Appalachian Mind Health Initiative

NCT04120285 | Completed DMC

• 1 other identifier: PCS-2017C3-9252
• Study Type: interventional
• Target: 1,280
• Locations: 1 country
• Sites: 7

Brief Summary

We propose to carry out a treatment experiment in which we evaluate the extent to which randomizing primary care clinicians have access to remote internet-based Cognitive Behavior Therapy (eCBT) in rural West Virginia (WV) and Kentucky (KY) will help improve treatment of patients with Major Depressive Disorder (MDD). WV and KY are two of the most rural states in America and mental health treatment resources are low; especially in rural parts of the state.

Conditions

Major Depressive Disorder

Keywords

Depression; eCBT

Outcome Measures

Primary Outcomes (1)

• RDQ-7

  Investigators will assess all study patients remission from depression with the Remission from Depression Questionnaire (RDQ-7) via self-report assessments at 16 week follow-up. Investigators will monitor patients at 26, 39, and 52 weeks to evaluate the long-term maintenance of remission (or recurrence). The RDQ-7 is a measure with 41 items. Items are reported on a 3-point rating scale (0=not at all or rarely true; 1 = sometimes; 2 = often or almost always true). The total scale score ranges from 0-82. Participants with a total score below or equal to 27 are considered in remission. Higher total scores reflect greater pathology.

  16-Week Follow-up

Secondary Outcomes (3)

• PROMIS Short Form v1.0 - Severity of Substance Use (past 30 days)

  16 week Follow-up

• Compliance with Antidepressant Medication Treatment

  16 week Follow-up

• SDM-Q-9

  52 week Follow-up

Study Arms (3)

Primary Care Treatment

NO INTERVENTION

The participant will receive treatment as usual as prescribed by the primary care physician for MDD.

Primary care treatment with eCBT

ACTIVE COMPARATOR

The participant will receive treatment as usual as prescribed by the primary care physician with the addition of eCBT for MDD.

Behavioral: remote internet-based cognitive behavior therapy (eCBT)

Primary care treatment with guided eCBT

ACTIVE COMPARATOR

The participant will receive treatment as usual as prescribed by the primary care physician with the addition of guided eCBT for MDD.

Behavioral: remote internet-based cognitive behavior therapy (eCBT)

Interventions

remote internet-based cognitive behavior therapy (eCBT) BEHAVIORAL

Provide access to online psychotherapy program to participants in rural WV areas at no expense to them.

Primary care treatment with eCBT; Primary care treatment with guided eCBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• seeking MDD treatment for the first time in the past 6 months (i.e., the beginning of a first or new course of treatment),
• appropriate for outpatient treatment,
• literate in English,
• has access to a smart phone, home computer or willing to travel to access a computer
• without hearing or vision or cognitive impairment that would interfere with research data collection
• without history of either bipolar disorder or non-affective psychosis.

Sponsors & Collaborators

• University of South Florida: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (7)

University of Lousiville Health

Louisville, Kentucky, 40202, United States

Location

Upper Kanawha Clinic

Cedar Grove, West Virginia, 25039, United States

Location

Minnie Hamilton Health Systems

Glenville, West Virginia, 26351, United States

Location

Minnie Hamilton Health Systems

Grantsville, West Virginia, 26147, United States

Location

Harpers Ferry Family Medicine

Harpers Ferry, West Virginia, 25425, United States

Location

WVU Medicine

Morgantown, West Virginia, 26505, United States

Location

Wayne Medical Clinic

Wayne, West Virginia, 25570, United States

Location

Related Publications (1)

• Bossarte RM, Kessler RC, Nierenberg AA, Chattopadhyay A, Cuijpers P, Enrique A, Foxworth PM, Gildea SM, Belnap BH, Haut MW, Law KB, Lewis WD, Liu H, Luedtke AR, Pigeon WR, Rhodes LA, Richards D, Rollman BL, Sampson NA, Stokes CM, Torous J, Webb TD, Zubizarreta JR. The Appalachia Mind Health Initiative (AMHI): a pragmatic randomized clinical trial of adjunctive internet-based cognitive behavior therapy for treating major depressive disorder among primary care patients. Trials. 2022 Jun 20;23(1):520. doi: 10.1186/s13063-022-06438-y.

  PMID: 35725644 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Robert Bossarte, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

• Ronald Kessler, PhD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participant recruiters will be blinded to the participant's intended treatment arm. Survey data collectors will be blinded to each participant's treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychiatry and Behavioral Neuroscience

Model Details: There are three treatment arms: 1) treatment as usual 2) treatment as usual with unguided eCBT and 3) treatment as usual with guided eCBT

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: October 9, 2019
• Study Start: January 9, 2021
• Primary Completion: December 31, 2025
• Study Completion: January 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)