Obsessive-compulsive Disorder
Conditions
Keywords
Anxiety, Behavior therapy, Cognitive-behavioral therapy, Stepped care, Cost-effectiveness
Brief summary
This study will determine the effectiveness and cost-effectiveness of a stepped-care treatment program for people with obsessive-compulsive disorder.
Detailed description
Obsessive-Compulsive Disorder (OCD) is a chronic and debilitating anxiety disorder. People with OCD often experience recurrent unwanted thoughts, called obsessions, and repetitive behaviors, called compulsions. These thoughts and behaviors interfere with everyday life to a great extent. Currently, the most frequently used psychosocial treatment for OCD is cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP). However, although effective, this treatment approach is largely inaccessible, time-consuming, labor-intensive, and expensive. A stepped-care approach to treating OCD may be more cost-effective and therefore more accessible for many individuals. Stepped-care CBT begins with the least expensive, least intrusive, most accessible option, and works up to the most expensive option if the less intrusive treatments do not work. This study will determine the benefits and cost-effectiveness of a stepped care treatment program for OCD. Participants in this open label study will be randomly assigned to receive CBT for 6 to 14 weeks either through the stepped-care approach or immediately upon study entry. Participants will report to the study site for treatments and assessments on a regular basis, ranging from every 2 weeks to twice a week, depending on the stage of the study and the assigned treatment group. Stepped-care CBT will begin with self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement. If ineffective, this treatment will be followed by therapist-administered EX/RP. OCD symptoms will be assessed at Week 6. Participants who have responded to treatment after 6 weeks will not receive further treatment. All others will continue for an additional 8 weeks. These participants' OCD symptoms will be assessed again at Week 14. Participants assigned to the stepped-care approach whose OCD symptoms improved initially, but relapsed without further treatment by the Week 14 evaluation will receive full-scale CBT. Outcomes will be assessed again at 1- and 3-month follow-up visits.
Interventions
BEHAVIORALStepped-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).
BEHAVIORALTraditional CBT
CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.
Sponsors
National Institute of Mental Health (NIMH)
Hartford Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Primary diagnosis of OCD of moderate or greater severity * Presence of OCD symptoms for at least 1 year
Exclusion criteria
* History of psychotic or developmental disorder * Uncontrolled bipolar disorder * Serious suicide risk * Prior history of adequate CBT, including exposure and response prevention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score | Pretreatment, Posttreatment, and 3-month follow-up | 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. |
| Treatment-related Total Cost Estimates | Posttreatment | total estimated costs calculated based upon the fixed-dose schedule |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Traditional CBT 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. | 15 |
| 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). | 19 |
| Total | 34 |
Baseline characteristics
| Characteristic | Traditional CBT | Stepped-Care CBT | Total |
|---|---|---|---|
| Age, Continuous | 31.33 years STANDARD_DEVIATION 10.5 | 35.95 years STANDARD_DEVIATION 16.16 | 33.74 years STANDARD_DEVIATION 13.1 |
| Region of Enrollment United States | 15 participants | 19 participants | 34 participants |
| Sex: Female, Male Female | 7 Participants | 13 Participants | 20 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 1 / 18 |
| serious Total, serious adverse events | 0 / 12 | 0 / 18 |
Outcome results
Primary
Treatment-related Total Cost Estimates
total estimated costs calculated based upon the fixed-dose schedule
Time frame: Posttreatment
Population: Treatment completers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional CBT | Treatment-related Total Cost Estimates | 5222.80 dollars | Standard Deviation 1429.15 |
| Stepped-Care CBT | Treatment-related Total Cost Estimates | 3121.65 dollars | Standard Deviation 2826.93 |
Primary
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score
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.
Time frame: Pretreatment, Posttreatment, and 3-month follow-up
Population: Randomized participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Traditional CBT | Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score | Pretreatment | 26.00 units on a scale | Standard Deviation 5.54 |
| Traditional CBT | Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score | Posttreatment | 14.25 units on a scale | Standard Deviation 6.19 |
| Traditional CBT | Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score | 3-Month Follow-up | 15.75 units on a scale | Standard Deviation 6.4 |
| Stepped-Care CBT | Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score | Pretreatment | 24.47 units on a scale | Standard Deviation 5.54 |
| Stepped-Care CBT | Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score | Posttreatment | 15.16 units on a scale | Standard Deviation 5.54 |
| Stepped-Care CBT | Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score | 3-Month Follow-up | 13.87 units on a scale | Standard Deviation 6.26 |