(334) Who Are We Excluding? An RCT for Adults With Cystic Fibrosis That Includes Those With Moderate to Severe Symptoms of Depression and Anxiety

Background: Rates of anxiety and depression are 2-3 times higher in persons with CF than the general population, with annual screening of mental health symptoms now universal across CF centers, programs, and affiliates. Pre-pandemic mental health screening data from National Jewish Health, the University of North Carolina, and Johns Hopkins Medicine, indicated that up to 30% of adults with CF (awCF) reported moderate to severe anxiety or depression, and up to 11% reported some degree of suicidal ideation. Randomized controlled trials (RCTs) of interventions to improve mental health symptoms among awCF usually exclude individuals who report moderate to severe anxiety or depression, or who report suicidal ideation. Coping and Learning to Manage Stress in CF (CALM) is an RCT underway at the three aforementioned centers. It is inclusive of awCF reporting moderate to severe symptoms, including those reporting suicidal ideation. The current study has created a systematic screen to determine level of suicidal risk (low, medium, high) among those reporting suicidal ideation, with low risk awCF remaining eligible.

Methods: Baseline demographic and behavioral health screening data were examined for participants currently enrolled in CALM. One eligibility criterion is that the awCF must report mild, moderate, or severe symptoms on the Generalized Anxiety Disorder-7 (GAD-7) or Patient Health Questionnaire-9 (PHQ-9). For those endorsing suicidal ideation (scores > 0 on PHQ-9 item 9, “Thoughts you would be better off dead or of hurting yourself in some way”), study therapists administer a modified suicidal severity screener based on the Columbia-Suicide Severity Rating Scale (C-SSRS) to determine level of suicide risk (low, moderate, or high). Low risk awCF (ideation only, but no intent or plan) are permitted to enroll in the study. Moderate and high risk awCF (intent or plan; imminent safety needs) are excluded from enrolling and directed to a higher level of immediate care.

Results: Forty-five awCF have been randomized as of 3/5/22. Participants are mostly female (69%), White (89%), using psychotropic medication at baseline (62%), and using a CFTR modulator at baseline (87%). Mean age at baseline is 34 (SD=12), mean FEV1pp is 80 (SD=23), and mean BMI is 26 (SD=9). At baseline, nearly half of the sample reported moderate or severe symptoms of anxiety on the GAD-7 (47%) or the PHQ-9 (44%), and 13% reported suicidal ideation. Risk level for suicide was low in all instances of reported suicidal ideation, thus enrollment in CALM was permitted.

Conclusions: It is important to provide interventions to help awCF reporting moderate to severe symptoms of anxiety or depression. Endorsement of PHQ-9 item 9 does not necessarily equal suicidal intent or plan. Our systematic approach of assessing individuals that endorse suicidal ideation with follow-up questions aimed at determining level of suicide risk (low, moderate, or high) is feasible to implement and allows individuals who might benefit most from an intervention be included in the study. Since CALM is delivered by trained therapists, the study already includes personnel who have the training and ability to assess severity of suicidal ideation and refer to other resources if appropriate.

Acknowledgements: This work is supported by the Cystic Fibrosis Foundation [grant number: BATHGA21A0].

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