Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369642
Status:
COMPLETED
Last Update Posted:
2010-08-09
First Post:
2006-08-24
Brief Title:
A Controlled Trial of Daily Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder
Sponsor:
University of South Florida
Organization:
University of South Florida
Study Overview
Official Title:
A Controlled Trial of Daily Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pediatric obsessive-compulsive disorder OCD is a chronic and often disabling illness with an estimated lifetime prevalence of 1 to 3 Pediatric OCD is associated with significant social educational and familial impairment as well as comorbid emotional and behavioral disturbances that serve to complicate the prognosis of the illness and treatment outcome While limited open treatment trials and one controlled trial have demonstrated cognitive-behavioral therapy CBT to be effective for pediatric OCD controlled trials are lacking in the literature There are a number of incremental benefits that an intensive program for OCD may offer First existing outpatient interventions typically achieve treatment gains over a 15 to 20 week period The present program typically lasts between 2 to 4 weeks and thus may present as a more timely cost-effective and efficient means of treatment for some individuals Second given that many children and adolescents may not have access to mental health professionals who are trained in empirically grounded interventions for OCD the present treatment setting allows youth to receive appropriate state of the art care Finally evidence suggests that daily CBT may be particularly effective in treating children who have been refractory to prior treatments eg medication or once per week CBT Prior to treatment all consenting families will be randomly assigned to either the treatment condition or a three-week wait-list control condition Those families randomized to the wait-list condition will receive treatment immediately after the three weeks are completed The treatment group will be administered all measures immediately before treatment immediately after treatment and three months after treatment The wait-list control condition will be administered all measures upon starting the wait-list period immediately following the conclusion of the three-week wait-list period and after the treatment program has finished The purpose of the current study is to evaluate the efficacy of daily cognitive-behavioral treatment for pediatric OCD
Detailed Description:
Distressing intrusive thoughts images or impulses and repetitive mental or behavioral rituals aimed to reduce distress are the hallmark of adult and pediatric obsessive-compulsive disorder OCD Epidemiological studies suggest a prevalence rate of between 1 to 4 in children and adolescents Douglass Moffitt Dar McGee Silva 1995 Flament Whitaker Rapoport Davies 1988 Zohar 1999 If untreated OCD is related to significant social academic and familial impairment Koran Thienemann Davenport 1996 Piacentini et al 2003
Cognitive-behavioral therapy CBT is a form of psychotherapy with proven efficacy for OCD treatment in adult populations see Franklin Foa 2002 for a review More recently several open Benazon Ager Rosenberg 2002 March Mulle Herbel 1994 Piacentini Bergman Jacobs McCracken Kretchman 2002 and one controlled trial de Haan Hoogduin Buitelaar Keijsers 1998 have supported the effectiveness of this approach with children and adolescents diagnosed with OCD Cognitive-behavioral therapy for adult and pediatric OCD can be broken down into two general components First in exposure and response prevention ERP patients are gradually exposed to anxiety-provoking stimuli while refraining from engaging in compulsive behaviors or rituals Meyer 1966 The extended exposure to anxiety-provoking stimuli causes anxiety to habituate and provides objective data that contradicts inaccurate expectations of harm and responsibility Foa Kozac 1996 Second cognitive therapy teaches the patient to identify and correct anxiety-provoking cognitions that often motivate compulsive behaviors Objective realistic cognitions that are not linked to obsessive-compulsive anxiety will result in reduced needs to perform compulsive acts
Although the results of the above mentioned psychotherapy trials as well as a number of pharmacological treatment trials are promising Cook et al 2001 DeVeaugh-Geiss Moroz Biederman Cantwell 1992 Geller et al 2001 Liebowitz et al 2002 March et al 1998 Riddle et al 2001 it is important to note that a relatively large number of patients do not respond to treatment in a clinically significant manner For example the treatment response rates in recent major drug trials ranged from 42 to 67 Cook et al 2001 DeVeaugh-Geiss et al 1992 Geller et al 2001 Liebowitz et al 2002 Riddle et al 2001 whereas the treatment response rate in the referenced psychotherapy trials ranged from 63 to 79 As such it is important to identify and test potential treatment approaches that may be suitable for treatment refractory pediatric OCD patients
One manner of treating children with OCD who do no adequately respond to conventional medication or psychotherapy interventions is through intensive CBT The UF OCD Program in the Department of Psychiatry at the University of Florida utilizes the principles of CBT Our intensive program provides CBT services to children on an outpatient basis Intensive outpatient treatment involves the child and hisher parents or guardians moving to Gainesville for three weeks which usually requires staying in a hotel unless the person has friends or relatives living in the area Patients are seen five days per week for approximately three weeks Sessions typically involve exposure and response prevention in conjunction with cognitive therapy for older children Family members are involved extensively in treatment to assist with the completion of daily homework exercises and generalization of skills to the home environment In addition to being an alternative approach for treatment refractory youth there are a number of other benefits that an intensive program for pediatric OCD may offer First an intensive approach may be well suited for children with severe symptomatology or functional impairment eg not going to school Franklin Tolin March Foa 2001 Storch Gelfand Geffken Goodman 2003 Second existing outpatient interventions typically achieve treatment gains over a 15 to 20 week period Intensive treatment typically lasts three to four weeks and thus may present as a more timely cost-effective and efficient means of treatment particularly when the child is missing out on important normative events eg school attendance Third many people do not have access to mental health professionals who are trained in empirically grounded OCD treatment and thus are unable to receive the most effective care For example Flament et al 1988 found that only 22 of a sample of children with OCD were receiving mental health services Moreover none of those being treated were receiving appropriate empirically validated intervention Finally time-limited intensive programs may enhance the childs motivation by becoming the primary focus for several weeks which may not be the case with standard weekly treatment Foa Steketee 1987
Although several open and controlled trials of intensive psychotherapy for adult OCD have been published Abramowitz Foa Franklin 2003 Cottraux et al 2001 Foa Kozak Steketee McCarthy 1992 Storch et al 2003 to date only two examples of intensive outpatient treatment for OCD in childhood has been reported Franklin et al 2001 Storch et al 2004 Franklin et al 2001 describes a 12-year-old boy with severe OCD who was seen five days per week for a total of 11 sessions Results indicated marked improvements in clinician-rated OCD symptoms and self-reported depressive symptoms Storch et al 2004 provides data on five children with OCD consecutively seen in intensive cognitive-behavioral psychotherapy Assessments were conducted at baseline and after treatment All participants were classified as treatment responders much improved or very much improved Two of the participants did not meet diagnostic criteria for OCD following treatment The severity of clinician-rated OCD symptoms and impairment significantly decreased after the intervention
Under the proposed controlled trial we plan to examine the efficacy of daily cognitive-behavioral psychotherapy to 50 consecutive children and adolescents who enroll in the UF OCD program Children will be randomized to one of two treatment conditions one consists of receiving cognitive-behavioral therapy every weekday for three-weeks the other consists of receiving treatment as usual which consists of once per week outpatient cognitive-behavioral therapy sessions As compared to the once per week therapy condition we predict decreases in OCD general anxiety and depressive symptomatology and functional impairment at post-intervention for youth in the daily therapy condition
Cognitive-behavioral therapy CBT is a form of psychotherapy with proven efficacy for OCD treatment in adult populations see Franklin Foa 2002 for a review More recently several open Benazon Ager Rosenberg 2002 March Mulle Herbel 1994 Piacentini Bergman Jacobs McCracken Kretchman 2002 and one controlled trial de Haan Hoogduin Buitelaar Keijsers 1998 have supported the effectiveness of this approach with children and adolescents diagnosed with OCD Cognitive-behavioral therapy for adult and pediatric OCD can be broken down into two general components First in exposure and response prevention ERP patients are gradually exposed to anxiety-provoking stimuli while refraining from engaging in compulsive behaviors or rituals Meyer 1966 The extended exposure to anxiety-provoking stimuli causes anxiety to habituate and provides objective data that contradicts inaccurate expectations of harm and responsibility Foa Kozac 1996 Second cognitive therapy teaches the patient to identify and correct anxiety-provoking cognitions that often motivate compulsive behaviors Objective realistic cognitions that are not linked to obsessive-compulsive anxiety will result in reduced needs to perform compulsive acts
Although the results of the above mentioned psychotherapy trials as well as a number of pharmacological treatment trials are promising Cook et al 2001 DeVeaugh-Geiss Moroz Biederman Cantwell 1992 Geller et al 2001 Liebowitz et al 2002 March et al 1998 Riddle et al 2001 it is important to note that a relatively large number of patients do not respond to treatment in a clinically significant manner For example the treatment response rates in recent major drug trials ranged from 42 to 67 Cook et al 2001 DeVeaugh-Geiss et al 1992 Geller et al 2001 Liebowitz et al 2002 Riddle et al 2001 whereas the treatment response rate in the referenced psychotherapy trials ranged from 63 to 79 As such it is important to identify and test potential treatment approaches that may be suitable for treatment refractory pediatric OCD patients
One manner of treating children with OCD who do no adequately respond to conventional medication or psychotherapy interventions is through intensive CBT The UF OCD Program in the Department of Psychiatry at the University of Florida utilizes the principles of CBT Our intensive program provides CBT services to children on an outpatient basis Intensive outpatient treatment involves the child and hisher parents or guardians moving to Gainesville for three weeks which usually requires staying in a hotel unless the person has friends or relatives living in the area Patients are seen five days per week for approximately three weeks Sessions typically involve exposure and response prevention in conjunction with cognitive therapy for older children Family members are involved extensively in treatment to assist with the completion of daily homework exercises and generalization of skills to the home environment In addition to being an alternative approach for treatment refractory youth there are a number of other benefits that an intensive program for pediatric OCD may offer First an intensive approach may be well suited for children with severe symptomatology or functional impairment eg not going to school Franklin Tolin March Foa 2001 Storch Gelfand Geffken Goodman 2003 Second existing outpatient interventions typically achieve treatment gains over a 15 to 20 week period Intensive treatment typically lasts three to four weeks and thus may present as a more timely cost-effective and efficient means of treatment particularly when the child is missing out on important normative events eg school attendance Third many people do not have access to mental health professionals who are trained in empirically grounded OCD treatment and thus are unable to receive the most effective care For example Flament et al 1988 found that only 22 of a sample of children with OCD were receiving mental health services Moreover none of those being treated were receiving appropriate empirically validated intervention Finally time-limited intensive programs may enhance the childs motivation by becoming the primary focus for several weeks which may not be the case with standard weekly treatment Foa Steketee 1987
Although several open and controlled trials of intensive psychotherapy for adult OCD have been published Abramowitz Foa Franklin 2003 Cottraux et al 2001 Foa Kozak Steketee McCarthy 1992 Storch et al 2003 to date only two examples of intensive outpatient treatment for OCD in childhood has been reported Franklin et al 2001 Storch et al 2004 Franklin et al 2001 describes a 12-year-old boy with severe OCD who was seen five days per week for a total of 11 sessions Results indicated marked improvements in clinician-rated OCD symptoms and self-reported depressive symptoms Storch et al 2004 provides data on five children with OCD consecutively seen in intensive cognitive-behavioral psychotherapy Assessments were conducted at baseline and after treatment All participants were classified as treatment responders much improved or very much improved Two of the participants did not meet diagnostic criteria for OCD following treatment The severity of clinician-rated OCD symptoms and impairment significantly decreased after the intervention
Under the proposed controlled trial we plan to examine the efficacy of daily cognitive-behavioral psychotherapy to 50 consecutive children and adolescents who enroll in the UF OCD program Children will be randomized to one of two treatment conditions one consists of receiving cognitive-behavioral therapy every weekday for three-weeks the other consists of receiving treatment as usual which consists of once per week outpatient cognitive-behavioral therapy sessions As compared to the once per week therapy condition we predict decreases in OCD general anxiety and depressive symptomatology and functional impairment at post-intervention for youth in the daily therapy condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None