DepressionNCT04961047
Feasibility and Efficacy of a Digital Neurotherapy Protocol for Management of Depression, Cognition, and Quality of Life in Cancer Survivors
A study testing Digital neurotherapy (DNT) Treatment in people with Depression and Cognition, run by Yale University at 1 site in United States.
Trial summary
This is a prospective, randomized clinical study to evaluate the feasibility and efficacy of a digital neurotherapy on depression, cognition, and quality of life in two groups of patients with major medical illness: 1) a sample of cancer survivors, and 2) a sample of patients with end stage kidney disease (ESKD) on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Cognition, Quality of Life
- What is being tested?
- Digital neurotherapy (DNT) Treatment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2021to 31 May 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and date informed consent form.
- Stated willingness to comply with all study procedures and availability for the durationof the study.
- Associated with Smilow Cancer Hospital with a diagnosis for cancer
- Have received chemotherapy, and/or radiation treatment, and/or immuno therapy treatment for cancer
- Able to understand and read English
- Associated with Yale Nephrology practice and receiving in-center hemodialysis treatment
- Have received hemodialysis for at least one month from start of outpatient dialysis and attended 10 of first 12 visits.
Who cannot join
- Stage 4 cancer
- Brain cancer
- Diagnosis of serious mental illness (ie, psychosis)
- Cognitive impairment (ie, diagnosed dementia, intellectual development disorder)
- Hearing or vision insufficient to do the computer exercises.
- ESKD Group
Show all 9Show fewer
- Diagnosis of serious mental illness (ie, psychosis)
- Cognitive Impairment (ie, diagnosed dementia, intellectual development disorder)
- Hearing or vision insufficient to do the computer exercises
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06512
About this study
Official title: Feasibility and Efficacy of a Digital Neurotherapy Protocol for Management of Depression, Cognition, and Quality of Life in Patients With Major Medical Illnesses
This is a prospective, randomized clinical study to evaluate the feasibility and efficacy of a digital neurotherapy on depression, cognition, and quality of life in two groups of patients with major medical illness: 1) a sample of cancer survivors, and 2) a sample of patients with end stage kidney disease (ESKD) on dialysis.
Read the detailed description
This is a randomized, waitlist-control study to evaluate the feasibility and efficacy of an 8-week DNT intervention in patients with major medical illnesses. Waitlisted subjects will be given the option of receiving the DNT after completion of the waitlist period. Subjects will not be blinded to treatment condition.
Hypothesis 1: It is hypothesized that an 8-week DNT intervention will be feasible for 2 groups of patients with major medical illnesses: 1) a group of cancer survivors, and 2) a group of patients with ESKD on dialysis.
Hypothesis 2: It is hypothesized that this intervention will decrease depression symptoms, improve quality of life, and improve attention, executive functioning, and memory.
Study Procedures
General procedure: Potential subjects will be informed of the study and their option to participate by staff and providers during routine clinic visits to the Cancer Survivorship Program at Smilow Cancer Hospital and at routine clinic visits through Yale Nephrology. Interested individuals will be contacted by a member of the research team to assess eligibility. After providing informed consent, subjects will be randomly assigned to either the DNT group or to a waiting-list control group who will then be offered 8 weeks of DNT training at the completion of the final outcome assessment.
Intervention: The experimental group will have 8 weeks of DNT 4 times a week for 30 minutes in the participant's home. The computer-presented training will be done on the participants' tablets or personal computers with the Rejuvenate brain training program. The Rejuvenate program has 7 different games that together train attention, reaction inhibition, cognitive flexibility, use of categories, pattern recognition, memory, dealing with distraction, and auditory and visual perception. In each training session participants do 4 training games for 5 minutes each. Before each 5-minute game, participants are offered three games to choose from. The program keeps track of all the games they choose, and if their training becomes too unbalanced, the games they have been choosing most often are not offered among the three choices until appropriate balance is restored.
Assessment: Assessments will be conducted at 3 intervals (baseline, midpoint, endpoint) for each subject assigned to the experimental group during the 8-week experimental intervention.
- Conditions
- Depression, Cognition, Quality of Life
- Being tested
- Digital neurotherapy (DNT) Treatment, Wait list control group
- Keywords
- Cancer Survivor
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital neurotherapy (DNT) TreatmentBehavioural
The experimental group will have 8 weeks of DNT 4 times a week for 30 minutes in the participant's home. The computer-presented training will be done on the participants' tablets or personal computers with the Rejuvenate brain training program
Wait list control groupBehavioural
Waiting-list control group participants will be offered 8 weeks of DNT training at the completion of the final outcome assessment.
| Study group | Role | What they receive |
|---|---|---|
| Digital neurotherapy (DNT) Treatment | Experimental | The experimental group will have 8 weeks of DNT 4 times a week for 30 minutes in the participant's home. The computer-presented training will be done on the participants' tablets or personal computers with the Rejuvenate brain training program Receives: Behavioral: Digital neurotherapy (DNT) Treatment |
| Wait list control group | Active comparator | Waiting-list control group participants will be offered 8 weeks of DNT training at the completion of the final outcome assessment. Receives: Behavioral: Wait list control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hospital Anxiety and Depression Questionnaire
Hospital Anxiety and Depression Questionnaire (HADS): This survey consists of 14 questions. The questions are related to the frequency of symptoms of anxiety and depression over the last week. Items are rated on a 0-3 scale, with several reverse-scored items. Scores range from 0 to 21. Higher scores indicate more severe symptoms. Administration time is 5 minutes.
Measured: Baseline, 4 weeks, 8 weeks
Change in Patient Health Questionnaire-9
Patient Health Questionnaire-9: (PHQ-9): This survey consists of 9 questions. The questions assess frequency of depression symptoms over the last two weeks. Items are rated on a 0-3 scale. Scores range from 0-27. Higher scores indicate more severe symptoms. Administration time is 5 minutes.
Measured: Baseline, 4 weeks, 8 weeks
Change in Functional Assessment of Cancer Therapy-General
Functional Assessment of Cancer Therapy-General (FACT-G): The FACT-G is a 27-item questionnaire designed to measure four domains of health related quality of life in cancer patients: Physical, social, emotional, and functional well-being. Respondents are asked to answer in reference to the last 7 days. Items are on a 5 point Likert-type scale. Scores range from 0-108 with higher scores indicating higher quality of life. Administration time is 5-10 minutes.
Measured: Baseline, 4 weeks, 8 weeks
Change in Short-Form 36 Health Survey
Functional Assessment of Cancer Therapy-General
Measured: Baseline, 4 weeks, 8 weeks
Change in Mindful Attention Awareness Scale
Mindful Attention Awareness Scale (MAAS): The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. Items are on a 6 point Likert-type scale. Scores range from 15-90, with higher scores indicating higher trait mindfulness. Administration time is 5-10 minutes.
Measured: Baseline, 4 weeks, 8 weeks
Change in Flanker Task
Flanker Task: The Flanker task measures the ability to inhibit nonrelevant competing responses to a nonverbal stimulus. In this task, subjects have to indicate by keyboard response the pointing direction (right or left) of the center arrow in a linear horizontal array of five arrows. On incongruent trials, the four "flanking" arrows point in the opposite direction of the central arrow. There are 29 congruent and 17 incongruent trials presented in pseudorandom order (with 1-4 congruent trials preceding each incongruent trial and one place where there are 2 incongruent in succession). The flanking arrows precede the central arrow by 100m and successive trials are triggered by subject response. Performance is measured by the number of completed trials, accuracy, and reaction times, with higher numbers indicated better overall performance. Administration time is 5 minutes.
Measured: Baseline, 4 weeks, 8 weeks
Change in List Sort Working Memory
List Sort Working Memory: This test is designed to measure working memory. Subjects are shown a series of animals or household objects. They then have to click on the objects they have just seen in a grid of 16 objects in order from smallest to largest rather than the order in which they were presented. The test starts with a list of 2 objects. If the subject completes the list accurately, list length is increased by one. If they err, the same length list is repeated. Two failed attempts at the same list length ends the test. The score is the sum of correct list lengths. In part one, trials of animals and household objects alternate. In part two, animals and household objects are presented in the same trial, and subjects have to reorder the animals first and then the household objects. Administration time is 10 minutes.
Measured: Baseline, 4 weeks, 8 weeks
Change in Logical Memory
Logical Memory: This test is a measure of immediate and delayed auditory memory. In this test, subjects are read two short stories and required to immediately recall details of two short passages. Subjects are then asked to recall the passages after a 20 to 30-minute delay. Initially, the two narrative stories (story A and story B) are verbally given and the examinee is required to immediately recall the stories as much as he/she can. In the delay trial, recall of the two stories is elicited after a 20 to 30-minute delay. Each correct detail was awarded with one score point. The 30 recognition questions (either yes or no) about the two stories are given subsequently to assess the recognition ability. Higher scores indicate better performance. Administration time is approximately 50 minutes including the delay.
Measured: Baseline, 4 weeks, 8 weeks
Change in Multidimensional Executive Function Screening Test
Multidimensional Executive Function Screening Test: This test is a continuous performance task (CPT) with one and two streams and with one-back as well as simple target detection. Targets can be specific abstract visual patterns with systematic degree of differences between targets and foils, and target can be members of a category (e.g., hot things). In one section, there is a concurrent memory task along with the CPT. The test score is "total number of targets clicked minus 25% of the foils clicked." (i.e., total true positive responses minus ¼ of false positive responses). Administration time is 8 minutes.
Measured: Baseline, 4 weeks, 8 weeks
Change in Controlled Oral Word Association Test
Controlled Oral Word Association Test (COWAT): The COWAT is an oral fluency test in which the participant is required to make verbal associations to different letters. The COWAT requires participants to name all the words that they can beginning with specific letters (most commonly F, A, and S) within one minute. The words cannot include proper names and cannot consist of previously used words with a suffix. The total of all correct words is tallied, with higher scores indicating better performance. Administration time is 3 minutes.
Measured: Baseline, 4 weeks, 8 weeks
Change in California Verbal Learning Test-II
California Verbal Learning Test-II (CVLT-II): The CVLT-II is an assessment of verbal learning and memory deficits. The test consists of three lists of words including a recognition list. The first list includes 16 items from four semantic categories; the second list has the same structure, with two semantic categories being the same as in the first list. The recognition list includes 16 target items from the first list, plus distractors that share or do not share semantic or phonological membership with that list. Administration is 30 minutes of testing and 30 minutes of delay.
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start17 Dec 2021
- Primary completion30 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anushree Shirali, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961047
- Sponsor's protocol ID
- 2000031715
- Other IDs
- 2000030524
- Status last verified
- Sep 2025
- First submitted
- 1 Jul 2021
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of a Digital Neurotherapy Protocol for Management of Depression, Cognition, and Quality of Life in Patients With Major Medical Illnesses
- ClinicalTrials.gov ID
- NCT04961047
- Acronym / sponsor ID
- 2000031715
- Conditions
- Depression, Cognition, Quality of Life
- Keywords
- Cancer Survivor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 14 Jul 2021 (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 is a prospective, randomized clinical study to evaluate the feasibility and efficacy of a digital neurotherapy on depression, cognition, and quality of life in two groups of patients with major medical illness: 1) a sample of cancer survivors, and 2) a sample of patients with end stage kidney disease (ESKD) on dialysis.
Detailed description
This is a randomized, waitlist-control study to evaluate the feasibility and efficacy of an 8-week DNT intervention in patients with major medical illnesses. Waitlisted subjects will be given the option of receiving the DNT after completion of the waitlist period. Subjects will not be blinded to treatment condition.
Hypothesis 1: It is hypothesized that an 8-week DNT intervention will be feasible for 2 groups of patients with major medical illnesses: 1) a group of cancer survivors, and 2) a group of patients with ESKD on dialysis.
Hypothesis 2: It is hypothesized that this intervention will decrease depression symptoms, improve quality of life, and improve attention, executive functioning, and memory.
Study Procedures
General procedure: Potential subjects will be informed of the study and their option to participate by staff and providers during routine clinic visits to the Cancer Survivorship Program at Smilow Cancer Hospital and at routine clinic visits through Yale Nephrology. Interested individuals will be contacted by a member of the research team to assess eligibility. After providing informed consent, subjects will be randomly assigned to either the DNT group or to a waiting-list control group who will then be offered 8 weeks of DNT training at the completion of the final outcome assessment.
Intervention: The experimental group will have 8 weeks of DNT 4 times a week for 30 minutes in the participant's home. The computer-presented training will be done on the participants' tablets or personal computers with the Rejuvenate brain training program. The Rejuvenate program has 7 different games that together train attention, reaction inhibition, cognitive flexibility, use of categories, pattern recognition, memory, dealing with distraction, and auditory and visual perception. In each training session participants do 4 training games for 5 minutes each. Before each 5-minute game, participants are offered three games to choose from. The program keeps track of all the games they choose, and if their training becomes too unbalanced, the games they have been choosing most often are not offered among the three choices until appropriate balance is restored.
Assessment: Assessments will be conducted at 3 intervals (baseline, midpoint, endpoint) for each subject assigned to the experimental group during the 8-week experimental intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital neurotherapy (DNT) Treatment | Experimental | Behavioral: Digital neurotherapy (DNT) TreatmentThe experimental group will have 8 weeks of DNT 4 times a week for 30 minutes in the participant's home. The computer-presented training will be done on the participants' tablets or personal computers with the Rejuvenate brain training program |
| Wait list control group | Active comparator | Behavioral: Wait list control groupWaiting-list control group participants will be offered 8 weeks of DNT training at the completion of the final outcome assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of signed and date informed consent form.
- Stated willingness to comply with all study procedures and availability for the durationof the study.
- Associated with Smilow Cancer Hospital with a diagnosis for cancer
- Have received chemotherapy, and/or radiation treatment, and/or immuno therapy treatment for cancer
- Able to understand and read English
Key exclusion criteria (9 listed)
- Stage 4 cancer
- Brain cancer
- Diagnosis of serious mental illness (ie, psychosis)
- Cognitive impairment (ie, diagnosed dementia, intellectual development disorder)
- Hearing or vision insufficient to do the computer exercises.
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 |
|---|---|---|
| Digital neurotherapy (DNT) TreatmentThe experimental group will have 8 weeks of DNT 4 times a week for 30 minutes in the participant's home. The computer-presented training will be done on the participants' tablets or personal computers with the Rejuvenate brain training program | Behavioural | Digital neurotherapy (DNT) Treatment |
| Wait list control groupWaiting-list control group participants will be offered 8 weeks of DNT training at the completion of the final outcome assessment. | Behavioural | Wait list control group |
Primary outcome
Change in Hospital Anxiety and Depression Questionnaire
Time frame: Baseline, 4 weeks, 8 weeks
Hospital Anxiety and Depression Questionnaire (HADS): This survey consists of 14 questions. The questions are related to the frequency of symptoms of anxiety and depression over the last week. Items are rated on a 0-3 scale, with several reverse-scored items. Scores range from 0 to 21. Higher scores indicate more severe symptoms. Administration time is 5 minutes.
Change in Patient Health Questionnaire-9
Time frame: Baseline, 4 weeks, 8 weeks
Patient Health Questionnaire-9: (PHQ-9): This survey consists of 9 questions. The questions assess frequency of depression symptoms over the last two weeks. Items are rated on a 0-3 scale. Scores range from 0-27. Higher scores indicate more severe symptoms. Administration time is 5 minutes.
Change in Functional Assessment of Cancer Therapy-General
Time frame: Baseline, 4 weeks, 8 weeks
Functional Assessment of Cancer Therapy-General (FACT-G): The FACT-G is a 27-item questionnaire designed to measure four domains of health related quality of life in cancer patients: Physical, social, emotional, and functional well-being. Respondents are asked to answer in reference to the last 7 days. Items are on a 5 point Likert-type scale. Scores range from 0-108 with higher scores indicating higher quality of life. Administration time is 5-10 minutes.
Change in Short-Form 36 Health Survey
Time frame: Baseline, 4 weeks, 8 weeks
Functional Assessment of Cancer Therapy-General
Change in Mindful Attention Awareness Scale
Time frame: Baseline, 4 weeks, 8 weeks
Mindful Attention Awareness Scale (MAAS): The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. Items are on a 6 point Likert-type scale. Scores range from 15-90, with higher scores indicating higher trait mindfulness. Administration time is 5-10 minutes.
Change in Flanker Task
Time frame: Baseline, 4 weeks, 8 weeks
Flanker Task: The Flanker task measures the ability to inhibit nonrelevant competing responses to a nonverbal stimulus. In this task, subjects have to indicate by keyboard response the pointing direction (right or left) of the center arrow in a linear horizontal array of five arrows. On incongruent trials, the four "flanking" arrows point in the opposite direction of the central arrow. There are 29 congruent and 17 incongruent trials presented in pseudorandom order (with 1-4 congruent trials preceding each incongruent trial and one place where there are 2 incongruent in succession). The flanking arrows precede the central arrow by 100m and successive trials are triggered by subject response. Performance is measured by the number of completed trials, accuracy, and reaction times, with higher numbers indicated better overall performance. Administration time is 5 minutes.
Change in List Sort Working Memory
Time frame: Baseline, 4 weeks, 8 weeks
List Sort Working Memory: This test is designed to measure working memory. Subjects are shown a series of animals or household objects. They then have to click on the objects they have just seen in a grid of 16 objects in order from smallest to largest rather than the order in which they were presented. The test starts with a list of 2 objects. If the subject completes the list accurately, list length is increased by one. If they err, the same length list is repeated. Two failed attempts at the same list length ends the test. The score is the sum of correct list lengths. In part one, trials of animals and household objects alternate. In part two, animals and household objects are presented in the same trial, and subjects have to reorder the animals first and then the household objects. Administration time is 10 minutes.
Change in Logical Memory
Time frame: Baseline, 4 weeks, 8 weeks
Logical Memory: This test is a measure of immediate and delayed auditory memory. In this test, subjects are read two short stories and required to immediately recall details of two short passages. Subjects are then asked to recall the passages after a 20 to 30-minute delay. Initially, the two narrative stories (story A and story B) are verbally given and the examinee is required to immediately recall the stories as much as he/she can. In the delay trial, recall of the two stories is elicited after a 20 to 30-minute delay. Each correct detail was awarded with one score point. The 30 recognition questions (either yes or no) about the two stories are given subsequently to assess the recognition ability. Higher scores indicate better performance. Administration time is approximately 50 minutes including the delay.
Change in Multidimensional Executive Function Screening Test
Time frame: Baseline, 4 weeks, 8 weeks
Multidimensional Executive Function Screening Test: This test is a continuous performance task (CPT) with one and two streams and with one-back as well as simple target detection. Targets can be specific abstract visual patterns with systematic degree of differences between targets and foils, and target can be members of a category (e.g., hot things). In one section, there is a concurrent memory task along with the CPT. The test score is "total number of targets clicked minus 25% of the foils clicked." (i.e., total true positive responses minus ¼ of false positive responses). Administration time is 8 minutes.
Change in Controlled Oral Word Association Test
Time frame: Baseline, 4 weeks, 8 weeks
Controlled Oral Word Association Test (COWAT): The COWAT is an oral fluency test in which the participant is required to make verbal associations to different letters. The COWAT requires participants to name all the words that they can beginning with specific letters (most commonly F, A, and S) within one minute. The words cannot include proper names and cannot consist of previously used words with a suffix. The total of all correct words is tallied, with higher scores indicating better performance. Administration time is 3 minutes.
Change in California Verbal Learning Test-II
Time frame: Baseline, 4 weeks, 8 weeks
California Verbal Learning Test-II (CVLT-II): The CVLT-II is an assessment of verbal learning and memory deficits. The test consists of three lists of words including a recognition list. The first list includes 16 items from four semantic categories; the second list has the same structure, with two semantic categories being the same as in the first list. The recognition list includes 16 target items from the first list, plus distractors that share or do not share semantic or phonological membership with that list. Administration is 30 minutes of testing and 30 minutes of delay.
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 15 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Anushree Shirali, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital neurotherapy (DNT) Treatment in people with Depression and Cognition, run by Yale 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 7 inclusion and 9 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 15 Sep 2025. 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?
Change in Hospital Anxiety and Depression Questionnaire (time frame: Baseline, 4 weeks, 8 weeks). The study lists 11 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 15 Sep 2025.