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

Depression Clinical Trial

Official title:

Telephone Versus Face-to-Face Administration of CBT for Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00498706
• Other study ID #: R01MH059708
• Secondary ID: R01MH059708
• Status: Completed
• Phase: Phase 3
• First received: July 8, 2007
• Last updated: July 15, 2013
• Start date: December 2007
• Est. completion date: May 2012

Study information

• Verified date: July 2013
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will compare the effectiveness of telephone versus face-to-face administration of cognitive behavioral therapy in treating people with depression.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Post treatment, up to 18 weeks	No
Primary	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.	Post treatment, up to 18 weeks	No
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.	Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6 post-treatment follow-up	No
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.	Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up	No
Secondary	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	No