Depressive SymptomsNCT01763216
Improving Mood in Assisted Living Settings
A study testing Road Tour and Boatload of Crosswords in people with Depressive Symptoms and Clinical Depression, run by Marianne Smith at 32 sites in United States.
Trial summary
Late-life depression levels are escalating, and include 24% of all tenants of Assisted Living (AL) settings. A promising, novel intervention is a computerized visual speed of processing training program known as Road Tour. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Clinical Depression
- What is being tested?
- Road Tour and Boatload of Crosswords
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 351 participants
- Where
- 32 sitesUnited States
- Study dates
- Feb 2013to 6 Nov 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 55 years old or older
- reside in one of the participating AL settings or affiliated sites
- capable of providing informed consent
Who cannot join
- self-reported insufficient visual acuity (with glasses) to use a computer
- self-reported physical inability to use a computer mouse and keyboard
- non-English speaking
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Lakeview Village Retirement
Amana, Iowa, 52203
The Fountains Senior Community Living
Bettendorf, Iowa, 52722
Carlise Center for Assisted Living
Carlisle, Iowa, 50047
Western Home Communities
Cedar Falls, Iowa, 50613
Irving Point Affordable Assistant Living
Cedar Rapids, Iowa, 52401
Keystone Cedars
Cedar Rapids, Iowa, 52402
Meth-Wick Community
Cedar Rapids, Iowa, 52405
Prairie Hills at Cedar Rapids
Cedar Rapids, Iowa, 52405
Bickford of Clinton
Clinton, Iowa, 52732
Woodlands Creek Active Retirement Community
Clive, Iowa, 50325
Petersen Commons Assisted Living Community of Marycrest
Davenport, Iowa, 52804
Ridgecrest Village
Davenport, Iowa, 52806
Silvercrest Garner Active Retirement Community
Davenport, Iowa, 52806
Senior Star at Elmore Place
Davenport, Iowa, 52807
Wesley Acres
Des Moines, Iowa, 50312
Valley View Village
Des Moines, Iowa, 50317
The Kensington Assisted Living Community
Fort Madison, Iowa, 52627
Legacy Senior Living Community
Iowa City, Iowa, 52240
University of Iowa Colleges of Nursing and Public Health
Iowa City, Iowa, 52242
Emerson Point
Iowa City, Iowa, 52246
Melrose Meadows
Iowa City, Iowa, 52246
Oaknoll Retirement Residence
Iowa City, Iowa, 52246
Bishop Drumm--Martina Place
Johnston, Iowa, 50131
Summit Pointe
Marion, Iowa, 52302
The Villages at Marion
Marion, Iowa, 52302
Iowa Veteran's Home
Marshalltown, Iowa, 50158
Lutheran Living Senior Campus
Muscatine, Iowa, 52761
Manor Health Care Center
Sigourney, Iowa, 52591
Prairie Hills Assisted Living
Tipton, Iowa, 52772
Friendship Village Retirement Community
Waterloo, Iowa, 50702
Simpson Memorial Home, Inc.
West Liberty, Iowa, 52776
Highland Ridge Senior Living Community
Williamsburg, Iowa, 52361
About this study
Official title: Improving Mood in Assisted Living Settings Using a Cognitive Training Intervention
Late-life depression levels are escalating, and include 24% of all tenants of Assisted Living (AL) settings. A promising, novel intervention is a computerized visual speed of processing training program known as Road Tour. Road Tour has been show to reduce depressive symptom levels and the risk of onset of clinical depression in community dwelling older adults. The investigators hypothesize that similar benefits will accrue to residents in AL settings.
To evaluate this the investigators will use a two-arm, parallel, randomized controlled trial (RCT) comparing Road Tour training to attention control using computerized crossword puzzles among 370 adults 55 years old or older who reside in 15-30 AL settings that are partnering with the investigators.
The investigators hypothesize that Road Tour participants will have improved cognitive processing speed, lower levels of depressive symptoms, lower likelihood of the onset of clinical depression, less anxiety, lower levels of pain symptoms, and better health-related quality of life. These outcomes will be assessed at baseline, post-training, six months, and one year.
Read the detailed description
Late-life depression is a large, escalating public health problem that often interacts with other health conditions and leads to spiraling disability that simultaneously threatens independence and health-related quality of life (HRQoL), and increases health care costs. Depression affects 24% of older adults in AL settings, but rates of recognition and treatment are low and underscore the need for alternative depression prevention and treatment methods in AL. A novel and promising intervention is a computerized cognitive training program known as Road Tour, which has shown serendipitous benefits for reducing depression symptoms and the onset of suspected clinical depression consistent with Beck's model of cognitive depression. As a self-directed, user-friendly "game", Road Tour overcomes common attitudinal and resource-related barriers that impede treatment in AL settings, and holds considerable promise for interrupting the potential downward spiral of depression-related disability for 1 million AL elders.
The purpose of this study is to evaluate the effect of Road Tour on processing speed, depressive symptoms and suspected clinical depression, and depression-related comorbidities among AL residents in Iowa. The investigators will use a two-arm, parallel, RCT comparing Road Tour training to attention control using computerized crossword puzzles among 370 adults 55 years old or older. The investigators will actively engage 15-30 AL settings and their associated facilities as study partners who implement the training at their sites and assist with the evaluation process. The investigators will help each AL setting develop AL-specific recruitment and enrollment protocols, educate AL staff about the study, and oversee computerized training by participating residents, as well as their family members and AL staff.
The investigators' three specific aims are to: (1) establish the effect of Road Tour on improving cognitive processing speed in AL; (2) evaluate the effect of Road Tour on reducing depressive symptoms and the risk of onset of suspected clinical depression in AL; and, (3) evaluate the effect of Road Tour on the depression-related health outcomes of anxiety, pain, and HRQoL in AL.
Participants will receive 10 hours of computerized training over 5-6 weeks, and 4 hours of booster training at months 5 and 11, for a total of 18 hours of training. Outcomes are changes in the Useful Field of View (UFOV) test for speed of processing (Aim 1), changes in the 12-item Centers for Epidemiologic Studies Depression scale (CESD-12) and the 9-item Patient Health Questionnaire (PHQ-9) for depressive symptoms and suspected clinical depression (Aim 2), and changes in the Short Form 36-item Health-Related Quality of Life (HRQoL) Questionnaire (SF-36) for HRQoL, the Brief Pain Inventory (BPI) for pain, and 7-item Generalized Anxiety Disorder questionnaire (GAD-7) for anxiety (Aim 3). Data will be collected using telephone interviews at baseline, post-training (6-8 weeks), and at 26-weeks and 52-weeks. Linear mixed effect models that adjust for the clustering within AL settings will be used with main effects specified for treatment group and time, as well as their two-way interaction. This study is the first step in evaluating depression-related outcomes of using Road Tour in AL settings.
- Conditions
- Depressive Symptoms, Clinical Depression
- Being tested
- Road Tour, Boatload of Crosswords
- Keywords
- depressive symptoms, clinical depression, visual processing speed, anxiety, pain, health-related quality of life
- Medical subject headings
- Depression, Depressive Disorder, Major, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Road TourOther
Also called Road Tour at http://www.positscience.com
Training dosage includes 10 hours at baseline, four hours of booster training at month five, and four hours of booster training at month 11.
Boatload of CrosswordsOther
Also called Boatload of Crosswords at http://www./boatloadpuzzles.com
Training dosage includes 10 hours at baseline, four hours of booster training at month five, and four hours of booster training at month 11.
| Study group | Role | What they receive |
|---|---|---|
| Road Tour | Experimental | Road Tour was designed to improve the efficiency and accuracy of visual information processing and the ability to perform complex visual attention tasks. It focuses on improving the speed and accuracy with which users identify and locate visual information using a divided attention format. Over time, the difficulty and complexity of each task is systematically increased as users attain specified performance criteria. Difficulty is increased by reducing visual stimuli duration, adding visual distracters, increasing similarity between target and distracter stimuli, and presenting visual targets over a broader spatial expanse. Receives: Other: Road Tour |
| Boatload of Crosswords | Sham comparator | Boatload of Crosswords offers the user a choice between three puzzle sizes, three levels of complexity, and varying font sizes. It also provides optional help features that the user may select, like filling in a letter or word to minimize frustration levels often associated with puzzle completion. Boatload of Crosswords was chosen for this study because it is computerized, it is very popular and easy to use, and many older adults enjoy doing crossword puzzles. Boatload of Crosswords, however, does not improve speed of processing because it does not focus on central discrimination and peripheral target location. Indeed, Boatload of Crosswords is not designed to train on any aspect of cognitive ability associated with visual speed of processing. Receives: Other: Boatload of Crosswords |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Patient Health Questionnaire (PHQ-9)
The PHQ-9 items reflect the nine Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnostic criteria for major depression and are rated from 0=not at all to 3=nearly every day for a total score range of 0-27. Established cut-points are: 0-4= minimal depression; 5-9=mild depression; 10-14=moderate depression; 15 or greater = severe depression. Scores of 10 or more indicate suspected clinically significant depression. The PHQ-9 facilitates direct assessment of two hallmarks of major depression (prominent dysphoria and anhedonia) and comparison to another body of late life depression research.
Measured: baseline, post-training, six months, one year
Changes in the Centers for Epidemiological Studies Depression (CESD) 12-item scale
A shorter version of the original CESD-20 that has been a gold standard for screening for depression in epidemiological, field, and public survey studies, and has very high reliability and validity. Because the CESD-12 was used in the Iowa Healthy and Active Minds Study (IHAMS) and the Advanced Cognitive Training for Independent Vital Elderly (ACTIVE) study, direct comparison of depression outcomes among AL participants in this study and community-dwelling subjects in those studies can occur. CESD-12 is composed of short statements scored from 0=rarely or none of time (less than 1 day per week) to 3=all of the time (5-7 days per week) for a score range of 0-36. The cut-off score for suspected clinical depression on the CESD-12 is 9 or more points, which is equivalent to 16 or more points for the CESD-20.
Measured: baseline, post-training, six months, one year
Secondary outcomes (5)
Changes in the Useful Field of View (UFOV)
The UFOV is well-established, has high reliability and validity, and is the gold standard for measuring visual processing speed. UFOV includes three subtests-stimulus identification, divided attention, and selective attention-each automatically scored from 17-500 ms reflecting the shortest exposure time at which the participant could correctly perform each subtest 75% of the time, with a composite ms outcome score ranging from 51-1500 ms. Scores represent the shortest display duration with which the respondent performs accurately on 75% of the trials.
Measured: baseline, post-training, six months, one year
Changes in the Short Form 36 Item Health-Related Quality of Life (SF-36) Scale
The SF-36 is the most widely used measure of health-related quality of life, and consists of 36 items that make up eight subscales. Its reliability and validity are well established in the US and elsewhere. Subscale scores range from 0 for worst health to 100 for best health.
Measured: baseline, and one year
Changes in the Short Form 12 Item Health-Related Quality of Life (SF-12)
The SF-12 is an abbreviated version of the SF-36 health-related quality of life measure, and consists of 12 items that make up eight subscales. Its reliability and validity are well established in the US and elsewhere. Subscale scores range from 0 for worst health to 100 for best health. It is used here at post-training and six months to minimize respondent fatigue.
Measured: post-training and six months
Changes in the Brief Pain Invention (BPI)
The Brief Pain Inventory (BPI) multi-item severity and interference scales have been adopted for telephone use. It consists of likert scaled and thermometer response options. We will examine mean changes in both scales over time, as well as declines in pain scores > 30%, which are considered clinically meaningful.
Measured: baseline, post-training, six months, one year
Changes in the Generalized Anxiety Disorder (GAD-7) Questionnaire
The highly reliable and valid 7-item Generalized Anxiety Disorder (GAD-7) scale rates the DSM-IV criteria for GAD with a response set ranging from 0=not at all to 3=nearly every day. Cut-points for the GAD-7 are comparable to the PHQ-9, with 0-4= minimal anxiety; 5-9=mild anxiety; and 10 or more=clinically significant anxiety.
Measured: baseline, post-training, six months, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2016
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marianne Smith
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marianne Smith, University of Iowa
- Investigators
- Marianne Smith, Ph.D., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763216
- Sponsor's protocol ID
- 201208786
- Status last verified
- Nov 2020
- First submitted
- 3 Jan 2013
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mood in Assisted Living Settings Using a Cognitive Training Intervention
- ClinicalTrials.gov ID
- NCT01763216
- Acronym / sponsor ID
- 201208786
- Conditions
- Depressive Symptoms, Clinical Depression
- Keywords
- depressive symptoms, clinical depression, visual processing speed, anxiety, pain, health-related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Marianne SmithUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 8 Jan 2013 (estimated)
- 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.
Late-life depression levels are escalating, and include 24% of all tenants of Assisted Living (AL) settings. A promising, novel intervention is a computerized visual speed of processing training program known as Road Tour. Road Tour has been show to reduce depressive symptom levels and the risk of onset of clinical depression in community dwelling older adults. The investigators hypothesize that similar benefits will accrue to residents in AL settings.
To evaluate this the investigators will use a two-arm, parallel, randomized controlled trial (RCT) comparing Road Tour training to attention control using computerized crossword puzzles among 370 adults 55 years old or older who reside in 15-30 AL settings that are partnering with the investigators.
The investigators hypothesize that Road Tour participants will have improved cognitive processing speed, lower levels of depressive symptoms, lower likelihood of the onset of clinical depression, less anxiety, lower levels of pain symptoms, and better health-related quality of life. These outcomes will be assessed at baseline, post-training, six months, and one year.
Detailed description
Late-life depression is a large, escalating public health problem that often interacts with other health conditions and leads to spiraling disability that simultaneously threatens independence and health-related quality of life (HRQoL), and increases health care costs. Depression affects 24% of older adults in AL settings, but rates of recognition and treatment are low and underscore the need for alternative depression prevention and treatment methods in AL. A novel and promising intervention is a computerized cognitive training program known as Road Tour, which has shown serendipitous benefits for reducing depression symptoms and the onset of suspected clinical depression consistent with Beck's model of cognitive depression. As a self-directed, user-friendly "game", Road Tour overcomes common attitudinal and resource-related barriers that impede treatment in AL settings, and holds considerable promise for interrupting the potential downward spiral of depression-related disability for 1 million AL elders.
The purpose of this study is to evaluate the effect of Road Tour on processing speed, depressive symptoms and suspected clinical depression, and depression-related comorbidities among AL residents in Iowa. The investigators will use a two-arm, parallel, RCT comparing Road Tour training to attention control using computerized crossword puzzles among 370 adults 55 years old or older. The investigators will actively engage 15-30 AL settings and their associated facilities as study partners who implement the training at their sites and assist with the evaluation process. The investigators will help each AL setting develop AL-specific recruitment and enrollment protocols, educate AL staff about the study, and oversee computerized training by participating residents, as well as their family members and AL staff.
The investigators' three specific aims are to: (1) establish the effect of Road Tour on improving cognitive processing speed in AL; (2) evaluate the effect of Road Tour on reducing depressive symptoms and the risk of onset of suspected clinical depression in AL; and, (3) evaluate the effect of Road Tour on the depression-related health outcomes of anxiety, pain, and HRQoL in AL.
Participants will receive 10 hours of computerized training over 5-6 weeks, and 4 hours of booster training at months 5 and 11, for a total of 18 hours of training. Outcomes are changes in the Useful Field of View (UFOV) test for speed of processing (Aim 1), changes in the 12-item Centers for Epidemiologic Studies Depression scale (CESD-12) and the 9-item Patient Health Questionnaire (PHQ-9) for depressive symptoms and suspected clinical depression (Aim 2), and changes in the Short Form 36-item Health-Related Quality of Life (HRQoL) Questionnaire (SF-36) for HRQoL, the Brief Pain Inventory (BPI) for pain, and 7-item Generalized Anxiety Disorder questionnaire (GAD-7) for anxiety (Aim 3). Data will be collected using telephone interviews at baseline, post-training (6-8 weeks), and at 26-weeks and 52-weeks. Linear mixed effect models that adjust for the clustering within AL settings will be used with main effects specified for treatment group and time, as well as their two-way interaction. This study is the first step in evaluating depression-related outcomes of using Road Tour in AL settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Road Tour | Experimental | Other: Road TourRoad Tour was designed to improve the efficiency and accuracy of visual information processing and the ability to perform complex visual attention tasks. It focuses on improving the speed and accuracy with which users identify and locate visual information using a divided attention format. Over time, the difficulty and complexity of each task is systematically increased as users attain specified performance criteria. Difficulty is increased by reducing visual stimuli duration, adding visual distracters, increasing similarity between target and distracter stimuli, and presenting visual targets over a broader spatial expanse. |
| Boatload of Crosswords | Sham comparator | Other: Boatload of CrosswordsBoatload of Crosswords offers the user a choice between three puzzle sizes, three levels of complexity, and varying font sizes. It also provides optional help features that the user may select, like filling in a letter or word to minimize frustration levels often associated with puzzle completion. Boatload of Crosswords was chosen for this study because it is computerized, it is very popular and easy to use, and many older adults enjoy doing crossword puzzles. Boatload of Crosswords, however, does not improve speed of processing because it does not focus on central discrimination and peripheral target location. Indeed, Boatload of Crosswords is not designed to train on any aspect of cognitive ability associated with visual speed of processing. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 55 years old or older
- reside in one of the participating AL settings or affiliated sites
- capable of providing informed consent
Key exclusion criteria (3 listed)
- self-reported insufficient visual acuity (with glasses) to use a computer
- self-reported physical inability to use a computer mouse and keyboard
- non-English speaking
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 |
|---|---|---|
| Road TourAlso: Road Tour at http://www.positscience.comTraining dosage includes 10 hours at baseline, four hours of booster training at month five, and four hours of booster training at month 11. | Other | Road Tour |
| Boatload of CrosswordsAlso: Boatload of Crosswords at http://www./boatloadpuzzles.comTraining dosage includes 10 hours at baseline, four hours of booster training at month five, and four hours of booster training at month 11. | Other | Boatload of Crosswords |
Primary outcome
Changes in the Patient Health Questionnaire (PHQ-9)
Time frame: baseline, post-training, six months, one year
The PHQ-9 items reflect the nine Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnostic criteria for major depression and are rated from 0=not at all to 3=nearly every day for a total score range of 0-27. Established cut-points are: 0-4= minimal depression; 5-9=mild depression; 10-14=moderate depression; 15 or greater = severe depression. Scores of 10 or more indicate suspected clinically significant depression. The PHQ-9 facilitates direct assessment of two hallmarks of major depression (prominent dysphoria and anhedonia) and comparison to another body of late life depression research.
Changes in the Centers for Epidemiological Studies Depression (CESD) 12-item scale
Time frame: baseline, post-training, six months, one year
A shorter version of the original CESD-20 that has been a gold standard for screening for depression in epidemiological, field, and public survey studies, and has very high reliability and validity. Because the CESD-12 was used in the Iowa Healthy and Active Minds Study (IHAMS) and the Advanced Cognitive Training for Independent Vital Elderly (ACTIVE) study, direct comparison of depression outcomes among AL participants in this study and community-dwelling subjects in those studies can occur. CESD-12 is composed of short statements scored from 0=rarely or none of time (less than 1 day per week) to 3=all of the time (5-7 days per week) for a score range of 0-36. The cut-off score for suspected clinical depression on the CESD-12 is 9 or more points, which is equivalent to 16 or more points for the CESD-20.
5 secondary outcomes
Changes in the Useful Field of View (UFOV)
Time frame: baseline, post-training, six months, one year
Changes in the Short Form 36 Item Health-Related Quality of Life (SF-36) Scale
Time frame: baseline, and one year
Changes in the Short Form 12 Item Health-Related Quality of Life (SF-12)
Time frame: post-training and six months
Changes in the Brief Pain Invention (BPI)
Time frame: baseline, post-training, six months, one year
Changes in the Generalized Anxiety Disorder (GAD-7) Questionnaire
Time frame: baseline, post-training, six months, one year
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 9 Nov 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.
Marianne Smith, Ph.D. principal investigator
University of Iowa
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Road Tour and Boatload of Crosswords in people with Depressive Symptoms and Clinical Depression, run by Marianne Smith at 32 sites 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 3 inclusion and 3 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 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites 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. Some participants in this study may receive a placebo. 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?
Changes in the Patient Health Questionnaire (PHQ-9) (time frame: baseline, post-training, six months, one year). The study lists 2 primary outcomes in all. 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 9 Nov 2020.