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

NCT00498706 | Completed Phase 3 Results DMC

• 1 other identifier: R01MH059708
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression

Keywords

Depressive Disorder, Major; Cognitive Behavioral Therapy; Psychotherapy; Telemedicine; Primary Care

Outcome Measures

Primary Outcomes (4)

• 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: 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.

  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

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 at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up

Study Arms (2)

Telephone-administered CBT

EXPERIMENTAL

Participants will receive telephone-administered cognitive behavioral therapy.

Behavioral: Telephone-administered cognitive behavioral therapy (T-CBT)

Face-to-face CBT

ACTIVE COMPARATOR

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

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

Interventions

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.

Telephone-administered CBT

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.

Face-to-face CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Depression determined to be primarily of an organic etiology

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 22706833 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. David C. Mohr
• Organization: Northwestern University

d-mohr@northwestern.edu

312-503-1403

Study Officials

• David C. Mohr, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 8, 2007
• First Posted: July 10, 2007
• Study Start: December 1, 2007
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 17, 2013
• Results First Posted: July 17, 2013

Record last verified: 2013-07

Locations

US (1)