Obsessive-Compulsive Disorder
Conditions
Keywords
Child, Adolescent
Brief summary
This study will determine whether cognitive behavioral therapy delivered by either psychologists or psychiatrists can improve the effectiveness of serotonin reuptake inhibitor treatment in children with obsessive compulsive disorder.
Detailed description
The vast majority of children with obsessive compulsive disorder (OCD) are given serotonin reuptake inhibitor (SRI) drugs as initial treatment. However, recommended doses of these medications leave many children with clinically significant residual symptoms. Health care experts typically recommend augmenting SRI treatment with cognitive behavioral therapy (CBT), yet this recommendation is seldom followed. This study will contrast two CBT augmentation strategies to continued medication management alone: CBT administered by a psychologist and instructional CBT (I-CBT)administered by a psychiatrist in the context of ongoing medication management. All patients in the trial will be eligible to receive a full course of CBT by study end. Participants in this study will be randomly assigned to receive CBT, I-CBT or continued medication management. All participants will continue their SRI treatment for 12 weeks. After the 12-week treatment period, participants who received I-CBT or medication management alone and who remain symptomatic will be given CBT as will participants who are asymptomatic but relapse within 6 months after treatment. Assessments will be conducted at Weeks 0, 4, 8, and 12. Follow-up assessments will be conducted at 3 and 6 months post-treatment.
Interventions
DRUGSerotonin reuptake inhibitors management
Participants are maintained on their optimized dose of SRI for OCD symptoms (see Other Names section for specific drugs and dosage ranges). If the participant has been treated with an SRI for at least 9 weeks AND has been at a stable dose for the past 3 weeks (e.g., the dose response curve is flat indicating no further improvement in OCD symptoms) OR the participant did not tolerate a dose increase to the next higher dose OR the participant has been at the maximum allowable dose for 3 weeks, then the participant is considered optimized and will be maintained on that dose. During trial, all participants will be maintained on their SRI dose during acute treatment at a constant dose unless side effects warrant downward adjustment of the SRI.
BEHAVIORALCognitive behavioral therapy by a psychologist
CBT consists of 14 visits over 12 weeks involving: (1) psychoeducation, (2), cognitive training, (3) mapping OCD, and (4) exposure and ritual prevention (EX/RP). The intervention was adapted from March and Mulle (1998) treatment protocol for pediatric OCD.
BEHAVIORALInstructional cognitive behavioral therapy by a psychiatrist
The psychiatrist who manages medication will also provide instructions in the CBT procedures that have been found to help reduce OCD symptoms, namely EX/RP. MM+I-CBT was constructed as a single-doctor best practice treatment with three primary goals: (1) inclusion of the main psychoeducational and EX/RP components of the full CBT protocol; (2) feasibility of training psychiatrists to perform the CBT component of MM+I-CBT; (3) integration with protocol medication management visits; and (4) feasibility of implementation with the constraints of a busy practice oriented primarily toward pharmacotherapy.
Sponsors
National Institute of Mental Health (NIMH)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* DSM-IV Diagnosis of obsessive compulsive disorder * CYBOCS total score greater than 16
Exclusion criteria
* Other primary or co-primary psychiatric disorder * Pervasive developmental disorder or disorders, including Asperger's Syndrome * Thought disorder * Prior failed trial of cognitive-behavioral therapy * Has pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS) or maintenance antibiotic for obsessive-compulsive disorder * Mental retardation * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) | Measured at baseline and Week 12. | OCD symptom severity was measured using the CY-BOCS, an interviewer-rated instrument that assess obsessions and compulsions separately on time consumed, distress, interference, degree of resistance, and control; it yields separate severity scores for obsessions and for compulsions (0 - 20), and a composite symptom severity score (0 to 40). Consistent with signal detection analyses examining the optimal criterion for treatment response, a CY-BOCS reduction of 30% or more from baseline to week 12 was used as the criterion for RESPONSE and was the primary dichotomous outcome measure. |
Secondary
| Measure | Time frame |
|---|---|
| Child Obsessive -Compulsive Impact Scale (COIS) | Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up |
| Child Depression Inventory | Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up |
| Pediatric Adverse Event Rating Scale (PAERS) | Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MM + CBT Participants will receive medication management plus cognitive behavioral therapy with a psychologist | 42 |
| MM + ICBT Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist | 40 |
| MM Only Participants will receive medication management only | 42 |
| Total | 124 |
Baseline characteristics
| Characteristic | MM + ICBT | MM Only | MM + CBT | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 40 Participants | 42 Participants | 42 Participants | 124 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 13.76 years STANDARD_DEVIATION 2.72 | 14.34 years STANDARD_DEVIATION 2.51 | 12.71 years STANDARD_DEVIATION 2.88 | 13.6 years STANDARD_DEVIATION 2.77 |
| Region of Enrollment United States | 40 participants | 42 participants | 42 participants | 124 participants |
| Sex: Female, Male Female | 21 Participants | 22 Participants | 23 Participants | 66 Participants |
| Sex: Female, Male Male | 19 Participants | 20 Participants | 19 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 42 | 0 / 40 | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 | 1 / 40 | 1 / 42 |
Outcome results
Primary
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
OCD symptom severity was measured using the CY-BOCS, an interviewer-rated instrument that assess obsessions and compulsions separately on time consumed, distress, interference, degree of resistance, and control; it yields separate severity scores for obsessions and for compulsions (0 - 20), and a composite symptom severity score (0 to 40). Consistent with signal detection analyses examining the optimal criterion for treatment response, a CY-BOCS reduction of 30% or more from baseline to week 12 was used as the criterion for RESPONSE and was the primary dichotomous outcome measure.
Time frame: Measured at baseline and Week 12.
Population: Intent to treat (all included)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MM + CBT | Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) | 0.69 Proportion of Participants with RESPONSE |
| MM + ICBT | Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) | 0.34 Proportion of Participants with RESPONSE |
| MM Only | Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) | 0.30 Proportion of Participants with RESPONSE |
Secondary
Child Depression Inventory
Time frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
Secondary
Child Obsessive -Compulsive Impact Scale (COIS)
Time frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
Secondary
Pediatric Adverse Event Rating Scale (PAERS)
Time frame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up