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Project EMPOWER-OCD

B

Boston University Charles River Campus

Status and phase

Not yet enrolling
Phase 1

Conditions

Obsessive-Compulsive Disorder

Treatments

Behavioral: Project EMPOWER-OCD
Behavioral: Project CARE

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

This research study aims to adapt and evaluate the acceptability and effectiveness of Project EMPOWER-OCD for socioeconomically diverse caregivers of patients with OCD. Designed to reduce obstacles (e.g. months long time commitment, high cost, transportation) to treatment that caregivers may be particularly prone to, project EMPOWER-OCD will provide targeted intervention of accommodation - a well-established, potentially modifiable risk factor for child anxiety, OCD, and its related disorders - in a single, self-guided session via an online format.

Full description

The need for accessible, effective interventions for child OCD that meet the needs of financially insecure families can be addressed via mechanism-targeted single session interventions (SSIs). Unlike the dominant models of brick-and-mortar clinic based, multi-week psychotherapy, SSIs involve intentional, single visit or interaction with a clinic, provider, or self-guided program. To date, SSIs have prevented and reduced child psychopathology across numerous trials . Given that the modal number of therapy sessions completed across all care settings is one, SSIs leverage these one-time interactions to complement -rather than replace -the existing mental health care models to help address long-standing, multi-level barriers to care (e.g., lack of providers, long waitlists, and family's ability to attend multi-sessions).

In SSI development, it is critical to identify target mechanisms to optimize the likelihood of spurring clinical change in a short period of time. One way caregivers get further entangled in the webs of OCD is accommodation, which refers to changes in caregiving behaviors or routines that facilitate or maintain their child's avoidance or anxiety. Examples include modifying family routines (i.e. adjusting work schedules to ensure the child has enough time to complete rituals) or directly participating in a patient's avoidance strategies (i.e. repeatedly washing objects on behalf of a patient who has contamination fears). Accommodation reduces the patient's short-term distress but inadvertently maintains their long-term avoidance. High levels of family accommodation have consistently predicted the maintenance and severity of OCD problems. Moreover, as accommodation involves the act of doing more to alleviate the patient's distress in the short term, reducing this common caregiving behavior gives caregivers the permission to do less - not only removing a common maintenance factor of OCD, but also decreasing caregiver burden and stress, ultimately improving family well-being. Project EMPOWER is a self-administered SSI that has been evaluated in previous trials to successfully reduce accommodation in caregivers of anxious children.

This research study aims to adapt and evaluate the acceptability and effectiveness of Project EMPOWER-OCD for socioeconomically diverse caregivers of patients with OCD. Designed to reduce obstacles (e.g. months long time commitment, high cost, transportation) to treatment that caregivers may be particularly prone to, project EMPOWER-OCD will provide targeted intervention of accommodation - a well-established, potentially modifiable risk factor for child anxiety, OCD, and its related disorders - in a single, self-guided session via an online format. SSIs have been shown to produce benefits across a range of mental health conditions and access to the intervention may provide potential benefits to their emotional health and family functioning. There are no known risks to participate in this study

Enrollment

110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • be a caregiver for at least one individual with OCD, defined as living in the same household and providing daily care
  • be 18 years old or older
  • the individual they are caring for have clinically significant OCD symptoms, indicated by a score a 16 or above on the self-reported Children's Yale-Brown Obsessive Compulsive Scale - Parent Report (CY-BOCS-PR)
  • speak, read, and write English
  • not be in concurrent family-based CBT treatment for the patient's OCD.

Exclusion criteria

  • does not speak English
  • younger than 18 years old
  • participation in concurrent family-based CBT treatment for the patient's OCD.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

110 participants in 2 patient groups

Project EMPOWER-OCD
Experimental group
Description:
Project EMPOWER-OCD is a web-based intervention for caregivers that takes about 20-25 minutes to complete that reduces accommodation.
Treatment:
Behavioral: Project EMPOWER-OCD
Project CARE
Active Comparator group
Description:
This active psychoeducation-based SSI will provide general information on caregiving and caregiver mental health.
Treatment:
Behavioral: Project CARE

Trial contacts and locations

1

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Central trial contact

Jenna Y Sung, Ph.D.

Data sourced from clinicaltrials.gov

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