Project Summary
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Feeling anxious is a normal way to react to stressful events or situations. But youth with an anxiety disorder have fear, worry, or nervousness that may keep them from doing their regular daily activities. Obsessive-compulsive disorder, or OCD, is a type of anxiety disorder. People with OCD have uncontrollable and repeated thoughts and behaviors. Cognitive behavioral therapy, or CBT, is the preferred treatment for anxiety and OCD. With CBT, patients learn to change their patterns of thinking and behaving. Usually, people go to an office or clinic to get CBT from mental health specialists like psychologists.
In this study, the research team is comparing two ways to provide CBT treatment for youth with anxiety or OCD. The first is CBT at a psychologist’s office. The second is CBT at a psychologist’s office and at the patient’s home. The team is looking at how well these treatments work to improve patients’ symptoms and quality of life.
Who can this research help?
Mental health clinicians can use results from this study when planning how to care for youth with anxiety or OCD.
What is the research team doing?
The research team is recruiting 333 youth ages 5 to 18 in Rhode Island. Patients must have had symptoms of anxiety or OCD for at least three months before starting the study. Patients must also have a parent or caregiver who can participate in treatment.
The research team is assigning patients by chance to one of two treatment groups:
- Office-based CBT. Patients see a psychologist in an office for 60-minute CBT treatments four times a month for six months.
- Home-based CBT. Patients see a psychologist in an office for 60-minute CBT treatments once a month for six months. Patients also get a 90-minute home visit with a trained mobile exposure coach three times a month for six months. Coaches have a bachelor’s degree and receive training from psychologists on treating youth with anxiety and OCD. These coaches help patients get the mental health care they need. The treating psychologist supervises the coaches through weekly meetings.
The research team is using interviews and surveys to ask patients and parents about anxiety and OCD symptoms. They also ask about quality of life and satisfaction with mental health services. Patients and parents answer questions at the start of the study and every six weeks for six months. They also answer questions three and six months later.
Patients, families, health insurers, and health system administrators are working with the research team to plan and conduct the study.
Research methods at a glance
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 333 youth ages 5 to 18 diagnosed with anxiety or OCD who have had symptoms for at least 3 months before starting the study |
| Interventions/ Comparators |
|
| Outcomes |
Primary: anxiety symptoms and severity, OCD symptoms and severity Secondary: family engagement with treatment, family satisfaction with mental health services, quality of life, functional impairment, caregiver burden, family accommodation, barriers to treatment access, time course of response to treatment, durability of treatment gains, provider volume and capacity, efficiency in treatment |
| Timeframe | Up to 6-month follow-up for primary outcomes |
COVID-19-Related Study
Using Team-Based Behavioral Therapy by Telehealth to Treat Youth with Anxiety and Obsessive-Compulsive Disorder
Results Summary
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
What was this COVID-19 study about?
Youth with anxiety disorders may feel fear, worry, or nervousness that keeps them from daily activities. Obsessive-compulsive disorder, or OCD, is a type of anxiety disorder. The COVID-19 pandemic may have increased anxiety or OCD symptoms among youth. Cognitive behavioral therapy, or CBT, can treat anxiety and OCD. In CBT, patients learn to change patterns in thinking and behavior. In team-based CBT, licensed therapists provide CBT in a team with non-licensed coaches.
In response to the pandemic, many health centers moved from in-person care to telehealth. Telehealth is a way to provide care to patients remotely using phone or video. Treatment with team-based CBT by telehealth can widen the opportunities for youth to receive therapy.
In this study, the research team tested team-based telehealth CBT for youth with anxiety or OCD during the pandemic.
Youth received up to six months of weekly video sessions with CBT providers. Youth met with a psychologist monthly and a coach with a college degree all other weeks. The research team looked at treatment and mental health outcomes reported by youth, their caregivers, and the CBT providers.
What were the results?
On average, youth attended 19 of 24 telehealth sessions. Youth reported a moderate to strong connection with CBT providers; caregivers reported a strong connection. Youth and caregivers were satisfied with their care.
Results showed that, after youth received team-based telehealth CBT:
- Youth and CBT providers reported that anxiety symptoms improved.
- CBT providers reported that OCD symptoms improved, but youth didn’t report this change.
- Caregivers reported improvement in youth quality of life, but youth didn’t report this change.
- Youth reported an improvement in their ability to do daily activities, but caregivers didn’t report this change.
Who was in the study?
The study included 46 youth ages 5–18 and their caregivers. Among youth, 87 percent were White; 2 percent were Black; 2 percent were Asian; 3 percent were Hawaiian, Pacific Islander, or Alaska Native; and 7 percent were multi-racial; 9 percent were Hispanic. The average age was 11, and 50 percent were girls. All youth received care at the Pediatric Anxiety Research Center in Rhode Island.
What did the research team do?
The research team enrolled youth with anxiety or OCD to receive team-based CBT by telehealth. Youth, their caregivers, and CBT providers completed surveys before treatment, every six weeks during treatment, and one to two weeks after treatment.
Youth with anxiety or OCD, family members, hospital leaders, therapists, patient advocates, and insurers gave input on the study design.
What were the limits of the study?
The study was small; most youth were White. Findings may have differed if the study had included more youth or youth from other racial backgrounds. The study didn’t look at how well telehealth worked compared with no care or usual mental health care. As a result, the research team can’t say for sure if the changes were due to the team-based telehealth CBT or something else.
How can people use the results?
Health centers can use the results when considering ways to offer CBT for youth with anxiety and OCD.
Professional Abstract
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
Background
For youth with anxiety or obsessive-compulsive disorder (OCD), lack of mental health providers can limit access to cognitive behavioral therapy (CBT). The COVID-19 pandemic led to a shift toward telehealth. Team-based telehealth CBT could expand access to mental health care by increasing the availability of providers and facilitating access to treatment at a time when anxiety and OCD symptoms among youth have increased.
Objective
To describe how team-based telehealth CBT affected treatment engagement and mental health outcomes among youth with anxiety or OCD
Study Design
| Design Element | Description |
|---|---|
| Design | Descriptive non-randomized study that complements an ongoing RCT comparing 2 ways to provide CBT |
| Population | 46 youth ages 5–18 with anxiety or OCD diagnosis and 46 caregivers |
| Outcomes |
Treatment engagement, including treatment attendance and session homework completion Youth- and caregiver-reported outcomes: therapeutic alliance (bond and collaboration with therapist), treatment satisfaction, anxiety and OCD symptoms, quality of life and disability associated with symptoms CBT provider-reported outcomes: anxiety and OCD symptoms, functional impairment |
| Data Collection Timeframe | June 2020–July 2021 |
This study, complementing an ongoing randomized controlled trial (RCT), examined team-based CBT via telehealth for youth with anxiety or OCD.
In the ongoing RCT, researchers are comparing in-person, team-based CBT versus standard care with a psychologist for youth with anxiety or OCD. Due to COVID-19, researchers temporarily halted recruitment to two in-person treatment arms in spring 2020 and opened enrollment to team-based telehealth CBT.
Youth received up to six months of weekly telehealth CBT to manage anxiety or OCD. Youth met with a psychologist monthly and a coach, who had a college degree and additional training, all other weeks.
At baseline, every six weeks during treatment, and one to two weeks after treatment, youth, caregivers, and the psychologists and coaches who provided CBT completed surveys. Youth and caregivers completed surveys about therapeutic alliance, treatment satisfaction, symptoms, quality of life, and disability. CBT providers completed surveys about symptoms and functional impairment.
The study included 46 youth ages 5–18 with anxiety or OCD and their caregivers. All youth received treatment through the Pediatric Anxiety Research Center in Rhode Island. Among youth, 87% were White; 2% were Black; 2% were Asian; 3% were Hawaiian, Pacific Islander, or Alaska Native; and 7% were multi-racial; 9% were Hispanic. The average age was 11, and 50% were female.
Patients, family members, hospital leadership, therapists, patient advocates, and insurers provided input on study design.
Results
On average, youth completed 19 of 24 treatment sessions. Youth reported moderately strong therapeutic alliance (38.4 of 48 points), while caregivers reported strong alliance (45 of 48 points). Youth and caregivers generally reported high treatment satisfaction.
From baseline to posttreatment:
- For anxiety, youth and clinicians reported a decrease in symptoms (both p<0.001).
- For OCD, CBT providers reported a decrease in symptoms (p<0.001). Youth also reported a decrease in symptoms, but the decrease was not clinically meaningful.
- Caregivers reported an improvement in youths’ quality of life (p=0.02), but youth did not.
- Caregivers did not report a decrease in youth disability, but youth did (p=0.006).
Limitations
The sample size was small, and most participants were White, limiting generalizability of results. Without a comparison, this study cannot establish, with certainty, that changes from before to after the team-based telehealth CBT were due to this intervention.
Conclusions and Relevance
This study suggested effectiveness of team-based telehealth CBT for youth with anxiety and OCD. Having coaches with a college education supervised by a psychologist provide telehealth CBT may help expand access to mental health care.
Peer Review Summary
The Peer-Review Summary for this COVID-19 study will be posted here soon.
Final Enhancement Report
This COVID-19 study's final enhancement report is expected to be available by August 2023.