Project EMPOWER-OCD

NCT07158801 | Not Yet Recruiting Phase 1

• 1 other identifier: 8178E
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Parental Accommodation; Obsessive-Compulsive Disorder; Caregiving; Single Session Interventions

Outcome Measures

Primary Outcomes (2)

• Family Accommodation Scale

  19-item measure designed to assess the child's OCD symptoms and the extent to which a caregiver accommodates a child's OCD symptoms. Only the part two of the measure will be used to get the report of family member's responses to OCD. Items are rated from 0 (never) to 4 (every day). Total sum score ranges from 0 to 76 with higher scores indicating more frequent parental accommodation.

  Change from baseline, 2-week follow-up, 4-week follow-up

• Children's Yale-Brown Obsessive Compulsive Scale

  A two-part measure with a checklist of common obsessions and compulsions as well as a 10-item part that asks participants to report on the severity of their child's OCD rated on a 0 (none) to 4 (extreme) scale. Total sum score ranges from 0 to 40 with higher scores indicating higher symptom severity.

  Change from baseline, 2-week follow-up, 4-week follow-up

Secondary Outcomes (3)

• Parental Stress Scale

  Change from baseline, 2-week follow-up, 4-week follow-up

• Program Feedback Scale

  Immediately after the SSI

• Perceived pre-to-post SSI change

  Immediately after the SSI

Other Outcomes (1)

• Consumer Financial Protection Bureau Financial Well-Being Scale

  Baseline

Study Arms (2)

Project EMPOWER-OCD

EXPERIMENTAL

Project EMPOWER-OCD is a web-based intervention for caregivers that takes about 20-25 minutes to complete that reduces accommodation.

Behavioral: Project EMPOWER-OCD

Project CARE

ACTIVE COMPARATOR

This active psychoeducation-based SSI will provide general information on caregiving and caregiver mental health.

Behavioral: Project CARE

Interventions

Project EMPOWER-OCD BEHAVIORAL

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 avoidance patterns; (3) information on how caregivers can better identify patterns of avoidance, validate, and encourage approach behaviors instead; (4) creation of an "action plan" to promote approach behavior and reducing avoidance; (5) a vignette exercise in which caregivers read about another case and provide possible solutions based on what they learned. Resources for finding mental health treatment for OCD are presented at the end.

Project EMPOWER-OCD

Project CARE BEHAVIORAL

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 on how caregiving looks like in their life (5) vignette exercise where caregivers identify caregiving roles, prompting reflection on roles. This active comparator intentionally does not include any psychoeducational components explicitly designed to reduce accommodation of anxiety, OCD, and its related disorders.

Project CARE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Central Study Contacts

Jenna Y Sung, Ph.D.

CONTACT

617-353-1503; jensung@bu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Access Criteria: Please contact the study PI for access

Locations

US (1)