression determined to be primarily of an organic etiology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telephone Versus Face-to-Face Administration of CBT for Depression
This study will compare the effectiveness of telephone versus face-to-face administration of cognitive behavioral therapy in treating people with depression.
Read the detailed description
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.
- Conditions
- Depression
- Being tested
- Telephone-administered cognitive behavioral therapy (T-CBT), Face-to-face administered CBT (FtF-CBT)
- Keywords
- Depressive Disorder, Major, Cognitive Behavioral Therapy, Psychotherapy, Telemedicine, Primary Care
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-administered cognitive behavioral therapy (T-CBT)Behavioural
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.
Face-to-face administered CBT (FtF-CBT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Telephone-administered CBT | Experimental | Participants will receive telephone-administered cognitive behavioral therapy. Receives: Behavioral: Telephone-administered cognitive behavioral therapy (T-CBT) |
| Face-to-face CBT | Active comparator | Participants will receive face-to-face cognitive behavioral therapy. Receives: Behavioral: Face-to-face administered CBT (FtF-CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- those who discontinued treatment before session 18, and those who completed session 18.
- those who discontinued before Session 5, and those who continued.
Measured: 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: 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: Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up
Secondary outcomes (1)
Health-related Quality of Life (SF-36V), Patient Satisfaction (Satisfaction Index - Mental Health), and Therapeutic Alliance (Working Alliance Inventory - Short Form)
Measured: Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2007 (estimated)
- Study startDec 2007
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, David Mohr, National Institute of Mental Health (NIMH)
- Investigators
- David C. Mohr, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498706
- Sponsor's protocol ID
- R01MH059708
- Other IDs
- R01MH059708
- Status last verified
- Jul 2013
- First submitted
- 8 Jul 2007
- Last updated
- 17 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22706833
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Versus Face-to-Face Administration of CBT for Depression
- ClinicalTrials.gov ID
- NCT00498706
- Acronym / sponsor ID
- R01MH059708
- Conditions
- Depression
- Keywords
- Depressive Disorder, Major, Cognitive Behavioral Therapy, Psychotherapy, Telemedicine, Primary Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 10 Jul 2007 (estimated)
- Results
- Posted 17 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the effectiveness of telephone versus face-to-face administration of cognitive behavioral therapy in treating people with depression.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone-administered CBT | Experimental | Behavioral: Telephone-administered cognitive behavioral therapy (T-CBT)Participants will receive telephone-administered cognitive behavioral therapy. |
| Face-to-face CBT | Active comparator | Behavioral: Face-to-face administered CBT (FtF-CBT)Participants will receive face-to-face cognitive behavioral therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has a current diagnosis of major depressive disorder
- Has a primary care physician at Northwestern University in Illinois, or one of a number of approved community clinics in Chicago.
- Resides in Illinois
- Has a telephone
- Speaks and reads English
Key exclusion criteria (8 listed)
- Hearing, voice, or visual impairment
- Meets criteria for dementia
- Diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance abuse, or other condition for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous
- Currently receiving individual psychotherapy or planning to receive psychotherapy during the treatment phase of the study
- Planning to be out of town or unavailable for treatment for 4 weeks or more during the scheduled treatment time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone-administered cognitive behavioral therapy (T-CBT)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. | Behavioural | Telephone-administered CBT |
| Face-to-face administered CBT (FtF-CBT)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. | Behavioural | Face-to-face CBT |
Primary outcome
Attrition (Number of Therapy Sessions Attended)
Time frame: Post treatment, up to 18 weeks
Number of therapy sessions attended was collected. At the end of treatment, the total number of sessions attended by each patient was collected.
Number of Participants Who Dropped Out of Therapy
Time frame: Post treatment, up to 18 weeks
Using the number of therapy sessions attended, we categorized patients into: 1. those who discontinued treatment before session 18, and those who completed session 18. 2. those who discontinued before Session 5, and those who continued.
Patient Health Questionnaire (PHQ)-9
Time frame: Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6 post-treatment follow-up
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.
Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D)
Time frame: Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up
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.
1 secondary outcome
Health-related Quality of Life (SF-36V), Patient Satisfaction (Satisfaction Index - Mental Health), and Therapeutic Alliance (Working Alliance Inventory - Short Form)
Time frame: Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22706833Mohr 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C. Mohr, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telephone-administered cognitive behavioral therapy (T-CBT) and Face-to-face administered CBT (FtF-CBT) in people with Depression, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attrition (Number of Therapy Sessions Attended) (time frame: Post treatment, up to 18 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00498706, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2013; AzTrials last refreshed its copy on 7 Nov 2026.