Suicidal IdeationTM2NCT03595254
Digital Cognitive Behavior Therapy Program for Suicide Prevention
A study testing Thrive in people with Suicidal Ideation and Depression, run by Montana State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicidal Ideation, Depression, Anxiety
- What is being tested?
- Thrive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 725 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2018to 8 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Montana resident
- 18+ years old
- Have regular access to broadband internet
- PHQ-9 score greater than 4
Who cannot join
- No Montana residency
- < 18 years old
- No broadband internet access
- PHQ-9 score less than 5
Trial locations and contacts
1 site in 1 country.
United States1 site
Montana State University
Bozeman, Montana, 59717-2940
About this study
Official title: Thrive-Montana: A Computerized Cognitive Behavior Therapy (cCBT) Program to Reduce Depression, Anxiety, Suicidal Ideation and Behaviors for Rural Montanans
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
Read the detailed description
The efficacy of Thrive has been studied among patient and community populations and has shown to effectively reduce depression and anxiety symptoms among adults with moderate to severe depression symptoms at baseline.
This study will examine whether Thrive can also reduce suicidal thinking for persons exhibiting at least moderate depression symptoms. The first phase of the study will implement a randomized waitlist controlled trial. The second phase of the study will examine the effects in a open trial. Outcome assessments will occur at baseline, 4- and 8-weeks (12- and 16-weeks for the waitlist group) with a 6-month follow-up assessment for all participants.
- Conditions
- Suicidal Ideation, Depression, Anxiety
- Being tested
- Thrive
- Medical subject headings
- Suicidal Ideation, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThriveBehavioural
Also called Thrive-Montana
Computerized Cognitive Behavior Therapy program
| Study group | Role | What they receive |
|---|---|---|
| Thrive Intervention | Experimental | Online cognitive behavior therapy program Receives: Behavioral: Thrive |
| Waitlist Control | No intervention | Wait 8 weeks before receiving program access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concise Health Risk Tracking
Suicidal Thinking; Score range 7 (better) - 35(worse)
Measured: 2 Weeks
Secondary outcomes (4)
Generalized Anxiety Disorder Scale-7
Anxiety symptoms; Score range 0 (better) to 21 (worse)
Measured: 2 Weeks
Work and Social Adjustment Scale
Functioning; Score range 0(better) - 40(worse)
Measured: 1 Year
Connor-Davidson Resilience Scale - Abbreviated Version
Resilience; score range 0 (worse) - 40(better)
Measured: 1 month
Patient Health Questionnaire-9
Depression; Score range 0(better) - 27(worse)
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start16 Nov 2018
- Primary completion8 Apr 2020
- Study completion8 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized waitlist controlled trial (first ?? participants) Open trial (following ?? participants)
- Masking
- None (open label)
- Enrolment
- 725 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Collaborators
- Montana Department of Public Health and Human Services
- Responsible party
- Principal investigator, Mark B. Schure, Ph.D., Montana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595254
- Sponsor's protocol ID
- MSchure
- Acronym
- TM2
- Status last verified
- Aug 2020
- First submitted
- 29 Jun 2018
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrive-Montana: A Computerized Cognitive Behavior Therapy (cCBT) Program to Reduce Depression, Anxiety, Suicidal Ideation and Behaviors for Rural Montanans
- ClinicalTrials.gov ID
- NCT03595254
- Acronym / sponsor ID
- TM2 / MSchure
- Conditions
- Suicidal Ideation, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 725 participants (actual)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Collaborators
- Montana Department of Public Health and Human Services
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The efficacy of Thrive has been studied among patient and community populations and has shown to effectively reduce depression and anxiety symptoms among adults with moderate to severe depression symptoms at baseline.
This study will examine whether Thrive can also reduce suicidal thinking for persons exhibiting at least moderate depression symptoms. The first phase of the study will implement a randomized waitlist controlled trial. The second phase of the study will examine the effects in a open trial. Outcome assessments will occur at baseline, 4- and 8-weeks (12- and 16-weeks for the waitlist group) with a 6-month follow-up assessment for all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized waitlist controlled trial (first ?? participants) Open trial (following ?? participants)
| Arm | Type | Receives |
|---|---|---|
| Thrive Intervention | Experimental | Behavioral: ThriveOnline cognitive behavior therapy program |
| Waitlist Control | No intervention | –Wait 8 weeks before receiving program access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Montana resident
- 18+ years old
- Have regular access to broadband internet
- PHQ-9 score greater than 4
Key exclusion criteria (4 listed)
- No Montana residency
- < 18 years old
- No broadband internet access
- PHQ-9 score less than 5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThriveAlso: Thrive-MontanaComputerized Cognitive Behavior Therapy program | Behavioural | Thrive Intervention |
Primary outcome
Concise Health Risk Tracking
Time frame: 2 Weeks
Suicidal Thinking; Score range 7 (better) - 35(worse)
4 secondary outcomes
Generalized Anxiety Disorder Scale-7
Time frame: 2 Weeks
Work and Social Adjustment Scale
Time frame: 1 Year
Connor-Davidson Resilience Scale - Abbreviated Version
Time frame: 1 month
Patient Health Questionnaire-9
Time frame: 2 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrive in people with Suicidal Ideation and Depression, run by Montana State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concise Health Risk Tracking (time frame: 2 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.