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Implementing and Evaluating an Internet-based Cognitive Behavior Therapy Intervention in School Settings

A Feasibility Study for Implementing and Evaluating an Internet-based Cognitive Behavior Therapy Intervention in School Settings and Its Impact on Adolescent Mental and Behavioral Health

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04928001
Enrollment
67
Registered
2021-06-16
Start date
2021-02-17
Completion date
2021-04-09
Last updated
2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression Anxiety and Co-occurring Rural Youth

Brief summary

This research study examines rural youth's experience of an internet based cognitive behavioral therapy intervention, and their experience of symptoms of depression, anxiety and co-occurring disorders.

Detailed description

In the United States, and rural Montana, a substantial health disparity exists for rural youths' mental health and mental health care access. In 2017, nearly a third of all Montana high school students reported being impacted by depression; 21% considered suicide compared to 17% nationally. Over 30% of Montana adolescents indicated drinking alcohol and 20% indicated using marijuana. Rural Montanans face enormous barriers to behavioral health care including low mental health care provider coverage, long distances to adequate care, and stigma. We have developed a culturally and developmentally appropriate Internet-based Cognitive Behavior Therapy (iCBT) program designed to teach skills that address mental and behavioral health challenges common to adolescents. Building on previous development and evaluation of an adult version of iCBT (Thrive), the investigators propose to pilot the newly developed youth version of Thrive (Y-T), a fully automated stand-alone program. Y-T will deliver CBT skills through educational, real life adolescent scenarios, and tailored feedback videos to address symptoms of depression, anxiety and co-occurring (addiction) behaviors. The investigators intend to conduct feasibility analyses of pilot study implementation in school communities. The investigators will document and assess organization-level facilitators and barriers that impact the study processes at each study site. Short-term goal for this research are to understand how to effectively conduct trials within school community settings and to obtain preliminary information on the acceptability and effectiveness of the Y-T program to address depression and anxiety symptoms, and addictive behaviors. The investigators will conduct post-intervention focus groups to assess the program as experienced by participants and insight on the extent of program engagement and learning. The investigators hypothesize that those using Y-T over an 8-week period will report markedly decreased scores on anxiety, depression, and addictive behaviors. The long-term goal is to conduct a larger trial of the program to determine the evidence of impact among youth. Provided that this research demonstrates such programs to be evidence-based, the investigators will work on a broader dissemination plan with the ultimate aim of decreasing mental and behavioral health and respective health care disparities among rural youth.

Interventions

OTHERinternet based iCBT program, Youth Thrive

iCBT program is a skills program which teaches assertive communication, constructive thinking and rewarding activities

Sponsors

Montana State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

multiple baseline pre-post design

Eligibility

Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
Yes

Inclusion criteria

* participants are youth enrolled in participating schools * ages 13 - 18 years old * have access to electronic device to access iCBT intervention

Exclusion criteria

* none.

Design outcomes

Primary

MeasureTime frameDescription
Beck's Anxiety Inventory, Youth Version8 weeksThe inventory measures anxiety symptoms and utilizes T Scores. 52.45 indicates the population mean with a standard deviation of 11.4 55 or less minimal, average symptoms of anxiety 55-59 mild symptoms of anxiety 60-69 moderate symptoms of anxiety 70+ severe symptoms of anxiety

Countries

United States

Participant flow

Participants by arm

ArmCount
Youth Thrive iCBT Program
Youth Thrive iCBT online program internet based iCBT program, Youth Thrive: iCBT program is a skills program which teaches assertive communication, constructive thinking and rewarding activities
67
Total67

Baseline characteristics

CharacteristicYouth Thrive iCBT Program
Age, Categorical
Anxiety Symptoms
<=18 years
67 Participants
Age, Categorical
Anxiety Symptoms
>=65 years
0 Participants
Age, Categorical
Anxiety Symptoms
Between 18 and 65 years
0 Participants
Age, Categorical
Depressive Symptoms
<=18 years
67 Participants
Age, Categorical
Depressive Symptoms
>=65 years
0 Participants
Age, Categorical
Depressive Symptoms
Between 18 and 65 years
0 Participants
Age, Categorical
Substance Use Attitudes & Behaviors
<=18 years
67 Participants
Age, Categorical
Substance Use Attitudes & Behaviors
>=65 years
0 Participants
Age, Categorical
Substance Use Attitudes & Behaviors
Between 18 and 65 years
0 Participants
Race and Ethnicity Not Collected— Participants
Region of Enrollment
United States
67 participants
Sex: Female, Male
Female
33 Participants
Sex: Female, Male
Male
34 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 67
other
Total, other adverse events
0 / 67
serious
Total, serious adverse events
0 / 67

Outcome results

Primary

Beck's Anxiety Inventory, Youth Version

The inventory measures anxiety symptoms and utilizes T Scores. 52.45 indicates the population mean with a standard deviation of 11.4 55 or less minimal, average symptoms of anxiety 55-59 mild symptoms of anxiety 60-69 moderate symptoms of anxiety 70+ severe symptoms of anxiety

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
Youth Thrive iCBT ProgramBeck's Anxiety Inventory, Youth Version52.45 T ScoreStandard Deviation 11.4
p-value: 0.0195% CI: [0, 60]t-test, 1 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026