Clinical trial NCT05462652: Self-guided Treatment for Adolescents Navigating Depression
Official title: Project STAND (Self-guided Treatment for Adolescents Navigating Depression): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Depression
Depressive Disorder
Depressive Episode
Keywords: Mental Health
Adolescents
Depression
Adolescent Mental Health
Lead sponsor: Limbix Health, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 223
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to test whether an investigational mobile app can be a helpful treatment option for adolescents with symptoms of depression. Adolescents aged 13 to 21 with depression symptoms can be part of this study if eligible.

Eligible participants will be randomly assigned to one of two groups: one group will receive the mobile app intervention in addition to their usual care and the other group will simply continue their usual care for symptoms of depression. Both groups will have 5 weeks to use a study app, and will complete assessments during the intervention period, at post-intervention, and at one month follow-up.

Detailed description: The primary aim of the proposed research is to evaluate the effectiveness of a self-guided, cognitive behavioral therapy (CBT)-based mobile app + assessment-enhanced Usual Care (eUC) compared to eUC alone as an intervention for adolescents with symptoms of depression who are under the supervision of a licensed healthcare provider.

The sample size for this study is 220 subjects. Sample size calculation is based on primary outcome patient health questionnaire (PHQ-8) at post-intervention (5 weeks). Six PHQ-8 measurements will be collected from each subject (baseline and weekly during the 5-week intervention period). Using a two-sample t-test approach, assuming a two-tailed alpha set at 0.05, a total of 200 participants (100 in each study arm) will give us 80% power to detect a moderate effect size of at least d=0.4. Given an anticipated 10% rate of attrition, we aim to enroll 220 total participants in the study.

A 50% female sample will be targeted. Earlier recruitment efforts within the study demographic have resulted in majority female samples, consistent with prevalence rates within the study population. As such, recruitment efforts will be undertaken to ensure representation of male participants. Recruitment efforts will be taken to ensure adequate representation of underrepresented racial and ethnic minority groups.

Children between the ages of 13-17 will be included in this research as the program to be evaluated is specifically designed as an intervention for adolescents with symptoms of depression. Assent will be obtained from all children under 18 for study enrollment unless legally emancipated or financially independent in accordance with CA state regulations and regulations of the state in which the minor resides.

Study staff will monitor participants' symptom deterioration and questionnaire data for safety.

Eligibility criteria: Inclusion Criteria:

* 13-21 years of age
* PHQ-8 score ≥ 5 at eligibility screening
* English fluency and literacy (participant and legal guardian, if applicable)
* Access to a compatible smartphone (or other device) and operating system (i.e., capable of installing the app from the Google Play or Apple App Store; list will be provided on study website) and regular internet access
* Participant willing and able to provide informed consent/assent and have legal guardian willing and able to provide informed consent (if required)
* Under the care of a United States (U.S.)-based licensed healthcare provider and willing to provide contact information for the provider and sign a HIPAA release that allows Limbix to contact provider
* Willing and able to provide information required for study enrollment (e.g. all responses to initial PHQ-8 assessment, and current antidepressant medication status)
* Located in the continental U.S., Hawaii, or Alaska, and not planning to leave the U.S. during the study period (through 1-month follow up assessments, up to 11 weeks after eligibility screening)

Exclusion Criteria:

* Diagnosis of (or treatment for) bipolar disorder, post traumatic stress disorder, psychotic disorder, substance use disorder, or eating disorder within the 12 months prior to eligibility screening
* Change in psychotropic medication (initiation or change in dose) within the 30 days prior to eligibility screening
* Plans to initiate or change treatment (e.g., psychotherapy, psychotropic medication, and/or other psychosocial treatment) for a mental health disorder during the study intervention period (5 weeks) as determined at eligibility screening
* Suicide attempt within the past year
* Active suicide ideation with intent
* Previous participation in user testing or clinical testing of Spark or SparkRx, or other previous use of SparkRx app
* Participation in any other clinical research involving a mental health intervention or treatment within 60 days prior to eligibility screening
* Plans to participate in any other clinical research involving a mental health intervention or treatment during the study intervention period (5 weeks) as determined at eligibility screening
* Any condition, comorbidity, or event that, in the opinion of the investigator, will prevent the participant from adhering to the protocol or benefitting from the intervention or will prevent investigators from being able to ensure safety
* Having a sibling who is a past or current participant in the study

Primary outcomes:
measure: Depressive Symptom Severity at Post-intervention
timeFrame: Post-intervention (5 week timepoint)
Secondary outcomes:
measure: Intervention Response at Post-intervention
timeFrame: Change from baseline to post-intervention (5 weeks)
measure: Remission at Post-intervention
timeFrame: Post-intervention (5 week timepoint)
measure: Clinically-meaningful Reduction in Severity at Post-intervention
timeFrame: Change from baseline to post-intervention (5 weeks)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Limbix Health, Inc.
state: California
Study officials:
affiliation: Limbix Health, Inc.
name: Aarthi Padmanabhan, PhD
role: PRINCIPAL_INVESTIGATOR
References: