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Stepped Telemental Health Care Intervention for Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01906476
Recruitment Status : Completed
First Posted : July 24, 2013
Results First Posted : April 2, 2020
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
David Mohr, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Depression
Interventions Behavioral: Stepped Care
Behavioral: Telephone Cognitive Behavior Therapy
Enrollment 312
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stepped Care Telephone Cognitive Behavior Therapy
Hide Arm/Group Description

Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist

Stepped Care: Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist

Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).

Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).

Period Title: Overall Study
Started 157 155
Completed 140 139
Not Completed 17 16
Reason Not Completed
Lost to Follow-up             17             16
Arm/Group Title Stepped Care Telephone Cognitive Behavior Therapy Total
Hide Arm/Group Description

Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist

Stepped Care: Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist

Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).

Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).

Total of all reporting groups
Overall Number of Baseline Participants 157 155 312
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 157 participants 155 participants 312 participants
33
(27 to 49)
32
(26 to 45.5)
33
(27 to 47)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 155 participants 310 participants
Female
118
  76.1%
111
  71.6%
229
  73.9%
Male
37
  23.9%
44
  28.4%
81
  26.1%
[1]
Measure Analysis Population Description: Two patients did not report their gender.
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 155 participants 312 participants
Hispanic or Latino
12
   7.6%
20
  12.9%
32
  10.3%
Not Hispanic or Latino
141
  89.8%
134
  86.5%
275
  88.1%
Unknown or Not Reported
4
   2.5%
1
   0.6%
5
   1.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 155 participants 312 participants
American Indian or Alaska Native
0
   0.0%
2
   1.3%
2
   0.6%
Asian
5
   3.2%
6
   3.9%
11
   3.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
   3.2%
9
   5.8%
14
   4.5%
White
135
  86.0%
130
  83.9%
265
  84.9%
More than one race
7
   4.5%
5
   3.2%
12
   3.8%
Unknown or Not Reported
5
   3.2%
3
   1.9%
8
   2.6%
Baseline QIDS (Quick Inventory of Depressive Symptomatology)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 157 participants 155 participants 312 participants
14
(13 to 16)
14
(13 to 17)
14
(13 to 16.25)
[1]
Measure Description: QIDS is made up of 16 items and has a possible range of scores of 0 to 27. Higher scores represent worse outcomes.
PHQ-9 (Patient Health Questionnaire 9)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 157 participants 155 participants 312 participants
16
(14 to 19)
17
(14 to 19)
16
(14 to 19)
[1]
Measure Description: PHQ-9 is made up of 9 items and has a possible range of scores of 0 to 27. Higher scores represent worse outcomes.
1.Primary Outcome
Title Depression
Hide Description To measure changes in the Quick Inventory of Depressive Symptomatology (QIDS) over time. The QIDS is made up of 16 items and has a possible range of scores of 0 to 27. Higher scores represent worse outcomes.
Time Frame Baseline, midtreatment, end of treatment, 3 month post treatment, and 6 month post-treatment follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with at least one followup visit which recorded the QIDS post baseline
Arm/Group Title Stepped Care Telephone Cognitive Behavior Therapy
Hide Arm/Group Description:

Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist

Stepped Care: Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist

Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).

Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).

Overall Number of Participants Analyzed 134 136
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Midtreatment 10.51  (0.40) 11.22  (0.39)
End of Treatment 7.84  (0.38) 7.71  (0.37)
Month 3 (post treatment) 7.78  (0.42) 7.88  (0.40)
Month 6 (post treatment) 7.89  (0.44) 8.24  (0.42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stepped Care, Telephone Cognitive Behavior Therapy
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority trials of pharmaceuticals have used 30% to 50% of the difference between treatment and control conditions to define non-inferiority margins. (Jones, Jarvis, Lewis, & Ebbutt, 1996; Nutt et al., 2008). A meta-analysis of CBT found an overall effect size of d=0.82.(Cuijpers, Smit, Bohlmeijer, Hollon, & Andersson, 2010). Using the midpoint of 40% for the acceptable criterion, we set d=0.33 as the non-inferiority criterion.
Other Statistical Analysis

Cohen's d and upper limits of one-sided 95% Confidence intervals for each time are as follows:

Mid-treatment -0.19 (95% upper limit= 0.06) End of treatment 0.03 (0.24) 3 months post treatment -0.02 (0.19) 6 months post treatment -0.07 (0.14)

2.Primary Outcome
Title Cost-Effectiveness
Hide Description Measure the ratio of the difference in costs and difference in effectiveness between the two groups, Stepped care minus Telephone Cognitive Behavior Therapy. Below are reported individual cost means and standard deviations for therapist costs during study.
Time Frame Baseline to end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Stepped Care Telephone Cognitive Behavior Therapy
Hide Arm/Group Description:

Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist

Stepped Care: Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist

Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).

Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).

Overall Number of Participants Analyzed 157 155
Mean (Standard Deviation)
Unit of Measure: dollars
391.81  (229.06) 756.14  (298.64)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stepped Care, Telephone Cognitive Behavior Therapy
Comments We calculated the ICER (Incremental cost-effectiveness ratio) estimate, computed using the difference in average cost between the two arms, divided by the difference in average Depression Free Days (DFD) as defined using QIDS (Quick Inventory of Depressive Symptomatology), between the two arms, Stepped Care minus Telephone Cognitive Behavior Therapy. The confidence interval was created using bootstrapping.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter ICER estimate
Estimated Value -152.55
Confidence Interval (2-Sided) 95%
-1143.09 to 1094.72
Estimation Comments [Not Specified]
Time Frame Baseline through 6 month post-treatment followup
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stepped Care Telephone Cognitive Behavior Therapy
Hide Arm/Group Description

Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist

Stepped Care: Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist

Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).

Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).

All-Cause Mortality
Stepped Care Telephone Cognitive Behavior Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/157 (0.00%)   0/155 (0.00%) 
Hide Serious Adverse Events
Stepped Care Telephone Cognitive Behavior Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/157 (0.00%)   0/155 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stepped Care Telephone Cognitive Behavior Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/157 (0.00%)   0/155 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mary Kwasny
Organization: Northwestern University
Phone: 312-503-2294
EMail: m-kwasny@northwestern.edu
Layout table for additonal information
Responsible Party: David Mohr, Northwestern University
ClinicalTrials.gov Identifier: NCT01906476    
Other Study ID Numbers: R01MH095753-01A1-RCTTH
R01MH095753-01A1 ( U.S. NIH Grant/Contract )
First Submitted: July 17, 2013
First Posted: July 24, 2013
Results First Submitted: April 9, 2019
Results First Posted: April 2, 2020
Last Update Posted: April 2, 2020