CFDB - Cystic Fibrosis DataBase

primary studies published RCT

Amikacin liposome inhalation suspension for chronic Pseudomonas aeruginosa infection in cystic fibrosis.

Study design (if review, criteria of inclusion for studies)

Randomized controlled trial

Participants

121 adults with cystic fibrosis (AWCF) with severe symptoms of depression and/or anxiety, including those endorsing suicidal ideation.

Interventions

Coping and Learning to Manage Stress with CF (CALM) is a manualized intervention for adults with cystic fibrosis (AWCF).

Outcome measures

Depression (Patient Health Questionnaire; PHQ-9) and/or anxiety (Generalized Anxiety Disorder-7; GAD-7) data. Established cut-points classified participants into four symptom severity groups (normal, mild, moderate, severe) for both depression and anxiety before participating in CALM.

Main results

Pre-CALM depression severity ranged from normal (n = 24) to severe (n = 11), with most participants reporting mild (n = 57) or moderate (n = 29) symptoms. Anxiety severity followed a similar distribution (normal=18; mild=59; moderate=27; severe=16), and 9% of participants reported suicidal ideation. AWCF reporting severe depression and/or anxiety symptoms before starting CALM showed statistically significant reductions in both depression and anxiety at the post, 1-month follow-up, and 3-month follow-up (p<.0001 for each comparison with the pre-CALM time point).

Authors' conclusions

AWCF with severe depression and/or anxiety symptoms showed significant symptom improvement following participation in CALM. This RCT is first to provide evidence of the efficacy of a stress management intervention to effectively treat severe depression and anxiety symptoms in AWCF.

Keywords: Adult; Child; Adolescent; Caregivers; Home; Home Care Services; non pharmacological intervention - psyco-soc-edu-org; telemedicine; Organization;