DementiaNCT04696549
Art Museum Program for Seniors With Cognitive Disorders and Care-partners
A study testing Virtual visual art experience guided by Visual Thinking Strategies in people with Dementia, run by Johns Hopkins University at 1 site in United States.
Trial summary
As the population ages, there is increasing interest in developing innovative approaches to promote and sustain mental and emotional well-being. Recent studies have linked engagement with the arts with supporting cognitive functioning, promoting empathy and greater sense of life purpose. Read more about this study
- Who is it for?
- Ages 30 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Virtual visual art experience guided by Visual Thinking Strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2021to 1 Nov 2021
- 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 30 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Club Memory member with cognitive disorder and family care-partner. This will constitute a study dyad.
- Early to moderate cognitive impairment, as evidenced by Clinical Dementia Rating scale of 0.5-2.0. The Clinical Dementia Rating scale is a clinical rating scale used for dementia staging based on 6 domains of functioning that will be performed by Andrea Nelson, Registered Nurse, and is part of normal dementia care in the Johns Hopkins Bayview Memory and Alzheimer's Treatment Center. A rating of 0=normal, 0.5= mild cognitive impairment, 1.0=mild dementia, 2.0=moderate dementia, 3.0=severe dementia.
- Care-partner access to laptop or iPad and comfort with using Zoom technology
- Agreement by individual with cognitive disorder and care-partner to participate in all 3 Visual Thinking visual art sessions
- Agreement by individual with cognitive disorder and care-partner to participate in the study and complete questionnaires before and after each session
Who cannot join
- Non-English speaker
- Clinical Dementia Rating higher than 2.0 for individual with cognitive impairment
- Inability to use a laptop or iPad for Zoom sessions
Trial locations and contacts
1 site in 1 country.
About this study
As the population ages, there is increasing interest in developing innovative approaches to promote and sustain mental and emotional well-being. Recent studies have linked engagement with the arts with supporting cognitive functioning, promoting empathy and greater sense of life purpose. The need to develop alternative approaches to sustain emotional well-being is especially acute for the nearly 6 million older Americans who suffer from Alzheimer's disease. There is a need for quality activities that can be done virtually for homebound individuals with cognitive disorders and the individuals' family care-partners.
The investigators intend to institute a 3-session virtual art museum pilot program for seniors with cognitive disorders and care-partners using the Visual Thinking Strategies approach. The investigators hypothesize that participation in a virtual guided visual arts experience will enhance emotional well-being and self-esteem for both seniors with cognitive impairment and the seniors' care-partners.
Read the detailed description
A number of innovative programs currently exist nationally that are exploring ways to connect to connect older adults with cognitive impairment with the arts. One example is the "Meet Me at MOMA" program at the Museum of Modern Art (MOMA) in New York City, which ran a monthly program for adults with dementia and the adults' care-partners. Researchers studying this program found that participants benefited in terms of improvement in measures of well-being, including higher ratings on scales looking at self-esteem and quality of life . Additionally, other art-based interventions have shown improvements in well-being and mood for the care-partners of individuals with dementia.
One well-validated approach to engaging individuals with works of visual art is "Visual Thinking Strategies". Visual Thinking Strategies (VTS) uses a structured technique to guide viewers to engage with visual art that builds on lived experiences and does not presuppose any knowledge of art or art history. Previous work has utilized Visual Thinking Strategies in educational settings and for clinicians to promote professional identity formation. It has not been studied in clinical settings with patients or with individuals with cognitive disorders. Yet, this approach may have particular benefits for elders with cognitive impairment as it encourages the elders' engagement in the "here and now" and therefore, also provides immediate positive feedback and validation to participants. As such, Visual Thinking Strategies has the potential to contribute to emotional well-being, self-esteem, and meaning for older adults with cognitive impairment.
Subjects: The Johns Hopkins Club Memory Group consists of about 25 older adults with cognitive disorders and the older adults' family care-partners. This group meets twice monthly for social interaction and engagement and is led by senior nurse, Andrea Nelson, Registered Nurse (RN). As this will be a small pilot program, individuals with cognitive disorders and the individuals' care-partners will be individually invited to participate in the program by Andrea Nelson, RN. The investigators intend to recruit a total of 4-6 individuals with early to moderate cognitive impairment and the individuals' care-partners for this pilot program.
Consent process:
Andrea Nelson, Registered Nurse, will obtain telephone consent from both the individuals with cognitive disorder and the individuals' family care-partners. For those individuals who agree to participate, Andrea Nelson, Registered Nurse will screen for eligibility and will do a Clinical Dementia Rating Scale determination by telephone. Participants will receive a written copy of the study by mail.
Study plan:
All study dyads will participate in 3 scheduled Visual Thinking Strategies sessions via Zoom. Each session will last about an hour and will include a guided discussion of pre-selected visual art using the Visual Thinking Strategies approach. It is anticipated that two pieces of art will be shown during each session. The three sessions will be scheduled one month apart. In advance of each session, participants will be mailed the study instruments listed below along with an addressed, stamped envelope to mail the completed forms back to Andrea Nelson, Registered Nurse upon completion.
Immediately prior to the start of each Visual Thinking Strategies art session, both members of the study dyad will be asked to complete the following scales.
- Rosenberg Self-Esteem Scale- This is a 10-item self-report scale with items answered on a 4-point Likert scale from strongly agree to strongly disagree. Although originally developed for adolescents, it is considered to be a valid tool for self-esteem assessment in adults.
- Smiley Face Mood Rating Scale- A pictorial self-report Likert scale with 5 smiley faces ranging from very unhappy to very happy Immediately following each art session, both members of the study dyad will be asked to complete another Smiley Face Mood Rating Scale.
In addition, after each art session, a feedback questionnaire will be completed by the individual with cognitive disorder and a separate feedback questionnaire will be completed by the care-partner. The feedback questionnaires will be completed anytime in the subsequent 2 days following the VTS session. The questionnaires solicit feedback about how enjoyable the art session was and what changes in emotional well-being were experienced as a result of the art session participation.
Participants will return the completed Rosenberg Self-Esteem Scales, Smiley Face Mood Rating Scales, and post-session questionnaires in an addressed, stamped envelope to Andrea Nelson, Registered Nurse.
- Conditions
- Dementia
- Being tested
- Virtual visual art experience guided by Visual Thinking Strategies
- Keywords
- dementia, caregiving, self-esteem
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual visual art experience guided by Visual Thinking StrategiesBehavioural
All study dyads (where study dyad consists of a participant with dementia and his/her care-partner) will participate in 3 scheduled virtual visual art sessions via Zoom. Each session will last about an hour and will include a guided discussion of pre-selected visual art using the Visual Thinking Strategies approach. It is anticipated that two pieces of art will be shown during each art session. The three sessions will be scheduled one month apart.
| Study group | Role | What they receive |
|---|---|---|
| virtual visual art experience for individuals with dementia and their family care-partners | Experimental | Individuals with dementia and their family care-partners will participate in three monthly one-hour virtual art sessions in which the facilitator uses Visual Thinking Strategies technique to facilitate participants' viewing and discussion about virtual art images. Receives: Behavioral: Virtual visual art experience guided by Visual Thinking Strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-esteem as assessed by the Rosenberg Self-Esteem Scale
Impact of participation in a virtual art museum program on both older adults with cognitive disorders and their care-partners on survey measure of self-esteem. The Rosenberg Self-Esteem Scale is a 10-item self-report scale. Each item response is scored on a 4-point Likert Scale where 1 = Strongly agree and 4= Strongly disagree. Higher scores indicate higher self-esteem, and lower scores indicate lower self-esteem.
Measured: At first session and third session, up to 3 months
Change in self-report mood as assessed by the Smiley Face Mood Rating Scale
Impact of participation in a virtual art museum program on both older adults with cognitive disorders and their care-partners on self-report measure of mood. Smiley Face Mood Rating Scale- A pictorial self-report Likert scale with 5 smiley faces ranging from very unhappy (scored as 1), to very happy (scored as 5). Higher scores indicate a more positive mood and lower scores indicate a more negative mood.
Measured: Before and immediately after each visual art session, up to 3 months
Secondary outcomes (6)
to get feedback from family care-partners about their experience in participating in a virtual art museum program regarding satisfaction with a virtual program of this nature
Post-visual art experience questionnaire asking questions about satisfaction. The questionnaire consists of 7 question items, 3 of which are YES/NO response, 2 of which are multiple choice response, one is a 10-point rating scale for satisfaction level where 10 is "very high satisfaction" and 1 is "very low satisfaction". One question is open-narrative free response.
Measured: up to 48 hours after first visual art session
to get feedback from family care-partners about their experience in participating in a virtual art museum program regarding acceptability and satisfaction with a virtual program of this nature
post-visual art experience questionnaire asking questions about satisfaction. The questionnaire consists of 7 question items, 3 of which are YES/NO response, 2 of which are multiple choice response, 1 is a 10-point rating scale for satisfaction level where is "very high satisfaction" and 1 is "very low satisfaction". One question is open-narrative free response
Measured: up to 48 hours after second visual art session
to get feedback from family care-partners about their experience in participating in a virtual art museum program regarding acceptability and satisfaction with a virtual program of this nature
post-visual art experience questionnaire asking questions about satisfaction. The questionnaire consists of 7 question items, 3 of which are YES/NO response, 2 of which are multiple choice response, 1 is a 10-point rating scale for satisfaction level where is "very high satisfaction" and 1 is "very low satisfaction". One question is open-narrative free response
Measured: up to 48 hours after third visual art session
to get feedback from individuals with cognitive disorders about their experience in participating in a virtual art museum program regarding acceptability and satisfaction with a virtual program of this nature
post-visual art experience questionnaire asking questions about satisfaction. The questionnaire consists of 6 question items. 5 items are YES/NO response, and 1 item is multiple choice response
Measured: up to 48 hours after first visual art session
to get feedback from individuals with cognitive disorders about their experience in participating in a virtual art museum program regarding acceptability and satisfaction with a virtual program of this nature
post-visual art experience questionnaire asking questions about satisfaction. The questionnaire consists of 6 question items. 5 items are YES/NO response, and 1 item is multiple choice response
Measured: up to 48 hours after second visual art session
to get feedback from individuals with cognitive disorders about their experience in participating in a virtual art museum program regarding acceptability and satisfaction with a virtual program of this nature
post-visual art experience questionnaire asking questions about satisfaction. The questionnaire consists of 6 question items. 5 items are YES/NO response, and 1 item is multiple choice response
Measured: up to 48 hours after third visual art session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start16 Jul 2021
- Primary completion6 Aug 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan W Lehmann, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696549
- Sponsor's protocol ID
- IRB00267702
- Status last verified
- Nov 2021
- First submitted
- 4 Jan 2021
- Last updated
- 11 Nov 2021
- 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 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Art Museum Program for Seniors With Cognitive Disorders and Care-partners
- ClinicalTrials.gov ID
- NCT04696549
- Acronym / sponsor ID
- IRB00267702
- Conditions
- Dementia
- Keywords
- dementia, caregiving, self-esteem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 6 Aug 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 6 Jan 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.
As the population ages, there is increasing interest in developing innovative approaches to promote and sustain mental and emotional well-being. Recent studies have linked engagement with the arts with supporting cognitive functioning, promoting empathy and greater sense of life purpose. The need to develop alternative approaches to sustain emotional well-being is especially acute for the nearly 6 million older Americans who suffer from Alzheimer's disease. There is a need for quality activities that can be done virtually for homebound individuals with cognitive disorders and the individuals' family care-partners.
The investigators intend to institute a 3-session virtual art museum pilot program for seniors with cognitive disorders and care-partners using the Visual Thinking Strategies approach. The investigators hypothesize that participation in a virtual guided visual arts experience will enhance emotional well-being and self-esteem for both seniors with cognitive impairment and the seniors' care-partners.
Detailed description
A number of innovative programs currently exist nationally that are exploring ways to connect to connect older adults with cognitive impairment with the arts. One example is the "Meet Me at MOMA" program at the Museum of Modern Art (MOMA) in New York City, which ran a monthly program for adults with dementia and the adults' care-partners. Researchers studying this program found that participants benefited in terms of improvement in measures of well-being, including higher ratings on scales looking at self-esteem and quality of life . Additionally, other art-based interventions have shown improvements in well-being and mood for the care-partners of individuals with dementia.
One well-validated approach to engaging individuals with works of visual art is "Visual Thinking Strategies". Visual Thinking Strategies (VTS) uses a structured technique to guide viewers to engage with visual art that builds on lived experiences and does not presuppose any knowledge of art or art history. Previous work has utilized Visual Thinking Strategies in educational settings and for clinicians to promote professional identity formation. It has not been studied in clinical settings with patients or with individuals with cognitive disorders. Yet, this approach may have particular benefits for elders with cognitive impairment as it encourages the elders' engagement in the "here and now" and therefore, also provides immediate positive feedback and validation to participants. As such, Visual Thinking Strategies has the potential to contribute to emotional well-being, self-esteem, and meaning for older adults with cognitive impairment.
Subjects: The Johns Hopkins Club Memory Group consists of about 25 older adults with cognitive disorders and the older adults' family care-partners. This group meets twice monthly for social interaction and engagement and is led by senior nurse, Andrea Nelson, Registered Nurse (RN). As this will be a small pilot program, individuals with cognitive disorders and the individuals' care-partners will be individually invited to participate in the program by Andrea Nelson, RN. The investigators intend to recruit a total of 4-6 individuals with early to moderate cognitive impairment and the individuals' care-partners for this pilot program.
Consent process:
Andrea Nelson, Registered Nurse, will obtain telephone consent from both the individuals with cognitive disorder and the individuals' family care-partners. For those individuals who agree to participate, Andrea Nelson, Registered Nurse will screen for eligibility and will do a Clinical Dementia Rating Scale determination by telephone. Participants will receive a written copy of the study by mail.
Study plan:
All study dyads will participate in 3 scheduled Visual Thinking Strategies sessions via Zoom. Each session will last about an hour and will include a guided discussion of pre-selected visual art using the Visual Thinking Strategies approach. It is anticipated that two pieces of art will be shown during each session. The three sessions will be scheduled one month apart. In advance of each session, participants will be mailed the study instruments listed below along with an addressed, stamped envelope to mail the completed forms back to Andrea Nelson, Registered Nurse upon completion.
Immediately prior to the start of each Visual Thinking Strategies art session, both members of the study dyad will be asked to complete the following scales.
- Rosenberg Self-Esteem Scale- This is a 10-item self-report scale with items answered on a 4-point Likert scale from strongly agree to strongly disagree. Although originally developed for adolescents, it is considered to be a valid tool for self-esteem assessment in adults.
- Smiley Face Mood Rating Scale- A pictorial self-report Likert scale with 5 smiley faces ranging from very unhappy to very happy Immediately following each art session, both members of the study dyad will be asked to complete another Smiley Face Mood Rating Scale.
In addition, after each art session, a feedback questionnaire will be completed by the individual with cognitive disorder and a separate feedback questionnaire will be completed by the care-partner. The feedback questionnaires will be completed anytime in the subsequent 2 days following the VTS session. The questionnaires solicit feedback about how enjoyable the art session was and what changes in emotional well-being were experienced as a result of the art session participation.
Participants will return the completed Rosenberg Self-Esteem Scales, Smiley Face Mood Rating Scales, and post-session questionnaires in an addressed, stamped envelope to Andrea Nelson, Registered Nurse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| virtual visual art experience for individuals with dementia and their family care-partners | Experimental | Behavioral: Virtual visual art experience guided by Visual Thinking StrategiesIndividuals with dementia and their family care-partners will participate in three monthly one-hour virtual art sessions in which the facilitator uses Visual Thinking Strategies technique to facilitate participants' viewing and discussion about virtual art images. |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Club Memory member with cognitive disorder and family care-partner. This will constitute a study dyad.
- Early to moderate cognitive impairment, as evidenced by Clinical Dementia Rating scale of 0.5-2.0. The Clinical Dementia Rating scale is a clinical rating scale used for dementia staging based on 6 domains of functioning that will be performed by Andrea Nelson, Registered Nurse, and is part of normal dementia care in the Johns Hopkins Bayview Memory and Alzheimer's Treatment Center. A rating of 0=normal, 0.5= mild cognitive impairment, 1.0=mild dementia, 2.0=moderate dementia, 3.0=severe dementia.
- Care-partner access to laptop or iPad and comfort with using Zoom technology
- Agreement by individual with cognitive disorder and care-partner to participate in all 3 Visual Thinking visual art sessions
- Agreement by individual with cognitive disorder and care-partner to participate in the study and complete questionnaires before and after each session
Key exclusion criteria (3 listed)
- Non-English speaker
- Clinical Dementia Rating higher than 2.0 for individual with cognitive impairment
- Inability to use a laptop or iPad for Zoom sessions
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 |
|---|---|---|
| Virtual visual art experience guided by Visual Thinking StrategiesAll study dyads (where study dyad consists of a participant with dementia and his/her care-partner) will participate in 3 scheduled virtual visual art sessions via Zoom. Each session will last about an hour and will include a guided discussion of pre-selected visual art using the Visual Thinking Strategies approach. It is anticipated that two pieces of art will be shown during each art session. The three sessions will be scheduled one month apart. | Behavioural | virtual visual art experience for individuals with dementia and their family care-partners |
Primary outcome
Change in self-esteem as assessed by the Rosenberg Self-Esteem Scale
Time frame: At first session and third session, up to 3 months
Impact of participation in a virtual art museum program on both older adults with cognitive disorders and their care-partners on survey measure of self-esteem. The Rosenberg Self-Esteem Scale is a 10-item self-report scale. Each item response is scored on a 4-point Likert Scale where 1 = Strongly agree and 4= Strongly disagree. Higher scores indicate higher self-esteem, and lower scores indicate lower self-esteem.
Change in self-report mood as assessed by the Smiley Face Mood Rating Scale
Time frame: Before and immediately after each visual art session, up to 3 months
Impact of participation in a virtual art museum program on both older adults with cognitive disorders and their care-partners on self-report measure of mood. Smiley Face Mood Rating Scale- A pictorial self-report Likert scale with 5 smiley faces ranging from very unhappy (scored as 1), to very happy (scored as 5). Higher scores indicate a more positive mood and lower scores indicate a more negative mood.
6 secondary outcomes
to get feedback from family care-partners about their experience in participating in a virtual art museum program regarding satisfaction with a virtual program of this nature
Time frame: up to 48 hours after first visual art session
to get feedback from family care-partners about their experience in participating in a virtual art museum program regarding acceptability and satisfaction with a virtual program of this nature
Time frame: up to 48 hours after second visual art session
to get feedback from family care-partners about their experience in participating in a virtual art museum program regarding acceptability and satisfaction with a virtual program of this nature
Time frame: up to 48 hours after third visual art session
to get feedback from individuals with cognitive disorders about their experience in participating in a virtual art museum program regarding acceptability and satisfaction with a virtual program of this nature
Time frame: up to 48 hours after first visual art session
to get feedback from individuals with cognitive disorders about their experience in participating in a virtual art museum program regarding acceptability and satisfaction with a virtual program of this nature
Time frame: up to 48 hours after second visual art session
to get feedback from individuals with cognitive disorders about their experience in participating in a virtual art museum program regarding acceptability and satisfaction with a virtual program of this nature
Time frame: up to 48 hours after third visual art session
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 11 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Dementia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Momentary Coping Prompts and Hair Steroids in College Students
Emotional Regulation, Alcohol Drinking in College
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
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.
Susan W Lehmann, MD principal investigator
Johns Hopkins 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 Virtual visual art experience guided by Visual Thinking Strategies in people with Dementia, run by Johns Hopkins 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 5 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 11 Nov 2021. 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 self-esteem as assessed by the Rosenberg Self-Esteem Scale (time frame: At first session and third session, up to 3 months). 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 11 Nov 2021.