A Controlled Trial of Daily Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 3

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 (e.g., 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 his/her parent(s) or guardian(s) 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 (e.g., 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 (e.g., 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 child's
      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.
    

Intervention name(s): Cognitive-behavioral therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive-behavioral therapy; Children; Obsessive-compulsive disorder; Intensive Cognitive-behavioral therapy; Weekly Cognitive-behavioral therapy