Clinical trial NCT00498706: Effectiveness of Telephone Versus Face-to-Face CBT in Treating People With Depression
Official title: Telephone Versus Face-to-Face Administration of CBT for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Keywords: Depressive Disorder, Major
Cognitive Behavioral Therapy
Psychotherapy
Telemedicine
Primary Care
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-07-10
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Attrition (Number of Therapy Sessions Attended)
timeFrame: Post treatment, up to 18 weeks
measure: Number of Participants Who Dropped Out of Therapy
timeFrame: Post treatment, up to 18 weeks
measure: Patient Health Questionnaire (PHQ)-9
timeFrame: Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6 post-treatment follow-up
measure: Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D)
timeFrame: Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up
Secondary outcomes:
measure: Health-related Quality of Life (SF-36V), Patient Satisfaction (Satisfaction Index - Mental Health), and Therapeutic Alliance (Working Alliance Inventory - Short Form)
timeFrame: Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: David C. Mohr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.