Obsessive-Compulsive DisorderNCT07158801
Project EMPOWER-OCD
A study testing Project EMPOWER-OCD and Project CARE in people with Obsessive-Compulsive Disorder, run by Boston University Charles River Campus at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Project EMPOWER-OCD and Project CARE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- does not speak English
- younger than 18 years old
- participation in concurrent family-based CBT treatment for the patient's OCD.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston University
Boston, Massachusetts, 02215
Jenna Y Sung, Ph.D., 617-353-1503, Jensung@bu.edu
About this study
Official title: A Web-based Single Session Intervention to Reduce Caregiver Distress and Accommodation in Socioeconomically Diverse Caregivers of OCD Patients
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.
Read the 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
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Project EMPOWER-OCD, Project CARE
- Keywords
- Parental Accommodation, Obsessive-Compulsive Disorder, Caregiving, Single Session Interventions
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project EMPOWER-OCDBehavioural
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 CAREBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Project EMPOWER-OCD |
| Project CARE | Active comparator | This active psychoeducation-based SSI will provide general information on caregiving and caregiver mental health. Receives: Behavioral: Project CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline, 2-week follow-up, 4-week follow-up
Secondary outcomes (3)
Parental Stress Scale
An 18-item measure of caregiving stress levels, rated on a scale of 1 (strongly disagree) to a 5 (strongly agree) scale on their perceived positive and negative experience of being a caregiver
Measured: Change from baseline, 2-week follow-up, 4-week follow-up
Program Feedback Scale
The program feedback scale asks participants to rate 7 statements regarding acceptability and feasibility; note whether they would recommend this activity to others; and share what they liked and would change about the SSI. The 7 statements are rated from 0 (Really Disagree) to 5 (Really Agree). Total score ranges from 0 to 35, with higher scores indicating a more positive program evaluation.
Measured: Immediately after the SSI
Perceived pre-to-post SSI change
a 2-item measure assesses participants' perceived change in their ability to help their children manage distressing situations from pre- to post-SSI: "compared to before you completed this program, how prepared do you feel to help your child manage distressing situations?" Participants in both groups will rate this question on a 5- point scale of 1 (much less able to help) to 5 (much more able to help).
Measured: Immediately after the SSI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start25 Mar 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158801
- Sponsor's protocol ID
- 8178E
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Web-based Single Session Intervention to Reduce Caregiver Distress and Accommodation in Socioeconomically Diverse Caregivers of OCD Patients
- ClinicalTrials.gov ID
- NCT07158801
- Acronym / sponsor ID
- 8178E
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Parental Accommodation, Obsessive-Compulsive Disorder, Caregiving, Single Session Interventions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project EMPOWER-OCD | Experimental | Behavioral: Project EMPOWER-OCDProject EMPOWER-OCD is a web-based intervention for caregivers that takes about 20-25 minutes to complete that reduces accommodation. |
| Project CARE | Active comparator | Behavioral: Project CAREThis active psychoeducation-based SSI will provide general information on caregiving and caregiver mental health. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- does not speak English
- younger than 18 years old
- participation in concurrent family-based CBT treatment for the patient's OCD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project EMPOWER-OCDProject 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. | Behavioural | Project EMPOWER-OCD |
| Project CARETo 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. | Behavioural | Project CARE |
Primary outcome
Family Accommodation Scale
Time frame: Change from baseline, 2-week follow-up, 4-week follow-up
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.
Children's Yale-Brown Obsessive Compulsive Scale
Time frame: Change from baseline, 2-week follow-up, 4-week follow-up
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project EMPOWER-OCD and Project CARE in people with Obsessive-Compulsive Disorder, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenna Y Sung, Ph.D. (617-353-1503, jensung@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Accommodation Scale (time frame: Change from baseline, 2-week follow-up, 4-week follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.