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Recruiting NCT07158801

Project EMPOWER-OCD

No phase Interventional Obsessive-Compulsive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Project EMPOWER-OCD, Project CARE.
Who it may be relevant to
Registry conditions: Obsessive-Compulsive Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Web-based Single Session Intervention to Reduce Caregiver Distress and Accommodation in Socioeconomically Diverse Caregivers of OCD Patients

Overview

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.

Detailed 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

Interventions

  • Behavioral Project EMPOWER-OCD
    Project EMPOWER-OCD is a web-based intervention for caregivers that takes about 20-25 minutes to complete that reduces accommodation. The program is drawing from an empirically supported intervention, Project EMPOWER, and will be adapted for the OCD population pending stakeholder input during phase 1 and include 5 elements: (1) an introduction to the program's rationale; (2) psychoeducation around OCD-driven avoidance, along with how caregiver accommodation can inadvertently maintain these avoid
  • Behavioral Project CARE
    To evaluate the effects of Project EMPOWER-OCD, we will compare it to an active psychoeducation-based SSI that provides general information on caregiving and caregiver mental health. The intervention includes 5 elements that mirror Project EMPOWER: (1) introduction to the rationale for the program; (2) introduce the concept of caregiving across relationships and situations; (3) present broad information on typical development processes; (4) helping caregivers identify their own role and reflect

Primary outcome measures

  • Family Accommodation Scale [Time frame: Change from baseline, 2-week follow-up, 4-week follow-up]
  • Children's Yale-Brown Obsessive Compulsive Scale [Time frame: Change from baseline, 2-week follow-up, 4-week follow-up]
Secondary outcome measures (3)
  • Parental Stress Scale [Time frame: Change from baseline, 2-week follow-up, 4-week follow-up]
  • Program Feedback Scale [Time frame: Immediately after the SSI]
  • Perceived pre-to-post SSI change [Time frame: Immediately after the SSI]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Boston University — Boston

Identifiers

NCT: NCT07158801 · 8178E

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗