BACKGROUND: Managing @entity5 And Living Meaningfully (CALM) is a brief individual psychotherapy for @entity1 with @entity5 . In an intervention-only phase 2a trial, CALM showed promising results, leading to the present 2b pilot, which introduces procedures for randomisation and improved rigour in preparation for a phase 3 randomised controlled trial (RCT). AIMS: To test trial methodology and assess feasibility of a confirmatory RCT. DESIGN: A parallel-arm RCT (intervention vs usual care) with 3 and 6-month follow-ups. Assessment of feasibility included rates of consent, randomisation, attrition, intervention non-compliance and usual care contamination. PRIMARY OUTCOME: depressive symptoms ( @entity1 Health Questionnaire-9; PHQ-9). SECONDARY OUTCOMES: @entity308 ( @entity308 ), generalised @entity148 , @entity204 @entity148 , spiritual well-being, @entity148 and avoidance, self-esteem, experiential avoidance, quality of life and post-traumatic growth. Bayesian conjugate analysis was used in this low-powered setting. SETTING/ @entity1 : 60 adult @entity1 with @entity5 from the Princess Margaret @entity5 Centre. RESULTS: Rate of consent was 32%, randomisation 78%, attrition 25%, non-compliance 37% and contamination 17%. There was support for potential treatment effects on: PHQ-9, OR=1.48, 95% Credible Interval (CRI.95) (0.65, 3.38); @entity308 , OR=1.56, CRI.95 (0.50, 4.84); @entity148 , OR=1.72, CRI.95 (0.73, 4.03); and attachment avoidance, OR=1.58, CRI.95 (0.67, 3.71). There was no support for effects on the seven remaining secondary outcomes. CONCLUSIONS: A phase 3 CALM RCT is feasible and should aim to detect effect sizes of d=0.40, with greater attention to issues of compliance and contamination. TRIAL REGISTRATION NUMBER: NCT02353546.

Managing @entity5 And Living Meaningfully (CALM): randomised feasibility trial in XXXX with @entity5 .

@entity1 :: ('9606', 'Species') :: ['patients', 'Patient', 'PARTICIPANTS'] @entity308 :: ('MESH:D003866', 'Disease') :: ['MDD', 'major depressive disorder'] @entity5 :: ('MESH:D009369', 'Disease') :: ['Cancer', 'advanced cancer'] @entity148 :: ('MESH:D001008', 'Disease') :: ['anxiety', 'attachment anxiety'] @entity204 :: ('MESH:D003643', 'Disease') :: ['death']
@entity1 :: (9606,Species) :: ['patients']
