The real world mental health needs of heart failure patients are not reflected by the depression randomized controlled trial evidence

Introduction: International depression screening guidelines in heart failure (HF) are partly based on depression treatment efficacy from randomized controlled trials (RCTs). Our aim was to test the external validity of depression RCT criteria in a sample of real-world HF patients. Methods: HF patients admitted to 3 hospitals in South Australia were referred to a HF psychologist if not already receiving current psychiatric management by psychologist or psychiatrist elsewhere. Screening and referral protocol consisted of the following; (a). Patient Health Questionnaire $10; (b). Generalized Anxiety Disorder Questionnaire$7); (c). positive response to 1 item panic attack screener; (d). evidence of suicidality. Patients were evaluated against the most common RCT exclusion criteria personality disorder, high suicide risk, cognitive impairment, psychosis, alcohol or substance abuse or dependency, bi-polar depression. Results: Total 81 HF patients were referred from 404 HF admissions, and 73 were assessed (age 60.6613.4, 47.9% female). Nearly half (47%) met at least 1 RCT exclusion criterion, most commonly personality disorder (28.5%), alcohol/substance abuse (17.8%) and high suicide risk (11.0%). RCT ineligibility criteria was more frequent among patients with major depression (76.5% vs. 46.2%, p,.01) and dysthymia (26.5% vs. 7.7%, p = .03) but not significantly associated with anxiety disorders. RCT ineligible patients reported greater severity of depression (M = 16.665.0 vs. M = 12.967.2, p = .02) and were higher consumers of HF psychotherapy services (M = 11.564.7 vs. M = 8.564.8, p = .01). Conclusion: In this real-world sample comparable in size to recent RCT intervention arms, patients with depression disorders presented with complex psychiatric needs including comorbid personality disorders, alcohol/substance use and suicide risk. These findings suggest external validity of depression screening and RCTs could serve as a basis for level A guideline recommendations in cardiovascular diseases

Cardiovascular Health in Anxiety or Mood Problems Study (CHAMPS): study protocol for a randomized controlled trial

Background: Previous psychological and pharmacological interventions have primarily focused on depression disorders in populations with cardiovascular diseases (CVDs) and the efficacy of anxiety disorder interventions is only more recently being explored. Transdiagnostic interventions address common emotional processes and the full range of anxiety and depression disorders often observed in populations with CVDs. The aim of CHAMPS is to evaluate the feasibility of a unified protocol (UP) for the transdiagnostic treatment of emotional disorders intervention in patients recently hospitalized for CVDs. The current study reports the protocol of a feasibility randomized controlled trial to inform a future trial. Methods/Design: This is a feasibility randomized, controlled trial with a single-center design. A total of 50 participants will be block-randomized to either a UP intervention or enhanced usual care. Both groups will receive standard CVD care. The UP intervention consists of 1) enhancing motivation, readiness for change, and treatment engagement; (2) psychoeducation about emotions; (3) increasing present focused emotion awareness; (4) increasing cognitive flexibility; (5) identifying and preventing patterns of emotion avoidance and maladaptive emotion-driven behaviors (EDBs, including tobacco smoking, and alcohol use); (6) increasing tolerance of emotion-related physical sensations; (7) interoceptive and situation-based emotion-focused exposure; and (8) relapse prevention strategies. Treatment duration is 12 to 18 weeks. Relevant outcomes include the standard deviation of self-rated anxiety, depression and quality of life symptoms. Other outcomes include intervention acceptability, satisfaction with care, rates of EDBs, patient adherence, physical activity, cardiac and psychiatric readmissions. Parallel to the main trial, a nonrandomized comparator cohort will be recruited comprising 150 persons scoring below the predetermined depression and anxiety severity thresholds. Discussion: CHAMPS is designed to evaluate the UP for the transdiagnostic treatment of emotional disorders targeting emotional disorder processes in a CVD population. The design will provide preliminary evidence of feasibility, attrition, and satisfaction with treatment to design a definitive trial. If the trial is feasible, it opens up the possibility for interventions to target broader emotional processes in the precarious population with CVD and emotional distress

Cardiovascular Health in Anxiety or Mood Problems Study (CHAMPS): study protocol for a randomized controlled trial

Background: Previous psychological and pharmacological interventions have primarily focused on depression disorders in populations with cardiovascular diseases (CVDs) and the efficacy of anxiety disorder interventions is only more recently being explored. Transdiagnostic interventions address common emotional processes and the full range of anxiety and depression disorders often observed in populations with CVDs. The aim of CHAMPS is to evaluate the feasibility of a unified protocol (UP) for the transdiagnostic treatment of emotional disorders intervention in patients recently hospitalized for CVDs. The current study reports the protocol of a feasibility randomized controlled trial to inform a future trial. Methods/Design: This is a feasibility randomized, controlled trial with a single-center design. A total of 50 participants will be block-randomized to either a UP intervention or enhanced usual care. Both groups will receive standard CVD care. The UP intervention consists of 1) enhancing motivation, readiness for change, and treatment engagement; (2) psychoeducation about emotions; (3) increasing present focused emotion awareness; (4) increasing cognitive flexibility; (5) identifying and preventing patterns of emotion avoidance and maladaptive emotion-driven behaviors (EDBs, including tobacco smoking, and alcohol use); (6) increasing tolerance of emotion-related physical sensations; (7) interoceptive and situation-based emotion-focused exposure; and (8) relapse prevention strategies. Treatment duration is 12 to 18 weeks. Relevant outcomes include the standard deviation of self-rated anxiety, depression and quality of life symptoms. Other outcomes include intervention acceptability, satisfaction with care, rates of EDBs, patient adherence, physical activity, cardiac and psychiatric readmissions. Parallel to the main trial, a nonrandomized comparator cohort will be recruited comprising 150 persons scoring below the predetermined depression and anxiety severity thresholds. Discussion: CHAMPS is designed to evaluate the UP for the transdiagnostic treatment of emotional disorders targeting emotional disorder processes in a CVD population. The design will provide preliminary evidence of feasibility, attrition, and satisfaction with treatment to design a definitive trial. If the trial is feasible, it opens up the possibility for interventions to target broader emotional processes in the precarious population with CVD and emotional distress.Phillip J. Tully, Deborah A. Turnbull, John D. Horowitz, John F. Beltrame, Terina Selkow, Bernhard T. Baune, Elizabeth Markwick, Shannon Sauer-Zavala, Harald Baumeister, Suzanne Cosh and Gary A. Witter

A dynamic view of comorbid depression and generalized anxiety disorder symptom change in chronic heart failure: The discrete effects of cognitive behavioral therapy, exercise, and psychotropic medication

Purpose: No previous study has reported upon comorbid depression and anxiety disorders and their treatment in heart failure (HF), which the current study has sought to document. Materials and methods: Total 29 HF patients under psychiatric management underwent primary depression cognitive behavioral therapy (CBT; n = 15) or primary generalized anxiety disorder (GAD) CBT (n = 14), and participated in a community exercise program and standard physician care. Repeated measures analysis of variance assessed Patient Health Questionnaire (PHQ-9) and GAD-7 symptom change pre- and post-CBT treatment, and assessed the interaction effects of treatment type, exercise, anti-depressant and anxiolytic. Results: There was a significant time and treatment interaction effect that favored the primary GAD CBT group for reduction in PHQ symptoms (F(1, 24) = 4.52, p = 0.04). Analysis of PHQ-somatic symptoms also showed a significant main effect for participation in the exercise program (F(1, 24) = 4.21, p = 0.05) and a significant time and anxiolytic interaction (F(1, 24) = 3.98, p = 0.05). The average number of cardiac hospital readmissions favored the primary GAD CBT group (p = 0.05). Conclusion: The findings support the use of multifaceted interventions in the rehabilitation of HF patients with comorbid psychiatric needs

Prevalence of depression and anxiety disorders in heart failure patients referred for psychiatric care.

<p><i>RCT, randomized controlled trial; SCID, Structured Clinical Interview.</i></p>*<p><i>p<.05.</i></p

Comparison of RCT eligible and ineligible patients on demographics and medical comorbidity.

<p><i>NYHA, New York Heart Association; RCT, randomized controlled trial.</i></p>*<p><i>p<.05.</i></p

Psychiatric RCT ineligibility in heart failure patients referred for psychiatric care according to depression status.

<p><i>RCT, randomized controlled trial.</i></p>*<p><i>p<.05.</i></p

Proportion of standard RCT exclusion criteria met by HF patients according to depression status (yes vs. no).

<p>Proportion of standard RCT exclusion criteria met by HF patients according to depression status (yes vs. no).</p

Flow chart of patients through the study.

<p>Flow chart of patients through the study.</p

Comparison of RCT eligible and ineligible patients on clinical psychiatric characteristics.

<p><i>GAD, Generalized Anxiety Disorder; PHQ, Patient Health Questionnaire; RCT, randomized controlled trial.</i></p>*<p><i>p<.05.</i></p>a<p><i>Medical records depression and medical records anxiety inclusive of diagnoses that conflicts with psychologist SCID assessment. Medical records missing depression or anxiety diagnosis evaluates medical record comorbidity lists and hospital discharge summaries in preceding 6 months prior to assessment with the SCID diagnosis.</i></p