Clinical trial NCT04928001: Implementing and Evaluating an Internet-based Cognitive Behavior Therapy Intervention in School Settings
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression Anxiety and Co-occurring Rural Youth
Lead sponsor: Montana State University
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 67
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: multiple baseline pre-post design
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Beck's Anxiety Inventory, Youth Version
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: Montana State University
state: Montana
Study officials:
References:
citation: Franklin K, Tribbit T. A Feasibility Study for Implementing and Evaluating an Internet-Based Cognitive Behavior Therapy Intervention in Rural School Settings and its Impact on Adolescent Mental and Behavioral Health. Chronicle of Rural Education. 2024; 2(1).