Effectiveness of Telephone Versus Face-to-Face CBT in Treating People With Depression

NCT ID: NCT00498706

Last Updated: 2013-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 325 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2012-05-31

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Telephone-administered CBT

Participants will receive telephone-administered cognitive behavioral therapy.

Group Type: EXPERIMENTAL

Telephone-administered cognitive behavioral therapy (T-CBT)

Intervention Type: 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.

Face-to-face CBT

Participants will receive face-to-face cognitive behavioral therapy.

Group Type: ACTIVE_COMPARATOR

Face-to-face administered CBT (FtF-CBT)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

David Mohr

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David C. Mohr, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22706833 (View on PubMed)

Other Identifiers

R01MH059708

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01MH059708

Identifier Type: NIH

Identifier Source: org_study_id

View Link