Obsessive-compulsive Disorder Clinical Trial
Official title:
Stepped Care for Obsessive-Compulsive Disorder
This study will determine the effectiveness and cost-effectiveness of a stepped-care treatment program for people with obsessive-compulsive disorder.
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.
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