Trial Outcomes & Findings for Stepped Telemental Health Care Intervention for Depression (NCT NCT01906476)
NCT ID: NCT01906476
Last Updated: 2023-02-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
312 participants
Primary outcome timeframe
Baseline, midtreatment, end of treatment, 3 month post treatment, and 6 month post-treatment follow-up
Results posted on
2023-02-08
Participant Flow
Participant milestones
| Measure |
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
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
|
Telephone Cognitive Behavior Therapy
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 Study
STARTED
|
157
|
155
|
|
Overall Study
COMPLETED
|
140
|
139
|
|
Overall Study
NOT COMPLETED
|
17
|
16
|
Reasons for withdrawal
| Measure |
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
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
|
Telephone Cognitive Behavior Therapy
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 Study
Lost to Follow-up
|
17
|
16
|
Baseline Characteristics
Two patients did not report their gender.
Baseline characteristics by cohort
| Measure |
Stepped Care
n=157 Participants
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
|
Telephone Cognitive Behavior Therapy
n=155 Participants
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
n=312 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33 years
n=157 Participants
|
32 years
n=155 Participants
|
33 years
n=312 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=155 Participants • Two patients did not report their gender.
|
111 Participants
n=155 Participants • Two patients did not report their gender.
|
229 Participants
n=310 Participants • Two patients did not report their gender.
|
|
Sex: Female, Male
Male
|
37 Participants
n=155 Participants • Two patients did not report their gender.
|
44 Participants
n=155 Participants • Two patients did not report their gender.
|
81 Participants
n=310 Participants • Two patients did not report their gender.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=157 Participants
|
20 Participants
n=155 Participants
|
32 Participants
n=312 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
141 Participants
n=157 Participants
|
134 Participants
n=155 Participants
|
275 Participants
n=312 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=157 Participants
|
1 Participants
n=155 Participants
|
5 Participants
n=312 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=157 Participants
|
2 Participants
n=155 Participants
|
2 Participants
n=312 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=157 Participants
|
6 Participants
n=155 Participants
|
11 Participants
n=312 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=157 Participants
|
0 Participants
n=155 Participants
|
0 Participants
n=312 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=157 Participants
|
9 Participants
n=155 Participants
|
14 Participants
n=312 Participants
|
|
Race (NIH/OMB)
White
|
135 Participants
n=157 Participants
|
130 Participants
n=155 Participants
|
265 Participants
n=312 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=157 Participants
|
5 Participants
n=155 Participants
|
12 Participants
n=312 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=157 Participants
|
3 Participants
n=155 Participants
|
8 Participants
n=312 Participants
|
|
Baseline QIDS (Quick Inventory of Depressive Symptomatology)
|
14 units on a scale
n=157 Participants
|
14 units on a scale
n=155 Participants
|
14 units on a scale
n=312 Participants
|
|
PHQ-9 (Patient Health Questionnaire 9)
|
16 units on a scale
n=157 Participants
|
17 units on a scale
n=155 Participants
|
16 units on a scale
n=312 Participants
|
PRIMARY outcome
Timeframe: Baseline, midtreatment, end of treatment, 3 month post treatment, and 6 month post-treatment follow-upPopulation: Participants with at least one followup visit which recorded the QIDS post baseline
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.
Outcome measures
| Measure |
Stepped Care
n=134 Participants
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
|
Telephone Cognitive Behavior Therapy
n=136 Participants
Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).
Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).
|
|---|---|---|
|
Depression
Midtreatment
|
10.51 units on a scale
Standard Error 0.40
|
11.22 units on a scale
Standard Error 0.39
|
|
Depression
End of Treatment
|
7.84 units on a scale
Standard Error 0.38
|
7.71 units on a scale
Standard Error 0.37
|
|
Depression
Month 3 (post treatment)
|
7.78 units on a scale
Standard Error 0.42
|
7.88 units on a scale
Standard Error 0.40
|
|
Depression
Month 6 (post treatment)
|
7.89 units on a scale
Standard Error 0.44
|
8.24 units on a scale
Standard Error 0.42
|
PRIMARY outcome
Timeframe: Baseline to end of treatmentPopulation: All randomized participants
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.
Outcome measures
| Measure |
Stepped Care
n=157 Participants
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
|
Telephone Cognitive Behavior Therapy
n=155 Participants
Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).
Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).
|
|---|---|---|
|
Cost-Effectiveness
|
391.81 dollars
Standard Deviation 229.06
|
756.14 dollars
Standard Deviation 298.64
|
Adverse Events
Stepped Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Telephone Cognitive Behavior Therapy
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place