NCT03244878

Brief Summary

This study evaluates a culturally-modified version of Thrive, a computerized Cognitive Behavior Therapy program to treat depressive symptoms, syndromes, and disorders among rural Montanans. Study participants will be randomized to either a wait-list treatment as usual or the Thrive program. After 8 weeks, the wait-list group will then receive Thrive. The primary assessment measure is the Patient Health Questionnaire-9.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
464

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

9 months

First QC Date

August 3, 2017

Last Update Submit

August 12, 2018

Conditions

Keywords

Cognitive Behavior Therapy

Outcome Measures

Primary Outcomes (1)

  • Patient Health Questionnaire-9

    Clinical measure of depressive symptom severity. Self-reported with a score range from 0 to 3 (not at all to nearly every day)

    2 weeks

Secondary Outcomes (3)

  • Generalized Anxiety Disorder-7

    2 weeks

  • Work and Social Adjustment Scale

    1 year

  • Connor-Davidson Resilience Scale

    1 month

Study Arms (2)

Intervention - Thrive program

EXPERIMENTAL

Participants will receive access to the Thrive program for 8 weeks

Behavioral: Thrive

Wait-list Control

NO INTERVENTION

Participants will have no access to the Thrive program for 8 weeks upon enrollment. They will receive a link to the NIMH website to read about information on depression.

Interventions

ThriveBEHAVIORAL

A interactive computerized program using structured content of cognitive behavior therapy

Intervention - Thrive program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older
  • Baseline PHQ-9 score of 5 or greater
  • Montana resident
  • Regular access to broadband internet (streaming capability)

You may not qualify if:

  • No broadband internet access
  • Aged 17 years or younger
  • Does not have Montana residency
  • Baseline PHQ-9 score of \< 5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montana State University

Bozeman, Montana, 59717, United States

Location

Related Publications (2)

  • Schure M, McCrory B, Tuchscherer Franklin K, Greist J, Weissman RS. Twelve-Month Follow-Up to a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention for Rural Adults With Depression Symptoms: Single-Arm Longitudinal Study. J Med Internet Res. 2020 Oct 2;22(10):e21336. doi: 10.2196/21336.

  • Schure MB, Lindow JC, Greist JH, Nakonezny PA, Bailey SJ, Bryan WL, Byerly MJ. Use of a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention in a Community Population of Adults With Depression Symptoms: Randomized Controlled Trial. J Med Internet Res. 2019 Nov 18;21(11):e14754. doi: 10.2196/14754.

MeSH Terms

Conditions

Depression

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomized to either the wait-list controlled group or intervention group. Intervention period is 8 weeks. Data collection occurs at baseline, 4 weeks, and 8 weeks, with longer-term follow-up assessments.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 10, 2017

Study Start

May 1, 2017

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

August 14, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations