Anxiety Disorders, Generalized Anxiety Disorder, Social Phobia
Conditions
Keywords
Phobic Disorders, Anxiety, Separation
Brief summary
This randomized, controlled trial compared the efficacy of the medication sertraline (Zoloft®), cognitive-behavioral therapy, the combination of these treatments, and placebo for youth with anxiety disorders.
Detailed description
Anxiety disorders are among the most common conditions affecting children and adolescents. These disorders impair school, social, and family functioning. When left untreated, they also put children at risk for major depression and substance abuse in late adolescence and adulthood. Previous studies demonstrated the efficacy of cognitive behavioral therapy and selective serotonin-reuptake inhibitors for the treatment of child anxiety disorders. This study is testing the relative and combined efficacy of cognitive behavioral therapy and selective serotonin reuptake inhibitors as compared to each other and pill placebo. During Phase I of this two-phase study, 488 participants were randomly assigned to receive sertraline (Zoloft), cognitive behavioral therapy, a combination of these treatments, or a placebo for 12 weeks. Phase II involved a 6-month maintenance period for participants.
Interventions
DRUGSertraline (SRT)
Participants were treated with sertraline.
BEHAVIORALCognitive Behavioral Therapy (CBT)
Participants received CBT.
DRUGPlacebo
Participants were treated with a placebo pill.
Sponsors
National Institute of Mental Health (NIMH)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for separation anxiety disorder, social phobia, or generalized anxiety disorder
Exclusion criteria
* Major neurological disorder or medical illness that would interfere with participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression - Improvement Scale | Measured at Week 12 | The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1-Very much improved; 2-Much improved; 3-Minimally improved; 4-No change; 5-Minimally worse; 6-Much worse; 7-Very much worse. Response rates are reported as a percentage of participants who score 1-Very much improved; 2-Much improved on the The Clinical Global Impression - Improvement scale. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1 Setraline Participants will receive sertraline for 12 weeks
Sertraline: Participants will take sertraline for 12 weeks. | 133 |
| 2 CBT Participants will receive cognitive behavioral therapy for 12 weeks
Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks. | 139 |
| 3 Combination Setraline and CBT Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks
Sertraline: Participants will take sertraline for 12 weeks.
Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks. | 140 |
| 4 Placebo Participants will receive placebo for 12 weeks
Placebo: Participants will take placebo capsules for 12 weeks. | 76 |
| Total | 488 |
Baseline characteristics
| Characteristic | 1 Setraline | 2 CBT | 3 Combination Setraline and CBT | 4 Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 133 Participants | 139 Participants | 140 Participants | 76 Participants | 488 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 6 Participants | 1 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 14 Participants | 11 Participants | 7 Participants | 44 Participants |
| Race (NIH/OMB) More than one race | 12 Participants | 15 Participants | 5 Participants | 7 Participants | 39 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 103 Participants | 106 Participants | 116 Participants | 60 Participants | 385 Participants |
| Region of Enrollment United States | 133 participants | 139 participants | 140 participants | 76 participants | 488 participants |
| Sex: Female, Male Female | 61 Participants | 72 Participants | 72 Participants | 37 Participants | 242 Participants |
| Sex: Female, Male Male | 72 Participants | 67 Participants | 68 Participants | 39 Participants | 246 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 133 | 0 / 139 | 0 / 140 | 0 / 76 |
| serious Total, serious adverse events | 2 / 133 | 0 / 139 | 1 / 140 | 0 / 76 |
Outcome results
Primary
Clinical Global Impression - Improvement Scale
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1-Very much improved; 2-Much improved; 3-Minimally improved; 4-No change; 5-Minimally worse; 6-Much worse; 7-Very much worse. Response rates are reported as a percentage of participants who score 1-Very much improved; 2-Much improved on the The Clinical Global Impression - Improvement scale.
Time frame: Measured at Week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 Setraline | Clinical Global Impression - Improvement Scale | 54.9 percentage of participants |
| 2 CBT | Clinical Global Impression - Improvement Scale | 59.7 percentage of participants |
| 3 Combination Setraline and CBT | Clinical Global Impression - Improvement Scale | 80.7 percentage of participants |
| 4 Placebo | Clinical Global Impression - Improvement Scale | 23.7 percentage of participants |