AsthmaNCT07895576
R34 Asthma Depression
A study testing SAMBA, Cognitive Behavioral Therapy-Asthma Depression (CBT-AD) and Original SAMBA in people with Asthma and Depression, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Depressive disorders are highly prevalent among older adults with asthma and are associated with poor asthma outcomes. The overall objective of this study is to integrate an asthma self-management support program that the research team previously developed with cognitive behavioral therapy (CBT) for adherence and… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Asthma, Depression
- What is being tested?
- SAMBA, Cognitive Behavioral Therapy-Asthma Depression (CBT-AD) and Original SAMBA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Aug 2028
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English and Spanish speaking adults
- Ages greater than or equal to 60 years
- Have physician diagnosis of asthma for a year or more
- Prescribed at least one asthma controller medication
- Current diagnosis of major depressive disorder (MDD) or persistent depressive disorder (PDD)
Who cannot join
- Diagnosis of COPD or other chronic respiratory illness
- History of smoking for greater than or equal to 15 years or packs throughout lifetime
- Use of CBT in the past 12 months
- Initiation or recent dose change of SSRI/SNRI within past 6 weeks
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
Icahn School of Medicine Mount Sinai
New York, New York, 10029
Jennifer Utkin, (212) 824-7980, jennifer.oschericianutkin@mountsinai.org
Juan Wisnivesky, MD
About this study
Official title: Integrated Intervention for Depression and Asthma Self-management in Older Adults
Depressive disorders are highly prevalent among older adults with asthma and are associated with poor asthma outcomes. The overall objective of this study is to integrate an asthma self-management support program that the research team previously developed with cognitive behavioral therapy (CBT) for adherence and depression for older adults with uncontrolled asthma and a comorbid depressive disorder. The research team will conduct a pilot randomized controlled trial to assess the feasibility and preliminary impact of the intervention on asthma and depression outcomes.
- Conditions
- Asthma, Depression
- Being tested
- SAMBA, Cognitive Behavioral Therapy-Asthma Depression (CBT-AD), Original SAMBA
- Keywords
- Asthma, Depression, CBT, Health Coach
- Medical subject headings
- Asthma, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAMBABehavioural
SAMBA will be utilized to support participants in establishing personalized goals, assessing symptoms, skills, and self-care activities, and identifying barriers to effective asthma self-management. The data collected through SAMBA will be used to inform and tailor CBT-AD intervention to each participant's needs.
The intervention will take place over 10 - 12 remote sessions, with additional telephone follow-up provided as needed.
Cognitive Behavioral Therapy-Asthma Depression (CBT-AD)Behavioural
CBT-AD (Cognitive Behavioral Therapy-Asthma Depression) will be delivered to identify and restructure thoughts related to depression and maladaptive beliefs surrounding disease management.
The intervention will take place over 10 - 12 remote sessions, with additional telephone follow-up provided as needed.
Original SAMBABehavioural
Participants in the control arm will receive the original SAMBA intervention only for asthma self-management support, without the adaptations for participants with depression and without the CBT-AD component.
| Study group | Role | What they receive |
|---|---|---|
| CBT-AD and SAMBA | Experimental | Participants will receive the SAMBA and CBT-AD intervention. Receives: Behavioral: SAMBA; Behavioral: Cognitive Behavioral Therapy-Asthma Depression (CBT-AD) |
| SAMBA Only | Active comparator | Participants will receive the original SAMBA intervention. Receives: Behavioral: Original SAMBA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Questionnaire (ACQ)
Asthma control will be assessed using the Asthma Control Questionnaire (ACQ). The ACQ is a measure used to assess asthma symptoms and activity limitations. Scores range from 0 - 6, with higher scores indicating greater asthma-related impairment and poorer asthma control.
Measured: Baseline and 3-months post-intervention
Geriatric Depression Scale (GDS)
Depressive symptoms will be assessed using the Geriatric Depression Scale (GDS). The GDS is a 30-item instrument designed to assess symptoms such as mood, energy, and social engagement. Scores range from 0 - 30, with higher scores indicating greater severity of depression.
Measured: Baseline and 3-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Yeshiva University
- Responsible party
- Principal investigator, Juan Wisnivesky, Icahn School of Medicine at Mount Sinai
- Investigators
- Juan Wisnivesky, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895576
- Sponsor's protocol ID
- STUDY-25-00825
- Other IDs
- 5R34HL179141
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All raw data produced in the course of the project will be preserved. Once primary study findings have been published, we will make de-identified data publicly available along with its associated documentation. In order to protect study participant confidentiality, requests for restricted use data sets will require a data use agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Intervention for Depression and Asthma Self-management in Older Adults
- ClinicalTrials.gov ID
- NCT07895576
- Acronym / sponsor ID
- STUDY-25-00825
- Conditions
- Asthma, Depression
- Keywords
- Asthma, Depression, CBT, Health Coach
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Yeshiva University
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 26 Oct 2026 (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.
Depressive disorders are highly prevalent among older adults with asthma and are associated with poor asthma outcomes. The overall objective of this study is to integrate an asthma self-management support program that the research team previously developed with cognitive behavioral therapy (CBT) for adherence and depression for older adults with uncontrolled asthma and a comorbid depressive disorder. The research team will conduct a pilot randomized controlled trial to assess the feasibility and preliminary impact of the intervention on asthma and depression outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-AD and SAMBA | Experimental | Behavioral: SAMBA, Behavioral: Cognitive Behavioral Therapy-Asthma Depression (CBT-AD)Participants will receive the SAMBA and CBT-AD intervention. |
| SAMBA Only | Active comparator | Behavioral: Original SAMBAParticipants will receive the original SAMBA intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- English and Spanish speaking adults
- Ages greater than or equal to 60 years
- Have physician diagnosis of asthma for a year or more
- Prescribed at least one asthma controller medication
- Current diagnosis of major depressive disorder (MDD) or persistent depressive disorder (PDD)
Key exclusion criteria (4 listed)
- Diagnosis of COPD or other chronic respiratory illness
- History of smoking for greater than or equal to 15 years or packs throughout lifetime
- Use of CBT in the past 12 months
- Initiation or recent dose change of SSRI/SNRI within past 6 weeks
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 |
|---|---|---|
| SAMBASAMBA will be utilized to support participants in establishing personalized goals, assessing symptoms, skills, and self-care activities, and identifying barriers to effective asthma self-management. The data collected through SAMBA will be used to inform and tailor CBT-AD intervention to each participant's needs. The intervention will take place over 10 - 12 remote sessions, with additional telephone follow-up provided as needed. | Behavioural | CBT-AD and SAMBA |
| Cognitive Behavioral Therapy-Asthma Depression (CBT-AD)CBT-AD (Cognitive Behavioral Therapy-Asthma Depression) will be delivered to identify and restructure thoughts related to depression and maladaptive beliefs surrounding disease management. The intervention will take place over 10 - 12 remote sessions, with additional telephone follow-up provided as needed. | Behavioural | CBT-AD and SAMBA |
| Original SAMBAParticipants in the control arm will receive the original SAMBA intervention only for asthma self-management support, without the adaptations for participants with depression and without the CBT-AD component. | Behavioural | SAMBA Only |
Primary outcome
Asthma Control Questionnaire (ACQ)
Time frame: Baseline and 3-months post-intervention
Asthma control will be assessed using the Asthma Control Questionnaire (ACQ). The ACQ is a measure used to assess asthma symptoms and activity limitations. Scores range from 0 - 6, with higher scores indicating greater asthma-related impairment and poorer asthma control.
Geriatric Depression Scale (GDS)
Time frame: Baseline and 3-months post-intervention
Depressive symptoms will be assessed using the Geriatric Depression Scale (GDS). The GDS is a 30-item instrument designed to assess symptoms such as mood, energy, and social engagement. Scores range from 0 - 30, with higher scores indicating greater severity of depression.
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 26 Oct 2026.
- Individual participant dataSharing planned: No. All raw data produced in the course of the project will be preserved. Once primary study findings have been published, we will make de-identified data publicly available along with its associated documentation. In order to protect study participant confidentiality, requests for restricted use data sets will require a data use agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
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Asthma
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.
Juan Wisnivesky, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAMBA, Cognitive Behavioral Therapy-Asthma Depression (CBT-AD) and Original SAMBA in people with Asthma and Depression, run by Icahn School of Medicine at Mount Sinai 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 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: opening soon, as of the sponsor's last update on 26 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.
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 Jennifer Utkin ((212) 824-7980, jennifer.oschericianutkin@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Questionnaire (ACQ) (time frame: Baseline and 3-months post-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 26 Oct 2026.