Breast Cancer FemalePhase 2NCT05676255
The Breast Cancer Survivors and Partners Online Research Together (SUPORT) Project
A Phase 2 study testing Cognitively-Based Compassion Training for Survivors, Cognitively-Based Compassion Training for Dyads and Health Education in people with Breast Cancer Female and Psychological Distress, run by University of Arizona at 1 site in United States.
Trial summary
Many breast cancer survivors (estimated 70% in some studies) experience clinically significant depression and/or anxiety in the months and years after finishing cancer treatments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female, Psychological Distress
- What is being tested?
- Cognitively-Based Compassion Training for Survivors, Cognitively-Based Compassion Training for Dyads and Health Education
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2023to Jun 2027
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- biological sex: woman
- able to speak and understand English
- have a diagnosis of a breast cancer
- have completed primary curative cancer treatments (i.e., surgery, radiation, chemotherapy) except for hormonal therapies (e.g., aromatase inhibitors) or trastuzumab a minimum of 3 months and a maximum of 5 years before starting CBCT or the control
- have a supportive partner (aka caregiver) who can participate with them
- named by the survivor
- live in the same household as the survivor
- able to speak and understand English
Who cannot join
- nursing home resident
- have ongoing (1 or more meditation sessions per week) or past regular meditation experience in the last 4 years (i.e., more than two meditation sessions [completed or attempted] per year, either with a group or individually, to be evaluated by the Principal Investigator)
- Supportive partners (aka informal caregivers)
- have ongoing (1 or more meditation sessions per week) or past regular meditation experience in the last 4 years (i.e., more than two meditation sessions [completed or attempted] per year, either with a group or individually, to be evaluated by the Principal Investigator)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arizona
Tucson, Arizona, 85721
Jacquelyn Martin, 520-621-1930, UArizona-SUPORT@email.arizona.edu
About this study
Official title: The SUPORT Project: Leveraging Social Connection by Including Informal Caregivers in an Internet Video Conference-based Compassion Meditation Intervention to Reduce Psychological Distress in Breast Cancer Survivors
Many breast cancer survivors (estimated 70% in some studies) experience clinically significant depression and/or anxiety in the months and years after finishing cancer treatments. This research will build on the rigor of prior research to reduce breast cancer survivor depression and anxiety with a compassion meditation intervention called CBCT (Cognitively-Based Compassion Training) for online synchronous delivery that is also inclusive of informal caregivers (i.e., adult family members who live with and typically provide half the care for survivors, aka supportive partners).
Read the detailed description
The goal of this project is to determine if CBCT (Cognitively-Based Compassion Training) can reduce distress for survivors compared to an attention control (Health Education; HE) when delivered by Zoom to both survivors and caregivers/ supportive partners as a dyad (i.e., CBCT for dyads; CBCT-D). We will also test whether instructing survivors and caregivers/ supportive partners together in CBCT (CBCT-D) reduces distress more than when survivors receive CBCT instruction by themselves, without caregivers/ supportive partners (i.e., CBCT for survivors; CBCT-S). The following specific aims address these questions:
Aim 1: Determine if survivors and caregivers/ supportive partners exhibit less depression and anxiety (primary outcomes) when survivors receive online CBCT along with their informal caregiver// supportive partner (CBCT-D), compared to when survivors receive online CBCT alone (CBCT-S) or when survivors and informal caregivers// supportive partners receive online HE. We will recruit dyads (N=226) consisting of survivors (between 3 months and 5 years post treatments with curative intent, i.e., chemotherapy, radiation, surgery) and their caregivers/ supportive partners. H1: Survivors and caregivers randomized to CBCT-D will exhibit greater improvements in distress (i.e., depression, anxiety; primary outcomes in survivors) at months 2, 3, and 8 versus those randomized to CBCT-S or HE.
Aim 2: Test the extent to which reductions in survivor's depression and anxiety from online CBCT-D are mediated by social connection, dyadic function, and caregiver/ supportive partner distress. H2a: Survivor's social connection and dyadic function will mediate the effects of online CBCT-D versus HE on survivor's distress at months 2, 3 and 8. H2b: Caregiver's social connection, dyadic function, and distress will mediate the effects of CBCT-D versus CBCT-S or HE on survivor's distress.
Aim 3: Explore the effects of online CBCT-D versus CBCT-S and HE on survivor diurnal cortisol rhythm at months 2, 3 and 8, and the extent to which cortisol rhythm is a marker versus mediator of improvements in survivor's distress at month 2, 3, and 8.
- Conditions
- Breast Cancer Female, Psychological Distress
- Being tested
- Cognitively-Based Compassion Training for Survivors, Cognitively-Based Compassion Training for Dyads, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitively-Based Compassion Training for SurvivorsBehavioural
Also called CBCT-S
CBCT-S is a secular adaptation of techniques derived from traditional Tibetan Buddhist methods for cultivating compassion known as lo-jong. CBCT-S will be administered to breast cancer survivors and will not including supportive partners.
Module 1 (Week 1): Overview and Connecting to A Moment of Nurturance
Module 2 (Week 2) Developing Stable and Clear Attention
Module 3 (Week 3): Enhancing Self Awareness
Module 4 (Week 4): Cultivating Self compassion Part 1: Accepting our Suffering
Module 5 (Week 5): Self Compassion Part 2: Finding Meaning in Suffering.
Module 6(Week 6): Expanding our Circle of Concern
Module 7 (Week 7): Deepening Gratitude and Tenderness
Module 8 (Week 8): Harnessing the Power of Compassion
Cognitively-Based Compassion Training for DyadsBehavioural
Also called CBCT-D
CBCT-D is a secular adaptation of techniques derived from traditional Tibetan Buddhist methods for cultivating compassion known as lo-jong. CBCT-D will be administered to breast cancer survivors and supportive partners together.
Module 1 (Week 1): Overview and Connecting to A Moment of Nurturance
Module 2 (Week 2) Developing Stable and Clear Attention
Module 3 (Week 3): Enhancing Self Awareness
Module 4 (Week 4): Cultivating Self compassion Part 1: Accepting our Suffering
Module 5 (Week 5): Self Compassion Part 2: Finding Meaning in Suffering.
Module 6(Week 6): Expanding our Circle of Concern
Module 7 (Week 7): Deepening Gratitude and Tenderness
Module 8 (Week 8): Harnessing the Power of Compassion
Health EducationBehavioural
Also called HE
HE focuses on topics relevant to health and cancer, but is also intended for individuals who are not cancer survivors themselves.
HE will be administered to both breast cancer survivors and supportive partners together.
Module I (Week 1): Cancer Advocacy.
Module II (Week 2): Health Through the Lifespan.
Module III (Week 3): Nutrition.
Module III (Week 4): Nutrition.
Module IV (Week 5): Physical Activity.
Module V (Week 6): Sleep.
Module VI (Week 7): Stress.
Module VII (Week 8): Mental Health and Social Support.
| Study group | Role | What they receive |
|---|---|---|
| Cognitively-Based Compassion Training for Survivors (CBCT-S) | Experimental | CBCT-S is a secular adaptation of techniques derived from traditional Tibetan Buddhist methods for cultivating compassion known as lo-jong. CBCT-S will be administered to breast cancer survivors and will not including supportive partners.
Module 1 (Week 1): Overview and Connecting to A Moment of Nurturance
Module 2 (Week 2) Developing Stable and Clear Attention
Module 3 (Week 3): Enhancing Self Awareness
Module 4 (Week 4): Cultivating Self compassion Part 1: Accepting our Suffering
Module 5 (Week 5): Self Compassion Part 2: Finding Meaning in Suffering.
Module 6(Week 6): Expanding our Circle of Concern
Module 7 (Week 7): Deepening Gratitude and Tenderness
Module 8 (Week 8): Harnessing the Power of Compassion Receives: Behavioral: Cognitively-Based Compassion Training for Survivors |
| Cognitively-Based Compassion Training for Dyads (CBCT-D) | Experimental | CBCT-D is a secular adaptation of techniques derived from traditional Tibetan Buddhist methods for cultivating compassion known as lo-jong. CBCT-D will be administered to breast cancer survivors and supportive partners together.
Module 1 (Week 1): Overview and Connecting to A Moment of Nurturance
Module 2 (Week 2) Developing Stable and Clear Attention
Module 3 (Week 3): Enhancing Self Awareness
Module 4 (Week 4): Cultivating Self compassion Part 1: Accepting our Suffering
Module 5 (Week 5): Self Compassion Part 2: Finding Meaning in Suffering.
Module 6(Week 6): Expanding our Circle of Concern
Module 7 (Week 7): Deepening Gratitude and Tenderness
Module 8 (Week 8): Harnessing the Power of Compassion Receives: Behavioral: Cognitively-Based Compassion Training for Dyads |
| Health Education | Active comparator | HE focuses on topics relevant to health and cancer, but is also intended for individuals who are not cancer survivors themselves.
HE will be administered to both breast cancer survivors and supportive partners together.
Module I (Week 1): Cancer Advocacy.
Module II (Week 2): Health Through the Lifespan.
Module III (Week 3): Nutrition.
Module III (Week 4): Nutrition.
Module IV (Week 5): Physical Activity.
Module V (Week 6): Sleep.
Module VI (Week 7): Stress.
Module VII (Week 8): Mental Health and Social Support. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression features
The difference in the change in depression features between the intervention arms from before to 8 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Depression - 8a.
Measured: Change from baseline depression to 8 weeks after the start of intervention
Change in anxiety features
The difference in the change in anxiety features between the intervention arms from before to 8 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Anxiety - 8a.
Measured: Change from baseline anxiety to 8 weeks after the start of intervention
Secondary outcomes (4)
Change in depression features
The difference in the change in depression features between the intervention arms from before to 12 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Depression - 8a.
Measured: Change from baseline depression to 12 weeks after the start of intervention
Change in anxiety features
The difference in the change in anxiety features between the intervention arms from before to 12 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Anxiety - 8a.
Measured: Change from baseline anxiety to 12 weeks after the start of intervention
Change in depression features
The difference in the change in depression features between the intervention arms from before to 32 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Depression - 8a.
Measured: Change from baseline depression to 32 weeks after the start of intervention
Change in anxiety features
The difference in the change in anxiety features between the intervention arms from before to 32 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Anxiety - 8a.
Measured: Change from baseline anxiety to 32 weeks after the start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start20 Mar 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 452 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Thaddeus Pace, University of Arizona
- Investigators
- Thaddeus Pace, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676255
- Sponsor's protocol ID
- STUDY00001225
- Other IDs
- R01CA264047
- Status last verified
- Oct 2026
- First submitted
- 22 Dec 2022
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not applicable as of current version date
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SUPORT Project: Leveraging Social Connection by Including Informal Caregivers in an Internet Video Conference-based Compassion Meditation Intervention to Reduce Psychological Distress in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05676255
- Acronym / sponsor ID
- STUDY00001225
- Conditions
- Breast Cancer Female, Psychological Distress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 452 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Jan 2023 (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.
Many breast cancer survivors (estimated 70% in some studies) experience clinically significant depression and/or anxiety in the months and years after finishing cancer treatments. This research will build on the rigor of prior research to reduce breast cancer survivor depression and anxiety with a compassion meditation intervention called CBCT (Cognitively-Based Compassion Training) for online synchronous delivery that is also inclusive of informal caregivers (i.e., adult family members who live with and typically provide half the care for survivors, aka supportive partners).
Detailed description
The goal of this project is to determine if CBCT (Cognitively-Based Compassion Training) can reduce distress for survivors compared to an attention control (Health Education; HE) when delivered by Zoom to both survivors and caregivers/ supportive partners as a dyad (i.e., CBCT for dyads; CBCT-D). We will also test whether instructing survivors and caregivers/ supportive partners together in CBCT (CBCT-D) reduces distress more than when survivors receive CBCT instruction by themselves, without caregivers/ supportive partners (i.e., CBCT for survivors; CBCT-S). The following specific aims address these questions:
Aim 1: Determine if survivors and caregivers/ supportive partners exhibit less depression and anxiety (primary outcomes) when survivors receive online CBCT along with their informal caregiver// supportive partner (CBCT-D), compared to when survivors receive online CBCT alone (CBCT-S) or when survivors and informal caregivers// supportive partners receive online HE. We will recruit dyads (N=226) consisting of survivors (between 3 months and 5 years post treatments with curative intent, i.e., chemotherapy, radiation, surgery) and their caregivers/ supportive partners. H1: Survivors and caregivers randomized to CBCT-D will exhibit greater improvements in distress (i.e., depression, anxiety; primary outcomes in survivors) at months 2, 3, and 8 versus those randomized to CBCT-S or HE.
Aim 2: Test the extent to which reductions in survivor's depression and anxiety from online CBCT-D are mediated by social connection, dyadic function, and caregiver/ supportive partner distress. H2a: Survivor's social connection and dyadic function will mediate the effects of online CBCT-D versus HE on survivor's distress at months 2, 3 and 8. H2b: Caregiver's social connection, dyadic function, and distress will mediate the effects of CBCT-D versus CBCT-S or HE on survivor's distress.
Aim 3: Explore the effects of online CBCT-D versus CBCT-S and HE on survivor diurnal cortisol rhythm at months 2, 3 and 8, and the extent to which cortisol rhythm is a marker versus mediator of improvements in survivor's distress at month 2, 3, and 8.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized clinical trial design
| Arm | Type | Receives |
|---|---|---|
| Cognitively-Based Compassion Training for Survivors (CBCT-S) | Experimental | Behavioral: Cognitively-Based Compassion Training for SurvivorsCBCT-S is a secular adaptation of techniques derived from traditional Tibetan Buddhist methods for cultivating compassion known as lo-jong. CBCT-S will be administered to breast cancer survivors and will not including supportive partners. Module 1 (Week 1): Overview and Connecting to A Moment of Nurturance Module 2 (Week 2) Developing Stable and Clear Attention Module 3 (Week 3): Enhancing Self Awareness Module 4 (Week 4): Cultivating Self compassion Part 1: Accepting our Suffering Module 5 (Week 5): Self Compassion Part 2: Finding Meaning in Suffering. Module 6(Week 6): Expanding our Circle of Concern Module 7 (Week 7): Deepening Gratitude and Tenderness Module 8 (Week 8): Harnessing the Power of Compassion |
| Cognitively-Based Compassion Training for Dyads (CBCT-D) | Experimental | Behavioral: Cognitively-Based Compassion Training for DyadsCBCT-D is a secular adaptation of techniques derived from traditional Tibetan Buddhist methods for cultivating compassion known as lo-jong. CBCT-D will be administered to breast cancer survivors and supportive partners together. Module 1 (Week 1): Overview and Connecting to A Moment of Nurturance Module 2 (Week 2) Developing Stable and Clear Attention Module 3 (Week 3): Enhancing Self Awareness Module 4 (Week 4): Cultivating Self compassion Part 1: Accepting our Suffering Module 5 (Week 5): Self Compassion Part 2: Finding Meaning in Suffering. Module 6(Week 6): Expanding our Circle of Concern Module 7 (Week 7): Deepening Gratitude and Tenderness Module 8 (Week 8): Harnessing the Power of Compassion |
| Health Education | Active comparator | Behavioral: Health EducationHE focuses on topics relevant to health and cancer, but is also intended for individuals who are not cancer survivors themselves. HE will be administered to both breast cancer survivors and supportive partners together. Module I (Week 1): Cancer Advocacy. Module II (Week 2): Health Through the Lifespan. Module III (Week 3): Nutrition. Module III (Week 4): Nutrition. Module IV (Week 5): Physical Activity. Module V (Week 6): Sleep. Module VI (Week 7): Stress. Module VII (Week 8): Mental Health and Social Support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- biological sex: woman
- able to speak and understand English
- have a diagnosis of a breast cancer
- have completed primary curative cancer treatments (i.e., surgery, radiation, chemotherapy) except for hormonal therapies (e.g., aromatase inhibitors) or trastuzumab a minimum of 3 months and a maximum of 5 years before starting CBCT or the control
- have a supportive partner (aka caregiver) who can participate with them
Key exclusion criteria (4 listed)
- nursing home resident
- have ongoing (1 or more meditation sessions per week) or past regular meditation experience in the last 4 years (i.e., more than two meditation sessions [completed or attempted] per year, either with a group or individually, to be evaluated by the Principal Investigator)
- Supportive partners (aka informal caregivers)
- have ongoing (1 or more meditation sessions per week) or past regular meditation experience in the last 4 years (i.e., more than two meditation sessions [completed or attempted] per year, either with a group or individually, to be evaluated by the Principal Investigator)
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 |
|---|---|---|
| Cognitively-Based Compassion Training for SurvivorsAlso: CBCT-SCBCT-S is a secular adaptation of techniques derived from traditional Tibetan Buddhist methods for cultivating compassion known as lo-jong. CBCT-S will be administered to breast cancer survivors and will not including supportive partners. Module 1 (Week 1): Overview and Connecting to A Moment of Nurturance Module 2 (Week 2) Developing Stable and Clear Attention Module 3 (Week 3): Enhancing Self Awareness Module 4 (Week 4): Cultivating Self compassion Part 1: Accepting our Suffering Module 5 (Week 5): Self Compassion Part 2: Finding Meaning in Suffering. Module 6(Week 6): Expanding our Circle of Concern Module 7 (Week 7): Deepening Gratitude and Tenderness Module 8 (Week 8): Harnessing the Power of Compassion | Behavioural | Cognitively-Based Compassion Training for Survivors (CBCT-S) |
| Cognitively-Based Compassion Training for DyadsAlso: CBCT-DCBCT-D is a secular adaptation of techniques derived from traditional Tibetan Buddhist methods for cultivating compassion known as lo-jong. CBCT-D will be administered to breast cancer survivors and supportive partners together. Module 1 (Week 1): Overview and Connecting to A Moment of Nurturance Module 2 (Week 2) Developing Stable and Clear Attention Module 3 (Week 3): Enhancing Self Awareness Module 4 (Week 4): Cultivating Self compassion Part 1: Accepting our Suffering Module 5 (Week 5): Self Compassion Part 2: Finding Meaning in Suffering. Module 6(Week 6): Expanding our Circle of Concern Module 7 (Week 7): Deepening Gratitude and Tenderness Module 8 (Week 8): Harnessing the Power of Compassion | Behavioural | Cognitively-Based Compassion Training for Dyads (CBCT-D) |
| Health EducationAlso: HEHE focuses on topics relevant to health and cancer, but is also intended for individuals who are not cancer survivors themselves. HE will be administered to both breast cancer survivors and supportive partners together. Module I (Week 1): Cancer Advocacy. Module II (Week 2): Health Through the Lifespan. Module III (Week 3): Nutrition. Module III (Week 4): Nutrition. Module IV (Week 5): Physical Activity. Module V (Week 6): Sleep. Module VI (Week 7): Stress. Module VII (Week 8): Mental Health and Social Support. | Behavioural | Health Education |
Primary outcome
Change in depression features
Time frame: Change from baseline depression to 8 weeks after the start of intervention
The difference in the change in depression features between the intervention arms from before to 8 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Depression - 8a.
Change in anxiety features
Time frame: Change from baseline anxiety to 8 weeks after the start of intervention
The difference in the change in anxiety features between the intervention arms from before to 8 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Anxiety - 8a.
4 secondary outcomes
Change in depression features
Time frame: Change from baseline depression to 12 weeks after the start of intervention
Change in anxiety features
Time frame: Change from baseline anxiety to 12 weeks after the start of intervention
Change in depression features
Time frame: Change from baseline depression to 32 weeks after the start of intervention
Change in anxiety features
Time frame: Change from baseline anxiety to 32 weeks after the start of intervention
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 8 Oct 2026.
- Individual participant dataSharing planned: No. not applicable as of current version date
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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.
Thaddeus Pace, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitively-Based Compassion Training for Survivors, Cognitively-Based Compassion Training for Dyads and Health Education in people with Breast Cancer Female and Psychological Distress, run by University of Arizona 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 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jacquelyn Martin (520-621-1930, UArizona-SUPORT@email.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression features (time frame: Change from baseline depression to 8 weeks after the start of intervention). 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 8 Oct 2026.