Depressive SymptomsNCT03244878
Thrive, a Computerized Cognitive Behavior Therapy Program to Treat Depression
A study testing Thrive in people with Depressive Symptoms, run by Montana State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms
- 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
- 464 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 31 Jan 2018
- 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
- Aged 18 years or older
- Baseline PHQ-9 score of 5 or greater
- Montana resident
- Regular access to broadband internet (streaming capability)
Who cannot join
- No broadband internet access
- Aged 17 years or younger
- Does not have Montana residency
- Baseline PHQ-9 score of < 5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of a Culturally-adapted Version of Thrive, a Computerized Cognitive Behavior Therapy (cCBT) Program to Treat Depressive Symptoms, Syndromes, and Disorders Among Rural Montanans
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.
Read the detailed description
Montana ranks high among states on mental health disorder prevalence and low on access to mental health care. It has the highest suicide rate in the nation. Of Montana's 56 counties, 10 are classified as rural and 45 as frontier, accentuating distance challenges in accessing care. New treatment delivery modalities are needed to complement, supplement and augment traditional mental health care. With increase in access to the Internet, computer-administered Cognitive Behavior Therapy (cCBT) programs have emerged as viable approaches to effective treatment of depression.
Thrive is an interactive cCBT program with a heavy emphasis on video rather than text content that appears to improve participant engagement, a shortcoming seen in prior cCBT programs.
The goal of this project is to conduct a randomized wait-list controlled of Thrive to determine its effectiveness in reducing depressive symptom severity among Montanans, many of whom have few or no other options for mental health treatment.
- Conditions
- Depressive Symptoms
- Being tested
- Thrive
- Keywords
- Cognitive Behavior Therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThriveBehavioural
A interactive computerized program using structured content of cognitive behavior therapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Thrive program | Experimental | Participants will receive access to the Thrive program for 8 weeks Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 weeks
Secondary outcomes (3)
Generalized Anxiety Disorder-7
Self-reported measure of anxiety symptoms with a scale from 0 to 3 (not at all to nearly every day)
Measured: 2 weeks
Work and Social Adjustment Scale
Self-reported measure of a chronic condition's impact on daily work and social life with a scale of 0 to 8 (none to very severe)
Measured: 1 year
Connor-Davidson Resilience Scale
Self-reported assessment of personal resilience with a scale of 0 to 3 (not true at all to often true)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start1 May 2017
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies 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
- 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.
- Masking
- None (open label)
- Enrolment
- 464 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark B. Schure, Ph.D., Montana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244878
- Sponsor's protocol ID
- MS033017-FC
- Status last verified
- Aug 2018
- First submitted
- 3 Aug 2017
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33006561Schure 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.
PubMed 31738173
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Culturally-adapted Version of Thrive, a Computerized Cognitive Behavior Therapy (cCBT) Program to Treat Depressive Symptoms, Syndromes, and Disorders Among Rural Montanans
- ClinicalTrials.gov ID
- NCT03244878
- Acronym / sponsor ID
- MS033017-FC
- Conditions
- Depressive Symptoms
- Keywords
- Cognitive Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 464 participants (actual)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 10 Aug 2017 (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 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.
Detailed description
Montana ranks high among states on mental health disorder prevalence and low on access to mental health care. It has the highest suicide rate in the nation. Of Montana's 56 counties, 10 are classified as rural and 45 as frontier, accentuating distance challenges in accessing care. New treatment delivery modalities are needed to complement, supplement and augment traditional mental health care. With increase in access to the Internet, computer-administered Cognitive Behavior Therapy (cCBT) programs have emerged as viable approaches to effective treatment of depression.
Thrive is an interactive cCBT program with a heavy emphasis on video rather than text content that appears to improve participant engagement, a shortcoming seen in prior cCBT programs.
The goal of this project is to conduct a randomized wait-list controlled of Thrive to determine its effectiveness in reducing depressive symptom severity among Montanans, many of whom have few or no other options for mental health treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention - Thrive program | Experimental | Behavioral: ThriveParticipants will receive access to the Thrive program for 8 weeks |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Baseline PHQ-9 score of 5 or greater
- Montana resident
- Regular access to broadband internet (streaming capability)
Key exclusion criteria (4 listed)
- No broadband internet access
- Aged 17 years or younger
- Does not have Montana residency
- Baseline PHQ-9 score of < 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 |
|---|---|---|
| ThriveA interactive computerized program using structured content of cognitive behavior therapy | Behavioural | Intervention - Thrive program |
Primary outcome
Patient Health Questionnaire-9
Time frame: 2 weeks
Clinical measure of depressive symptom severity. Self-reported with a score range from 0 to 3 (not at all to nearly every day)
3 secondary outcomes
Generalized Anxiety Disorder-7
Time frame: 2 weeks
Work and Social Adjustment Scale
Time frame: 1 year
Connor-Davidson Resilience Scale
Time frame: 1 month
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 14 Aug 2018.
- Derived from this study: PubMed 33006561Schure 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.
- Derived from this study: PubMed 31738173Schure 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.
- 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 Depressive Symptoms, 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 14 Aug 2018. 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?
Patient Health Questionnaire-9 (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03244878, which also lists 2 linked publications.
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 14 Aug 2018.