Trial Outcomes & Findings for Effectiveness of Telephone Versus Face-to-Face CBT in Treating People With Depression (NCT NCT00498706)

Results Overview

Number of therapy sessions attended was collected. At the end of treatment, the total number of sessions attended by each patient was collected.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

325 participants

Primary outcome timeframe

Post treatment, up to 18 weeks

Results posted on

2013-07-17

Participant Flow

Participants were recruited from November 2007 to December 2010 from general internal medicine clinics in Northwestern Medical Faculty Foundation and Northwestern Memorial Physician's Group, and from 4 primary care clinic members of Northwestern's Practice-Based Research Network.

Participant milestones

Participant milestones
Measure	Telephone-administered CBT Participants will receive telephone-administered cognitive behavioral therapy.	Face-to-face CBT Participants will receive face-to-face cognitive behavioral therapy.
Overall Study STARTED	163	162
Overall Study Post Treatment Week 18	163	162
Overall Study COMPLETED	163	162
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telephone-administered CBT n=163 Participants Participants will receive telephone-administered cognitive behavioral therapy.	Face-to-face CBT n=162 Participants Participants will receive face-to-face cognitive behavioral therapy.	Total n=325 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	150 Participants n=5 Participants	148 Participants n=7 Participants	298 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Age Continuous	47.8 years STANDARD_DEVIATION 12.6 • n=5 Participants	47.5 years STANDARD_DEVIATION 13.5 • n=7 Participants	47.6 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	125 Participants n=5 Participants	127 Participants n=7 Participants	252 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	35 Participants n=7 Participants	73 Participants n=5 Participants
Region of Enrollment United States	163 participants n=5 Participants	162 participants n=7 Participants	325 participants n=5 Participants

PRIMARY outcome

Timeframe: Post treatment, up to 18 weeks

Population: A randomized controlled trial of 325 Chicago area primary care patients with major depressive disorder, recruited from November 1007 to December 2010.

Number of therapy sessions attended was collected. At the end of treatment, the total number of sessions attended by each patient was collected.

Outcome measures

Outcome measures
Measure	Telephone-administered CBT n=2518 sessions Participants will receive telephone-administered cognitive behavioral therapy.	Face-to-face CBT n=2221 sessions Participants will receive face-to-face cognitive behavioral therapy.
Attrition (Number of Therapy Sessions Attended)	15.4 Number of Sessions Standard Deviation 4.4	13.7 Number of Sessions Standard Deviation 6.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Telephone-administered CBT n=163 Participants Participants will receive telephone-administered cognitive behavioral therapy.	Face-to-face CBT n=162 Participants Participants will receive face-to-face cognitive behavioral therapy.
Number of Participants Who Dropped Out of Therapy those who discontinued treatment before session 18	34 participants	53 participants
Number of Participants Who Dropped Out of Therapy those who discontinued before Session 5,	7 participants	21 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Telephone-administered CBT n=162 Participants Participants will receive telephone-administered cognitive behavioral therapy.	Face-to-face CBT n=163 Participants Participants will receive face-to-face cognitive behavioral therapy.
Patient Health Questionnaire (PHQ)-9 3-month follow-up	7.59 units on a scale Interval 6.6 to 8.58	6.60 units on a scale Interval 5.56 to 7.64
Patient Health Questionnaire (PHQ)-9 Baseline	16.76 units on a scale Full Range 4.7 • Interval 16.24 to 17.29	16.76 units on a scale Full Range 4.8 • Interval 16.24 to 17.29
Patient Health Questionnaire (PHQ)-9 Week04	10.78 units on a scale Interval 9.92 to 11.64	10.09 units on a scale Interval 9.21 to 10.97
Patient Health Questionnaire (PHQ)-9 Week09	9.05 units on a scale Interval 8.13 to 9.96	8.62 units on a scale Interval 7.64 to 9.59
Patient Health Questionnaire (PHQ)-9 Week14	8.55 units on a scale Interval 7.53 to 9.56	7.77 units on a scale Interval 6.73 to 8.82
Patient Health Questionnaire (PHQ)-9 Week18	6.65 units on a scale Interval 5.72 to 7.58	6.74 units on a scale Interval 5.74 to 7.73
Patient Health Questionnaire (PHQ)-9 6-month follow-up	8.42 units on a scale Interval 7.38 to 9.46	6.30 units on a scale Interval 5.24 to 7.37

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Telephone-administered CBT n=163 Participants Participants will receive telephone-administered cognitive behavioral therapy.	Face-to-face CBT n=162 Participants Participants will receive face-to-face cognitive behavioral therapy.
Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) Baseline	22.83 units on a scale Full Range 4.6 • Interval 22.34 to 23.33	22.83 units on a scale Full Range 4.6 • Interval 22.34 to 23.33
Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) Week04	18.07 units on a scale Interval 17.16 to 18.98	17.86 units on a scale Interval 16.96 to 18.77
Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) Week09	15.62 units on a scale Interval 14.6 to 16.65	16.45 units on a scale Interval 15.4 to 17.51
Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) Week14	14.94 units on a scale Interval 13.77 to 16.12	14.18 units on a scale Interval 12.97 to 15.39
Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) Week18	13.58 units on a scale Interval 12.42 to 14.74	12.51 units on a scale Interval 11.22 to 13.81
Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) 3-month follow-up	14.58 units on a scale Interval 13.45 to 15.71	12.33 units on a scale Interval 11.1 to 13.64
Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) 6-month follow-up	15.06 units on a scale Interval 13.84 to 16.27	12.14 units on a scale Interval 10.84 to 13.45

SECONDARY outcome

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

Outcome measures

Outcome data not reported

Adverse Events

Telephone-administered CBT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Face-to-face CBT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David C. Mohr

Northwestern University

Phone: 312-503-1403

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place