Trial Outcomes & Findings for Stepped Care for Treating Obsessive-Compulsive Disorder (NCT NCT00316355)

NCT ID: NCT00316355

Last Updated: 2018-02-22

Results Overview

The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score was used as the outcome measure. The Y-BOCS is a clinician-rated scale assessing obsession (5 items) and compulsion (5 items) symptom severity on a 0 to 4 scale. All 10 items are added for the total score, with total scores ranging from 0 to 40, and higher numbers indicating more severe symptoms.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: Pretreatment, Posttreatment, and 3-month follow-up
• Results posted on: 2018-02-22

Participant Flow

Participant milestones

Measure	Traditional CBT Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP) Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.	Stepped-Care CBT Stepped-care CBT Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP).
Overall Study STARTED	15	19
Overall Study Started Treatment	12	18
Overall Study COMPLETED	10	12
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stepped Care for Treating Obsessive-Compulsive Disorder

Baseline characteristics by cohort

Measure	Traditional CBT n=15 Participants Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP) Traditional CBT: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.	Stepped-Care CBT n=19 Participants Stepped-care CBT Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP).	Total n=34 Participants Total of all reporting groups
Age, Continuous	31.33 years STANDARD_DEVIATION 10.50 • n=93 Participants	35.95 years STANDARD_DEVIATION 16.16 • n=4 Participants	33.74 years STANDARD_DEVIATION 13.10 • n=27 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	13 Participants n=4 Participants	20 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	6 Participants n=4 Participants	14 Participants n=27 Participants
Region of Enrollment United States	15 participants n=93 Participants	19 participants n=4 Participants	34 participants n=27 Participants

PRIMARY outcome

Timeframe: Pretreatment, Posttreatment, and 3-month follow-up

Population: Randomized participants

The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score was used as the outcome measure. The Y-BOCS is a clinician-rated scale assessing obsession (5 items) and compulsion (5 items) symptom severity on a 0 to 4 scale. All 10 items are added for the total score, with total scores ranging from 0 to 40, and higher numbers indicating more severe symptoms.

Outcome measures

Measure	Traditional CBT n=15 Participants Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP) Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.	Stepped-Care CBT n=19 Participants Stepped-care CBT Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP).
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score Pretreatment	26.00 units on a scale Standard Deviation 5.54	24.47 units on a scale Standard Deviation 5.54
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score Posttreatment	14.25 units on a scale Standard Deviation 6.19	15.16 units on a scale Standard Deviation 5.54
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score 3-Month Follow-up	15.75 units on a scale Standard Deviation 6.40	13.87 units on a scale Standard Deviation 6.26

PRIMARY outcome

Timeframe: Posttreatment

Population: Treatment completers

total estimated costs calculated based upon the fixed-dose schedule

Outcome measures

Measure	Traditional CBT n=10 Participants Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP) Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.	Stepped-Care CBT n=12 Participants Stepped-care CBT Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP).
Treatment-related Total Cost Estimates	5222.80 dollars Standard Deviation 1429.15	3121.65 dollars Standard Deviation 2826.93

Adverse Events

Traditional CBT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stepped-Care CBT

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Traditional CBT n=12 participants at risk Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP) Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.	Stepped-Care CBT n=18 participants at risk Stepped-care CBT Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP).
Psychiatric disorders increased anxiety impairing functioning	0.00% 0/12	5.6% 1/18 • Number of events 1

Additional Information

David Tolin

Hartford Hospital

Phone: 860-545-7685

Email: david.tolin@hhchealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place