A Phase 2 interventional study of Cognitive-behavioral therapy and Wait-list control in Obsessive Compulsive Disorder, sponsored by University of South Florida. Completed at 1 site in United States. Open to participants aged 7 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-11.
Sponsored by University of South Florida · Phase 2, Interventional, and Treatment
Although cognitive-behavioral therapy (CBT) is the most effective intervention for pediatric obsessive-compulsive disorder (OCD), many people do receive CBT initially. Given this, alternative ways of providing CBT need to be identified and tested. With this in mind, the proposed study examines the efficacy of a videophone based cognitive-behavioral intervention for youth with OCD. A total of 30 youth will be randomly assigned to either videophone administered CBT or an abbreviated wait-list control arm. Comprehensive assessments will be conducted by trained clinicians at relevant time-points to assess symptom severity and impairment.
Although cognitive-behavioral therapy (CBT) is the most effective intervention for pediatric obsessive-compulsive disorder (OCD), many people do receive CBT initially due, in part, to the lack of trained providers and geographic barriers (e.g., distance to such providers). Rather, the majority of youth with OCD receive psychiatric medication alone or together with unproven forms of psychotherapy. While some serotonergic medications have demonstrated utility in pediatric OCD, side effects can be common, response rates are modest at best, and symptom remission is rare. Given this, alternative ways of providing CBT need to be identified and tested to increase the number of people with access to this form of treatment. With this in mind, the proposed study examines the efficacy of a videophone based cognitive-behavioral intervention for youth with OCD. A total of 30 youth will be randomly assigned to either videophone administered CBT or an abbreviated wait-list control arm. Cognitive-behavioral therapy will be based on a demonstrated effective treatment protocol, and adapted for videophone administration. Comprehensive assessments will be conducted by trained clinicians at relevant time-points (e.g., baseline, post-treatment, follow-up) to assess symptom severity and impairment. Should supporting data be found, videophone-administered CBT would have the potential to help many more families who would otherwise remain untreated or inadequately treated. On a societal level, evaluation and dissemination of telehealth interventions such as this will lessen costs related to sustained treatment and OCD related impairment.
367 studies on the registry are indexed under Compulsive Personality Disorder; 67 are open to participants now.
This study's enrollment of 31 is below the median of 37 across 306 interventional studies indexed under Compulsive Personality Disorder.
Browse Compulsive Personality Disorder studies →University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.
Behavioral: Cognitive-behavioral therapy
Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.
Behavioral: Wait-list control
Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks.
Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.
Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). The CY-BOCS is a 10-item Semi-structured Measure of Obsession and Compulsion Severity Over the Previous Week. This Measure Will Serve as the Primary Outcome Index.
Items on this scale are summed to arrive at a total score. Scores on this scale range from 0 to 40 with higher scores corresponding to worse symptom severity.
Time frame: within one week after treatment condition was concluded
Clinical Global Impression - Severity (CGI-S; National Institute of Mental Health, 1985). The CGI-S is a 7-point Clinician Rating of Severity of Psychopathology.
Scores on this scale range from 0 to 6 with higher scores corresponding to worse symptom severity.
Time frame: within one week after treatment condition was concluded
Clinical Global Improvement (CGI; Guy, 1976). The CGI is a 7-point Rating of Treatment Response Anchored by 1 ("Very Much Improved) and 7 ("Very Much Worse").
Scores on this scale range from 1 to 7. Scores of 1 (very much improved) and 2 (much improved) are grouped together to indicate if a participate has had a beneficial response to the interview. The data represents participants who had a beneficial response to the treatment condition. Scores of 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse) are grouped together to indicate that a participant has not had a positive treatment response.
Time frame: within one week after treatment condition was concluded
| Milestone | Cognitive-behavioral Therapy | Waitlist |
|---|---|---|
| Started | 16 | 15 |
| Completed | 14 | 15 |
| Not completed | 2 | 0 |
Items on this scale are summed to arrive at a total score. Scores on this scale range from 0 to 40 with higher scores corresponding to worse symptom severity.
| units on a scale | Cognitive-behavioral Therapy | Waitlist |
|---|---|---|
| Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). The CY-BOCS is a 10-item Semi-structured Measure of Obsession and Compulsion Severity Over the Previous Week. This Measure Will Serve as the Primary Outcome Index. | 11.13 ± 10.53 | 18.53 ± 8.11 |
Scores on this scale range from 0 to 6 with higher scores corresponding to worse symptom severity.
| units on a scale | Cognitive-behavioral Therapy | Waitlist |
|---|---|---|
| Clinical Global Impression - Severity (CGI-S; National Institute of Mental Health, 1985). The CGI-S is a 7-point Clinician Rating of Severity of Psychopathology. | 1.56 ± 1.75 | 2.47 ± 1.30 |
Scores on this scale range from 1 to 7. Scores of 1 (very much improved) and 2 (much improved) are grouped together to indicate if a participate has had a beneficial response to the interview. The data represents participants who had a beneficial response to the treatment condition. Scores of 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse) are grouped together to indicate that a participant has not had a positive treatment response.
| participants | Cognitive-behavioral Therapy | Waitlist |
|---|---|---|
| Clinical Global Improvement (CGI; Guy, 1976). The CGI is a 7-point Rating of Treatment Response Anchored by 1 ("Very Much Improved) and 7 ("Very Much Worse"). | 13 | 2 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cognitive-behavioral Therapy | — | 0/16 (0%) | 0/16 (0%) |
| Waitlist | — | 0/15 (0%) | 0/15 (0%) |
| Age, Categorical(Participants) | Cognitive-behavioral Therapy | Waitlist | Total |
|---|---|---|---|
| <=18 years | 16 | 15 | 31 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Cognitive-behavioral Therapy | Waitlist | Total |
|---|---|---|---|
| Mean | 11 ± 2.5 | 11.2 ± 2.81 | 11.1 ± 2.59 |
| Sex: Female, Male(Participants) | Cognitive-behavioral Therapy | Waitlist | Total |
|---|---|---|---|
| Female | 6 | 6 | 12 |
| Male | 10 | 9 | 19 |
| Region of Enrollment(participants) | Cognitive-behavioral Therapy | Waitlist | Total |
|---|---|---|---|
| United States | 16 | 15 | 31 |
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Compulsive Personality Disorder→
University of South Florida