NCT03595254

Brief Summary

This study evaluates the efficacy of Thrive, a computerized cognitive behavior therapy program, to reduce depression and anxiety symptoms and to reduce suicidal thinking among adults. The first 450 participants will participate in a randomized waitlist controlled trial. The remaining 550 participants will be provided the program immediately upon enrolling

Trial Health

87
On Track

Trial Health Score

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

Enrollment
725

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

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

First Submitted

Initial submission to the registry

June 29, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

November 16, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2020

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

1.4 years

First QC Date

June 29, 2018

Last Update Submit

August 31, 2020

Conditions

Suicidal IdeationDepressionAnxiety

Outcome Measures

Primary Outcomes (1)

  • Concise Health Risk Tracking

    Suicidal Thinking; Score range 7 (better) - 35(worse)

    2 Weeks

Secondary Outcomes (4)

  • Generalized Anxiety Disorder Scale-7

    2 Weeks

  • Work and Social Adjustment Scale

    1 Year

  • Connor-Davidson Resilience Scale - Abbreviated Version

    1 month

  • Patient Health Questionnaire-9

    2 Weeks

Study Arms (2)

Thrive Intervention

EXPERIMENTAL

Online cognitive behavior therapy program

Behavioral: Thrive

Waitlist Control

NO INTERVENTION

Wait 8 weeks before receiving program access

Interventions

ThriveBEHAVIORAL

Computerized Cognitive Behavior Therapy program

Also known as: Thrive-Montana
Thrive Intervention

Eligibility Criteria

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

You may qualify if:

  • Montana resident
  • + years old
  • Have regular access to broadband internet
  • PHQ-9 score greater than 4

You may not qualify if:

  • No Montana residency
  • \< 18 years old
  • No broadband internet access
  • PHQ-9 score less than 5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montana State University

Bozeman, Montana, 59717-2940, United States

Location

MeSH Terms

Conditions

Suicidal IdeationDepressionAnxiety Disorders

Interventions

Nicotine

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehaviorMental Disorders

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: randomized waitlist controlled trial (first ?? participants) Open trial (following ?? participants)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 29, 2018

First Posted

July 23, 2018

Study Start

November 16, 2018

Primary Completion

April 8, 2020

Study Completion

April 8, 2020

Last Updated

September 2, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)