An interventional study of SAMBA and Cognitive Behavioral Therapy-Asthma Depression (CBT-AD) in Asthma and Depression, sponsored by Icahn School of Medicine at Mount Sinai. Not yet recruiting at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
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.
4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's planned enrollment of 60 is below the median of 83 across 2,814 interventional studies indexed under Asthma.
Browse Asthma studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 773 studies on the registry; 176 are open to participants now.
Of its 124 completed or terminated interventional studies of FDA-regulated products, 83 (67%) have results posted.
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Exclusion Criteria:
Participants will receive the SAMBA and CBT-AD intervention.
Behavioral: SAMBA · Behavioral: Cognitive Behavioral Therapy-Asthma Depression (CBT-AD)
Participants will receive the original SAMBA intervention.
Behavioral: Original SAMBA
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.
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.
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.
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.
Time frame: 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.
Time frame: Baseline and 3-months post-intervention
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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