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Trial Outcomes & Findings for Text Messaging and Cognitive Behavioral Therapy for Depression (NCT NCT01083628)

NCT ID: NCT01083628

Last Updated: 2019-08-12

Results Overview

The PHQ-9 (Patient Health Questionnaire - 9) is commonly used to screen for depression and to monitor progression of depressive symptoms over time. The scores represent the following depression severity: 0-4: minimal depression, 5-9: mild depression, 10-14: moderate depression, 15-19: moderately severe, 20-27: severe. A score of 10 is often recommended as the cut-off score for diagnosing an episode of depression that may require treatment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

85 participants

Primary outcome timeframe

16 weeks

Results posted on

2019-08-12

Participant Flow

Participant milestones

Participant milestones
Measure
Group CBT With Text Messaging Adjunct
Group CBT for Depression with MoodText: Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis.
Group CBT for Depression
Group CBT for Depression: Standard group CBT for depression using BRIGHT manual
Overall Study
STARTED
45
40
Overall Study
COMPLETED
45
40
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Text Messaging and Cognitive Behavioral Therapy for Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group CBT With Text Messaging Adjunct
n=45 Participants
Group CBT for Depression with MoodText: Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis.
Group CBT for Depression
n=40 Participants
Group CBT for Depression: Standard group CBT for depression using BRIGHT manual
Total
n=85 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
45 Participants
n=93 Participants
40 Participants
n=4 Participants
85 Participants
n=27 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Continuous
51.71 years
STANDARD_DEVIATION 11.55 • n=93 Participants
51.83 years
STANDARD_DEVIATION 11.73 • n=4 Participants
51.75 years
STANDARD_DEVIATION 11.62 • n=27 Participants
Sex: Female, Male
Female
38 Participants
n=93 Participants
29 Participants
n=4 Participants
67 Participants
n=27 Participants
Sex: Female, Male
Male
7 Participants
n=93 Participants
11 Participants
n=4 Participants
18 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
45 Participants
n=93 Participants
40 Participants
n=4 Participants
85 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Region of Enrollment
United States
45 participants
n=93 Participants
40 participants
n=4 Participants
85 participants
n=27 Participants
PHQ-9
13.36 units on a scale
STANDARD_DEVIATION 5.96 • n=93 Participants
13.13 units on a scale
STANDARD_DEVIATION 4.99 • n=4 Participants
13.25 units on a scale
STANDARD_DEVIATION 5.68 • n=27 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: The number of participants analyzed in this intention-to-treat analyses represents the number of participants that provided PHQ-9 scores at the end of the study period, at 16 weeks. Because the PHQ-9 was filled in during psychotherapy sessions, this number is smaller than the original sample (n=44, n=38) due to patient drop-out of psychotherapy.

The PHQ-9 (Patient Health Questionnaire - 9) is commonly used to screen for depression and to monitor progression of depressive symptoms over time. The scores represent the following depression severity: 0-4: minimal depression, 5-9: mild depression, 10-14: moderate depression, 15-19: moderately severe, 20-27: severe. A score of 10 is often recommended as the cut-off score for diagnosing an episode of depression that may require treatment.

Outcome measures

Outcome measures
Measure
Group CBT With Text Messaging Adjunct
n=18 Participants
Group CBT for Depression with MoodText: Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis.
Group CBT for Depression
n=9 Participants
Group CBT for Depression: Standard group CBT for depression using BRIGHT manual
PHQ-9 Depression Symptoms
6 units on a scale
Standard Deviation 4.2
12.67 units on a scale
Standard Deviation 6.4

SECONDARY outcome

Timeframe: 16 weeks

Population: For the attendance analyses, 3 patients (1 in the intervention and 2 in the control) were excluded, because the study ended before these patients had been offered 16 sessions of psychotherapy.

Number of sessions attended

Outcome measures

Outcome measures
Measure
Group CBT With Text Messaging Adjunct
n=44 Participants
Group CBT for Depression with MoodText: Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis.
Group CBT for Depression
n=38 Participants
Group CBT for Depression: Standard group CBT for depression using BRIGHT manual
Attendance
6 sessions
Standard Deviation 2.3
2.5 sessions
Standard Deviation 1.4

SECONDARY outcome

Timeframe: 16 weeks

Population: For the duration of therapy analyses, 3 patients (1 in the intervention and 2 in the control) were excluded, because the study ended before these patients had been offered 16 sessions of psychotherapy.

Number of weeks until patients dropped out of therapy

Outcome measures

Outcome measures
Measure
Group CBT With Text Messaging Adjunct
n=44 Participants
Group CBT for Depression with MoodText: Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis.
Group CBT for Depression
n=38 Participants
Group CBT for Depression: Standard group CBT for depression using BRIGHT manual
Duration of Therapy Attended
13.5 weeks
Interval 1.0 to 16.0
3 weeks
Interval 1.0 to 16.0

Adverse Events

Group CBT With Text Messaging Adjunct

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group CBT for Depression

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. Adrian Aguilera

University of California, Berkeley

Phone: 510-642-8564

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place