Trial Outcomes & Findings for Sequencing CBT for Child Anxiety: CBT Plus Sertraline Versus Switch to Sertraline (NCT NCT01977729)
NCT ID: NCT01977729
Last Updated: 2016-05-16
Results Overview
Youth outcome will be assessed on a global level using the Clinical Global Impression (CGI) Severity Scale, ranging from 1 (not at all) to 7 (among the most extremely ill patients). Higher ratings indicate greater anxiety symptom severity. The CGI Improvement Scale ranges from 1 (very much improved) to 7 (very much worse). Lower ratings indicate greater improvement on anxiety symptom severity. A CGI Improvement Scale rating of 1 or 2 indicates clinically meaningful improvements in anxiety symptom severity.
TERMINATED
PHASE2
1 participants
20 weeks from enrollment
2016-05-16
Participant Flow
Participant milestones
| Measure |
All Participants
Only one participant was recruited, but never randomized.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Participants
Only one participant was recruited, but never randomized.
|
|---|---|
|
Overall Study
Study terminated
|
1
|
Baseline Characteristics
Sequencing CBT for Child Anxiety: CBT Plus Sertraline Versus Switch to Sertraline
Baseline characteristics by cohort
| Measure |
All Study Participants
n=1 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 weeks from enrollmentPopulation: Medication was never given, and tests were never done.
Youth outcome will be assessed on a global level using the Clinical Global Impression (CGI) Severity Scale, ranging from 1 (not at all) to 7 (among the most extremely ill patients). Higher ratings indicate greater anxiety symptom severity. The CGI Improvement Scale ranges from 1 (very much improved) to 7 (very much worse). Lower ratings indicate greater improvement on anxiety symptom severity. A CGI Improvement Scale rating of 1 or 2 indicates clinically meaningful improvements in anxiety symptom severity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 20 weeks from enrollmentPopulation: Study was terminated before randomization.
Multidimensional Anxiety Scale for Children (MASC-2; Self-report and Parent completed). Treatment outcome will be assessed on a specific symptom level from the youth's and parent's perspective using the MASC-2. The MASC-2 consists of 50 items across 5 factors: Separation Anxiety/Phobias, Generalized Anxiety Disorder, Social Anxiety, Obsessions \& Compulsions, and Harm Avoidance. MASC T-scores less than 65 indicate the child is no longer in the clinical range of anxiety symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 20 weeks from enrollmentPopulation: No data collected.
Positive and Negative Affect Scale for Children (PANAS-C). Negative affect (NA) will be assessed using the NA subscale on the PANAS-C. The 15 NA items (e.g., sad, miserable) on the 27-item PANAS-C are scored 1 (very slightly or not at all) to 5 (extremely). Higher scores in the NA subscale indicate higher levels of negative affect.
Outcome measures
Outcome data not reported
Adverse Events
CBT With SRT
Switch to SRT Alone
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