Supporting Peer Interactions to Expand Access to Digital Cognitive Behavioral Therapy for Spanish-speaking Patients

Depression, Anxiety Clinical Trial

— SUPERA  

Official title:

SUPERA: Supporting Peer Interactions to Expand Access to Digital Cognitive Behavioral Therapy for Spanish-speaking Safety-Net Patients in Primary Care

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05746767
• Other study ID #: 1856
• Secondary ID: R01MH126664
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 14, 2024
• Est. completion date: March 1, 2027

Study information

• Verified date: May 2024
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators will evaluate the implementation of an evidence-based, Spanish-language, digital, cognitive-behavioral therapy intervention (SilverCloud) in primary care settings for Latino patients with depression and/or anxiety. 426 participants will be enrolled in a two-armed trial comparing self-guided vs. supported dCBT (SilverCloud). At the provider level, investigators will compare the efficacy of provider referrals with the use of a clinic patient registry to identify candidates who could benefit from a digital mental health intervention.

Description:

The investigators will evaluate the implementation of an evidence-based, Spanish language, digital cognitive-behavioral therapy (dCBT) intervention (SilverCloud) in safety-net primary care clinics for Limited English Proficiency (LEP) Latinx patients with depression and/or anxiety. An effectiveness-implementation hybrid trial (Type 2) design with both provider and patient-level randomization will be conducted. At the provider-level the investigators will compare outreach (using the clinic patient registry) with inreach (traditional provider referral), at the patient-level two modes of delivery of the dCBT platform - supported and unsupported will be compared.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 426
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. PHQ-9 = 10 or GAD-7 = 8

2. Has access to the Internet via smartphone and/or broadband at home, and basic level of technological literacy or willingness to undergo a brief technology use training

3. =18 years of age

4. Preference for receiving medical care in Spanish

5. Not in concurrent psychotherapy

6. If currently taking an antidepressant medication, patient must have been on a stable dose for at least 6 weeks, and have no plans to change the dose. We will permit patients on antidepressants to enter the study, as this will increase generalizability. Antidepressant status will be monitored at each assessment to control for those effects, if necessary.

Exclusion Criteria:

1. Currently receiving psychotherapy, as this treatment will be offered as a frontline treatment for depression and anxiety, however, patients are allowed to be referred to treatment while participating in this study and initiation of treatment will be monitored and considered in analyses

2. Visual, hearing, voice, or motor impairment or illiteracy that would prevent completion of study procedures

3. Diagnosis of a psychotic disorder, bipolar disorder, dissociative disorder, or substance use disorder

4. Severe suicidality (as assessed by expressing suicidal ideation, plan, and intent). Although procedures with back-up plans are in place for patients who develop suicidality (see Human Subjects Section), patients assessed with severe suicidality will be referred to more-intensive treatment resources.

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety

Intervention

Behavioral:
• Supported dCBT
In the supported dCBT condition, each patient will receive complete access to the SilverCloud platform. In addition, patients will be assigned a supporter who will provide regular support based on an established coaching support protocol. Supporters will conduct a brief engagement call (30-40 minutes) to provide an overview of SilverCloud, identify goals, and set expectations, introduce themselves, and orient the participant to the role of the peer supporter. Supporters will then provide weekly check-ins through phone calls or messaging. Participants will be able to communicate with the supporters through the platform through messaging or sharing activities for additional discussion. The major goal of the support is to promote use of the platform.
• Unsupported dCBT
Unsupported dCBT provides all features of the SilverCloud platform with the exception of support features (structured interactions with supporter and share features). Patients will be provided complete access to SilverCloud and instructed to use it for 8-weeks. Patients will receive weekly automated messages to encourage engagement.

Locations

Country	Name	City	State
United States	University of California	Berkeley	California
United States	University of California	Irvine	California
United States	Zuckerberg San Francisco General	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Irvine	National Institute of Mental Health (NIMH), University of California, Berkeley, University of California, San Francisco

Country where clinical trial is conducted

United States, 

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* Note: There are 110 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Frequency of Applying CBT-Based Skills at 8 Weeks	Frequency of Actions and Thoughts Scale (FATS). A 12-item measure that will be used to assess how frequently the participants apply CBT-based skills. Higher score means that the respondent has higher frequency of applying the CBT-based skills they learned.	Change from Baseline to Week 8
Other	Change in Knowledge of CBT at 8 Weeks	Knowledge Gain in CBT. A 16-item survey that will be used to assess changes in knowledge about CBT therapy. Higher score means that the respondent has higher knowledge of CBT skills.	Change from Baseline to Week 8
Other	Change in Psychological Well-Being	Psychological Well-Being will be assessed with the Brief Inventory of Thriving (BIT) a 10-item self-report measure. Scores on this measure range from 5 (low level of thriving) to 50 (high level of thriving).	Change from Baseline to Week 8
Other	Change in Stress at 8 Weeks	Stress will be assessed with the Perceived Stress Scale (PSS-4) a 4-item self-report measure that assesses feelings and thoughts that people are experiencing related to their experience of stress. Scores on this measure range from 0 (no perceived stress) to 16 (high perceived stress).	Change from Baseline to Week 8
Primary	Change in Depression at 8 Weeks	The primary outcome of symptoms of depression will be measured with the self-report Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report measure of depression. Scores on this measure range from 0 (Not At All) to 3 (Nearly Every Day).	Change from Baseline to Week 8
Primary	Change in Anxiety at 8 Weeks	The primary outcome of symptoms of depression will be measured with the self-report General Anxiety Disorder-7 (GAD-7). The GAD-7 is a 7-item self-report measure of anxiety. Scores on this measure range from 0 (Not At All) to 3 (Nearly Every Day).	Change from Baseline to Week 8
Secondary	Change in Functioning at 8 Weeks	Functioning will be assessed with the World Health Organization Disability Assessment Schedule (WHODAS) a 36-item self-report measure that assesses disability across six domains, including understanding and communicating, getting around, self-care, getting along with people, life activities (i.e., household, work, and/or school activities), and participation in society. Scores on this measure range from 1 (none) to 5 (extreme).	Change from Baseline to Week 8
Secondary	Platform Usage	Platform usage will be defined as time spent on the platform. Platform usage will vary from 0 minutes to the highest number of minutes any participants spends on the platform.	Total platform usage from baseline to Week 8