ObesityHEARTSNCT05561595
Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma
A study testing Healing HEARTS and Peer Support in people with Obesity and Skin Disease, run by University of Florida at 1 site in United States.
Trial summary
Stigma due to health conditions increases disease burden and adversely impacts health. The internalization of health-related stigma is associated with impaired mental health and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Skin Disease, Cancer
- What is being tested?
- Healing HEARTS and Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 years or older
- Currently residing in the United States
- At least one of the following stigmatized health conditions:
- Obesity (or high body weight that negatively affects health)
- Skin disease (including but not limited to psoriasis, eczema, or vitiligo)
- Cancer (including but not limited to lung, breast, cervical, colorectal, gynecologic, prostate, or head and neck; including individuals in remission)
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- HIV
- Type 1 or type 2 diabetes
- Chronic pain
- Reported internalization of health-related stigma, as determined by a pre-specified cutoff score on internalized stigma measure and confirmed by interview
- Participants must have availability to attend weekly virtual group meetings for 12 weeks, followed by every-other-week and monthly meetings through 26 weeks, in the evening on a specified weekday. Participants must be willing to actively participate and share information about themselves in the group meetings.
- Participants must be able to read, comprehend, and speak English in order to participate in group sessions and complete study questionnaires.
- Participation requires an electronic device (computer, tablet, or phone) with video capabilities and internet, wi-fi, or cellular data in order to attend group sessions and complete study questionnaires. Individuals who do not have such devices or internet access will still be eligible to participate. In such cases, screening procedures will be conducted by phone, and randomized participants will be provided with web cameras or internet-enabled devices (and/or provided with pre-paid cellular data) to facilitate participation.
Who cannot join
- Current or recent (e.g., past 3 months) receipt of psychotherapy or a psychosocial or peer support intervention (exceptions may be made if therapy or support is not focused on health conditions and is unlikely to affect internalized health-related stigma; e.g., family or marriage counseling, religious study groups, etc.)
- Psychiatric hospitalization in the past 6 months
- Recent (e.g., past 3 months, approximately) change in medications taken for psychiatric reasons
- Current, active suicidal thoughts or suicide attempt within the past year
- Current or past thought disorder or psychosis, or unmanaged bipolar disorder
- Current alcohol/substance use disorder that requires immediate treatment
Show all 10Show fewer
- Health-related stigma due primarily to mental illness or substance use, or due to health conditions not specified in inclusion criteria.
- No reported internalization of health-related stigma and/or score below pre-specified cutoff on internalized stigma measure
- Unwilling or unable to complete study procedures
- Participants with severe progression of disease (e.g., end-of-life) or who are undergoing acute, intensive treatment (such as chemotherapy or radiation therapy) will not be eligible to participate due to expected impacts on HRQOL and greater needs for psychological support than the intervention is intended to provide. Such participants may be eligible after completion of acute treatment or if severe symptoms remit and/or prognosis improves.
Trial locations and contacts
1 site in 1 country.
About this study
Stigma due to health conditions increases disease burden and adversely impacts health. The internalization of health-related stigma is associated with impaired mental health and quality of life. The current project will test the effects of a novel, transdiagnostic, group counseling intervention, and peer support, to determine the optimal method for helping patients cope with health-related stigma, reducing its internalization, and enhancing patient quality of life.
Read the detailed description
This randomized controlled trial (RCT) will test in a sample of 195 patients with high levels of internalized health-related stigma the effects of a novel transdiagnostic intervention designed to help patients cope with this stigma and to reduce its internalization. Participants will be randomly assigned to one of three intervention conditions: (1) a group-based counseling intervention designed to target internalized health-related stigma, delivered virtually (i.e., via telehealth); (2) a general peer support group conducted via telehealth without a targeted stigma intervention; or (3) a waitlist control group. The counseling and peer support conditions will provide 12 weekly group sessions, followed by 2 every other week sessions and 2 monthly sessions (16 sessions total over the course of 26 weeks, or 6 months). Participants across all conditions will complete outcome assessment visits at baseline/randomization, week 12, and week 26. The waitlist control group will receive 12 weeks of the group counseling intervention (condition #1) after completing the week 26 assessment. The primary trial outcome will be the change in internalized stigma from baseline to week 12 (following the most intensive part of the intervention). Change in internalized stigma from baseline to week 26 will be a secondary outcome to determine lasting effects of the intervention in a "maintenance" period with less frequent intervention. Other secondary outcomes will include depression, anxiety, stress, coping, and health-related quality of life (HRQOL)
- Conditions
- Obesity, Skin Disease, Cancer, HIV, Diabetes, Chronic Pain
- Being tested
- Healing HEARTS, Peer Support
- Medical subject headings
- Obesity, Skin Diseases, Neoplasms, Diabetes Mellitus, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healing HEARTSBehavioural
Session topics will include: psychoeducation; myths and stereotypes; cognitive distortions and restructuring; coping strategies; interpersonal effectiveness; self-efficacy; mindfulness and self-compassion; acceptance and positive self-image; disclosure and finding support; stigma in health care; and empowerment and advocacy.
Peer SupportBehavioural
Peer support groups will cover general topics such as symptom management, stress, and social support. Stigma will not be a formal topic of discussion, and group leaders will be trained to avoid initiating conversations about stigma; however, to capture realistic discussions in peer support groups, participants will not be prohibited from discussing the topic should they bring it up.
| Study group | Role | What they receive |
|---|---|---|
| Healing HEARTS Intervention | Experimental | The Healing Health-Related Stigma (Healing HEARTS) intervention will provide group telehealth sessions adapted from prior disease-specific interventions for internalized stigma and from standard techniques and structures used in evidence-based cognitive-behavioral therapies. Fifty-minute sessions will be delivered weekly for 12 weeks, followed by 2 every-other-week and 2 monthly sessions. Groups will consist of approximately 8-10 participants and will be led by a doctoral- or masters-level clinician in clinical or counseling psychology or social work. Handouts and homework assignments will be used as part of the group meetings. All group sessions will be conducted remotely using telehealth technology. Receives: Behavioral: Healing HEARTS |
| Peer Support | Active comparator | The peer support condition will provide group telehealth sessions without any tailored stigma content. Group sessions will be 50 minutes and will meet weekly for 12 weeks, followed by 2 every-other-week and 2 monthly sessions. Groups will consist of approximately 8-10 participants and will be led by a doctoral- or masters-level clinician in clinical or counseling psychology or social work. All group sessions will be conducted remotely using telehealth technology. Receives: Behavioral: Peer Support |
| Waitlist Control | No intervention | The waitlist control group will not receive any active intervention until after completing week 12 and week 26 assessments. Participants will receive periodical updates and reminders from study staff to enhance retention. After assessments are completed, participants will be provided with 12 weeks of the Healing HEARTS intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Internalized Health-Related Stigma Scale score at Week 12
Estimated mean change score for the total scale (primary outcome) and three subscales (Perceived and Anticipated Stigma, Stereotype Application and Self-Devaluation, and Stigma Resistance); scale scores are averaged and range from 1-7, with higher scores indicating greater internalized health-related stigma.
Measured: Baseline to Week 12
Secondary outcomes (21)
Change in Internalized Health-Related Stigma Scale score at Week 26
Estimated mean change score for the total scale (primary outcome) and three subscales (Perceived and Anticipated Stigma, Stereotype Application and Self-Devaluation, and Stigma Resistance); scale scores are averaged and range from 1-7, with higher scores indicating greater internalized health-related stigma.
Measured: Baseline to Week 26
Change in Internalized Shame Scale score at Week 12
Estimated mean change score for two subscales: Shame (summed scores range from 0-96, higher scores indicate greater shame) and Self-Esteem (summed scores range from 0-24, higher scores indicate higher self-esteem).
Measured: Baseline to Week 12
Change in Internalized Shame Scale score at Week 26
Estimated mean change score for two subscales: Shame (summed scores range from 0-96, higher scores indicate greater shame) and Self-Esteem (summed scores range from 0-24, higher scores indicate higher self-esteem).
Measured: Baseline to Week 26
Change in UCLA Loneliness Scale score at Week 12
Estimated mean change score, with summed scores ranging from 20-80 (higher scores indicate greater loneliness/isolation).
Measured: Baseline to Week 12
Change in UCLA Loneliness Scale score at Week 26
Estimated mean change score, with summed scores ranging from 20-80 (higher scores indicate greater loneliness/isolation).
Measured: Baseline to Week 26
Change in Patient Health Questionnaire-9 score at Week 12
Estimated mean change score, with summed scores ranging from 0-27 (higher scores indicate greater severity of depression symptoms).
Measured: Baseline to Week 12
Change in Patient Health Questionnaire-9 score at Week 26
Estimated mean change score, with summed scores ranging from 0-27 (higher scores indicate greater severity of depression symptoms).
Measured: Baseline to Week 26
Change in Generalized Anxiety Disorder-7 Questionnaire score at Week 12
Estimated mean change score, with summed scores ranging from 0-21 (higher scores indicate greater severity of generalized anxiety).
Measured: Baseline to Week 12
Change in Generalized Anxiety Disorder-7 Questionnaire score at Week 26
Estimated mean change score, with summed scores ranging from 0-21 (higher scores indicate greater severity of generalized anxiety).
Measured: Baseline to Week 26
Change in Severity Measure for Social Anxiety Disorder score at Week 12
Estimated mean change score, with summed scores ranging from 0-40 (higher scores indicate greater severity of social anxiety).
Measured: Baseline to Week 12
Change in Severity Measure for Social Anxiety Disorder score at Week 26
Estimated mean change score, with summed scores ranging from 0-40 (higher scores indicate greater severity of social anxiety).
Measured: Baseline to Week 26
Change in 4-item Perceived Stress Scale score at Week 12
Estimated mean change score, with summed scores ranging from 0-16 (higher scores indicate greater perceived stress).
Measured: Baseline to Week 12
Change in 4-item Perceived Stress Scale score at Week 26
Estimated mean change score, with summed scores ranging from 0-16 (higher scores indicate greater perceived stress).
Measured: Baseline to Week 26
Change in General Self-Efficacy Scale score at Week 12
Estimated mean change score, with summed scores ranging from 10-40 (higher scores indicate greater self-efficacy).
Measured: Baseline to Week 12
Change in General Self-Efficacy Scale score at Week 26
Estimated mean change score, with summed scores ranging from 10-40 (higher scores indicate greater self-efficacy).
Measured: Baseline to Week 26
Change in Revised Illness Perceptions Questionnaire scores at Week 12
Estimated mean change scores on four subscales: Consequences, Personal Control, Illness Coherence, and Emotional Representations. Scores for each subscale are averaged, with ratings ranging from 1-5, and higher scores Indicating greater perceived consequences, control, understanding, and emotional impacts of health conditions, respectively.
Measured: Baseline to Week 12
Change in Revised Illness Perceptions Questionnaire scores at Week 26
Estimated mean change scores on four subscales: Consequences, Personal Control, Illness Coherence, and Emotional Representations. Scores for each subscale are averaged, with ratings ranging from 1-5, and higher scores Indicating greater perceived consequences, control, understanding, and emotional impacts of health conditions, respectively.
Measured: Baseline to Week 26
Change in SF-12v2 scores at Week 12
Estimated mean change scores in mental and physical health component t-scores, with a population mean score of 50 and standard deviation of 10 (higher scores indicate better mental and physical health-related quality of life, respectively).
Measured: Baseline to Week 12
Change in SF-12v2 scores at Week 26
Estimated mean change scores in mental and physical health component t-scores, with a population mean score of 50 and standard deviation of 10 (higher scores indicate better mental and physical health-related quality of life, respectively).
Measured: Baseline to Week 26
Change in CDC Healthy Days Core Measure at Week 12
Estimated mean change scores in items assessing the number of unhealthy days due to physical and mental health, respectively (range 0-30 days), the number of days of impairment due to poor health (0-30 days), and an unhealthy days index score of total combined physically and mentally unhealthy days (0-30 days).
Measured: Baseline to Week 12
Change in CDC Healthy Days Core Measure at Week 26
Estimated mean change scores in items assessing the number of unhealthy days due to physical and mental health, respectively (range 0-30 days), the number of days of impairment due to poor health (0-30 days), and an unhealthy days index score of total combined physically and mentally unhealthy days (0-30 days).
Measured: Baseline to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start3 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Rebecca Pearl, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561595
- Sponsor's protocol ID
- IRB202201862
- Other IDs
- DP2MH132938, PRO00041153
- Acronym
- HEARTS
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2022
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared via the National Institute of Mental Health (NIMH) Data Archive (NDA; https://nda.nih.gov).
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma
- ClinicalTrials.gov ID
- NCT05561595
- Acronym / sponsor ID
- HEARTS / IRB202201862
- Conditions
- Obesity, Skin Disease, Cancer, HIV, Diabetes, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institutes of Health (NIH)
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Sep 2022 (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.
Stigma due to health conditions increases disease burden and adversely impacts health. The internalization of health-related stigma is associated with impaired mental health and quality of life. The current project will test the effects of a novel, transdiagnostic, group counseling intervention, and peer support, to determine the optimal method for helping patients cope with health-related stigma, reducing its internalization, and enhancing patient quality of life.
Detailed description
This randomized controlled trial (RCT) will test in a sample of 195 patients with high levels of internalized health-related stigma the effects of a novel transdiagnostic intervention designed to help patients cope with this stigma and to reduce its internalization. Participants will be randomly assigned to one of three intervention conditions: (1) a group-based counseling intervention designed to target internalized health-related stigma, delivered virtually (i.e., via telehealth); (2) a general peer support group conducted via telehealth without a targeted stigma intervention; or (3) a waitlist control group. The counseling and peer support conditions will provide 12 weekly group sessions, followed by 2 every other week sessions and 2 monthly sessions (16 sessions total over the course of 26 weeks, or 6 months). Participants across all conditions will complete outcome assessment visits at baseline/randomization, week 12, and week 26. The waitlist control group will receive 12 weeks of the group counseling intervention (condition #1) after completing the week 26 assessment. The primary trial outcome will be the change in internalized stigma from baseline to week 12 (following the most intensive part of the intervention). Change in internalized stigma from baseline to week 26 will be a secondary outcome to determine lasting effects of the intervention in a "maintenance" period with less frequent intervention. Other secondary outcomes will include depression, anxiety, stress, coping, and health-related quality of life (HRQOL)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healing HEARTS Intervention | Experimental | Behavioral: Healing HEARTSThe Healing Health-Related Stigma (Healing HEARTS) intervention will provide group telehealth sessions adapted from prior disease-specific interventions for internalized stigma and from standard techniques and structures used in evidence-based cognitive-behavioral therapies. Fifty-minute sessions will be delivered weekly for 12 weeks, followed by 2 every-other-week and 2 monthly sessions. Groups will consist of approximately 8-10 participants and will be led by a doctoral- or masters-level clinician in clinical or counseling psychology or social work. Handouts and homework assignments will be used as part of the group meetings. All group sessions will be conducted remotely using telehealth technology. |
| Peer Support | Active comparator | Behavioral: Peer SupportThe peer support condition will provide group telehealth sessions without any tailored stigma content. Group sessions will be 50 minutes and will meet weekly for 12 weeks, followed by 2 every-other-week and 2 monthly sessions. Groups will consist of approximately 8-10 participants and will be led by a doctoral- or masters-level clinician in clinical or counseling psychology or social work. All group sessions will be conducted remotely using telehealth technology. |
| Waitlist Control | No intervention | –The waitlist control group will not receive any active intervention until after completing week 12 and week 26 assessments. Participants will receive periodical updates and reminders from study staff to enhance retention. After assessments are completed, participants will be provided with 12 weeks of the Healing HEARTS intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18 years or older
- Currently residing in the United States
- At least one of the following stigmatized health conditions:
- Obesity (or high body weight that negatively affects health)
- Skin disease (including but not limited to psoriasis, eczema, or vitiligo)
Key exclusion criteria (10 listed)
- Current or recent (e.g., past 3 months) receipt of psychotherapy or a psychosocial or peer support intervention (exceptions may be made if therapy or support is not focused on health conditions and is unlikely to affect internalized health-related stigma; e.g., family or marriage counseling, religious study groups, etc.)
- Psychiatric hospitalization in the past 6 months
- Recent (e.g., past 3 months, approximately) change in medications taken for psychiatric reasons
- Current, active suicidal thoughts or suicide attempt within the past year
- Current or past thought disorder or psychosis, or unmanaged bipolar disorder
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 |
|---|---|---|
| Healing HEARTSSession topics will include: psychoeducation; myths and stereotypes; cognitive distortions and restructuring; coping strategies; interpersonal effectiveness; self-efficacy; mindfulness and self-compassion; acceptance and positive self-image; disclosure and finding support; stigma in health care; and empowerment and advocacy. | Behavioural | Healing HEARTS Intervention |
| Peer SupportPeer support groups will cover general topics such as symptom management, stress, and social support. Stigma will not be a formal topic of discussion, and group leaders will be trained to avoid initiating conversations about stigma; however, to capture realistic discussions in peer support groups, participants will not be prohibited from discussing the topic should they bring it up. | Behavioural | Peer Support |
Primary outcome
Change in Internalized Health-Related Stigma Scale score at Week 12
Time frame: Baseline to Week 12
Estimated mean change score for the total scale (primary outcome) and three subscales (Perceived and Anticipated Stigma, Stereotype Application and Self-Devaluation, and Stigma Resistance); scale scores are averaged and range from 1-7, with higher scores indicating greater internalized health-related stigma.
21 secondary outcomes
Change in Internalized Health-Related Stigma Scale score at Week 26
Time frame: Baseline to Week 26
Change in Internalized Shame Scale score at Week 12
Time frame: Baseline to Week 12
Change in Internalized Shame Scale score at Week 26
Time frame: Baseline to Week 26
Change in UCLA Loneliness Scale score at Week 12
Time frame: Baseline to Week 12
Change in UCLA Loneliness Scale score at Week 26
Time frame: Baseline to Week 26
Change in Patient Health Questionnaire-9 score at Week 12
Time frame: Baseline to Week 12
Change in Patient Health Questionnaire-9 score at Week 26
Time frame: Baseline to Week 26
Change in Generalized Anxiety Disorder-7 Questionnaire score at Week 12
Time frame: Baseline to Week 12
Change in Generalized Anxiety Disorder-7 Questionnaire score at Week 26
Time frame: Baseline to Week 26
Change in Severity Measure for Social Anxiety Disorder score at Week 12
Time frame: Baseline to Week 12
Change in Severity Measure for Social Anxiety Disorder score at Week 26
Time frame: Baseline to Week 26
Change in 4-item Perceived Stress Scale score at Week 12
Time frame: Baseline to Week 12
Change in 4-item Perceived Stress Scale score at Week 26
Time frame: Baseline to Week 26
Change in General Self-Efficacy Scale score at Week 12
Time frame: Baseline to Week 12
Change in General Self-Efficacy Scale score at Week 26
Time frame: Baseline to Week 26
Change in Revised Illness Perceptions Questionnaire scores at Week 12
Time frame: Baseline to Week 12
Change in Revised Illness Perceptions Questionnaire scores at Week 26
Time frame: Baseline to Week 26
Change in SF-12v2 scores at Week 12
Time frame: Baseline to Week 12
Change in SF-12v2 scores at Week 26
Time frame: Baseline to Week 26
Change in CDC Healthy Days Core Measure at Week 12
Time frame: Baseline to Week 12
Change in CDC Healthy Days Core Measure at Week 26
Time frame: Baseline to Week 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes. Data will be shared via the National Institute of Mental Health (NIMH) Data Archive (NDA; https://nda.nih.gov).
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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.
Rebecca Pearl, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healing HEARTS and Peer Support in people with Obesity and Skin Disease, run by University of Florida 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 13 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 Internalized Health-Related Stigma Scale score at Week 12 (time frame: Baseline to Week 12). 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 16 Sep 2026.