An attachment-based intervention for patients with cardiovascular disease and their partners: A proof-of-concept study.

Couple distress is associated with cardiovascular disease (CVD) risk factors, whereas support is associated with heart-healthy behaviors and better CVD outcomes. OBJECTIVE: To assess the clinical benefit of the Healing Hearts Together (HHT) intervention, an attachment-based relationship enhancement program for couples in which 1 partner has CVD, on relationship quality, mental health, and quality of life (QoL). METHOD: Patients from a tertiary cardiac care center and their partners (N = 78; 39 couples) attended the 8-session HHT group. Participants completed validated, self-report questionnaires pre- and postintervention, including the Dyadic Adjustment Scale (DAS), Couple Satisfaction Index (CSI), Hospital Anxiety and Depression Scale (HADS), and the SF-36 (QoL). At intervention completion, participants completed a satisfaction survey. Between-groups comparisons (patient/partner) were examined with analysis of variance. Paired-sample t tests were used to assess changes over time with HHT participation for the complete sample and for patients and partners separately. RESULTS: Many participants reported relationship and psychological distress at baseline. Clinically and statistically significant changes from pre to postintervention were observed for relationship distress (DAS: +7.8 points; p < .001; CSI changes [+3.6] were clinically significant) and depression (-1.8; p < .001), whereas statistically significant changes occurred for anxiety (-1.5; p < .001), and physical (+2.1; p = .047) and mental (+3.3; p < .001) QoL. Patients, but not partners, reported statistically significant changes in QoL-mental component summary. Clinically and statistically significant changes were observed for anxiety for partners, but not patients. CONCLUSIONS: The HHT intervention was beneficial for patients' and partners' relationship quality, mental health, and QoL. A larger randomized controlled trial evaluating the impact of this intervention on relationship quality, mental health and QoL is warranted. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Learning a new way of living together: a qualitative study exploring the relationship changes and intervention needs of patients with cardiovascular disease and their partners.

OBJECTIVES: Cardiovascular disease (CVD) not only affects the patient, but has implications for the partner. Emerging evidence suggests that supportive couple relationships enhance CVD outcomes and reduce patient and partner distress. To date, however, little research has been done to address the couple relationship as a potentially important component of cardiac care. This article examines the impact of CVD on the couple relationship and assesses the perceived needs and desired intervention components of patients with CVD and their partners. DESIGN: Qualitative study using directed and conventional content analysis. SETTING: Single-centre, tertiary cardiac care hospital that serves a population of 1.4 million in the Champlain region of Ontario, Canada. PARTICIPANTS: Patients with CVD and their partners (n=32, 16 couples) participated in focus groups. Patients were mainly male (75%), white (87.5%), aged 64.4 years (range 31-81 years), with varied cardiac diagnoses (50% coronary artery disease; 18.75% valve disease; 18.75% heart failure; 12.5% arrhythmia). RESULTS: Five categories were generated from the data reflecting changes within the couple relationship as a result of CVD: (1) emotional and communication disconnection; (2) overprotection of the patient; (3) role changes; (4) adjustment to lifestyle changes; and (5) positive relationship changes. Three categories were constructed regarding intervention needs and desired resources: (1) practical resources; (2) sharing with peers; and (3) relationship enhancement. CONCLUSIONS: Overall, the data suggest that there were profound changes in the couple relationship as a result of CVD, and that there is considerable need to better support the caregiving spouses and the couple as a unit. These results call for interventions designed to provide instrumental support, peer-sharing opportunities and relationship quality enhancement to help couples cope with CVD. Future studies should examine whether couples-based programming embedded into cardiac rehabilitation can be effective at improving relationship quality and reducing patient and partner stress in the aftermath of a cardiac event.

A bidirectional path analysis model of smoking cessation self-efficacy and concurrent smoking status: impact on abstinence outcomes.

Self-efficacy is routinely associated with abstinence in the addictions literature, and is a major component relapse-prevention models. The magnitude of this relationship has been brought into question following equivocal results in studies controlling for concurrent smoking status. The aim of our study was to clarify the relationship between cessation self-efficacy, smoking status, and cessation outcomes in a cohort of treatment-seeking smokers. Smokers participating in the FLEX trial, a randomized trial investigating the efficacy of three pharmacologic treatments for smoking cessation, completed questionnaires assessing cessation self-efficacy at baseline and at weeks 1, 3, 5 and 10 post-target quit date; smoking status was verified using expired carbon monoxide. Structural models were fit in order to ascertain the relationship between cessation self-efficacy and concurrent smoking at each time-point, and to assess the association between cessation self-efficacy, smoking and seven-day point prevalence smoking status at week 10. A total of 737 treatment-seeking smokers participated. In our path model, self-efficacy and smoking status at all time points were associated with week 10 abstinence (except week 3 self-efficacy), after controlling these values' previous time-points. All direct pathways between cessation self-efficacy and smoking were also significant, supporting a bidirectional relationship. Our results support a bidirectional and reciprocal relationship between cessation self-efficacy and concurrent smoking behavior; participants with higher confidence were more likely to be smoke-free, and concurrent smoking status predicted levels of confidence over the ensuing weeks. Both measures were associated with week 10 abstinence. Our results indicate that while correlated, both cessation self-efficacy and current smoking behavior during a cessation attempt are important independent markers of ultimate cessation success.

Nicotine metabolite ratio and smoking outcomes using nicotine replacement therapy and varenicline among smokers with and without psychiatric illness.

INTRODUCTION: It has been suggested that the effectiveness of nicotine replacement smoking cessation pharmacotherapy may be enhanced by assessing rates of nicotine metabolism using the nicotine metabolite ratio - which reflects differences in the activity of the CYP2A6 hepatic enzyme - and titrating doses appropriately. To date, supporting evidence is equivocal, with little information regarding the assessment and effectiveness of the nicotine metabolite ratio among smokers with psychiatric conditions. METHODS: The nicotine metabolite ratio of 499 smokers from the FLEX trial was determined using urine samples obtained at baseline. They were randomized to receive either: standard transdermal nicotine (nicotine replacement therapy); extended nicotine replacement therapy + adjunct nicotine agent; or varenicline. Primary cessation outcomes were seven-day point prevalence at 5, 10, 22, and 52 weeks post-target quit date, comparing across treatment and psychiatric status. Our principal analysis employed logistic regression (outcome: abstinence), using slow metabolizers as the reference category. RESULTS: No differences were observed by nicotine metabolite ratio classification (slow, moderate, fast) with respect to any demographic or smoking-related variables. Nicotine metabolite ratio class did not predict smoking cessation in either the overall sample, or by treatment condition at any time-point (week 52 moderate metabolizers: odds ratio 1.34, 95% confidence interval (0.68-2.63), p=0.394; fast metabolizers: odds ratio 1.04 (0.56-1.91), p=0. 906). CONCLUSION: Our results did not find any associations between nicotine metabolite ratio and cessation outcomes among smokers using nicotine replacement therapy or varenicline with and without lifetime psychiatric conditions.

Factor structure of the Smoking Cessation Self-Efficacy Questionnaire among smokers with and without a psychiatric diagnosis.

Cessation self-efficacy has been shown to be a consistent predictor of smoking cessation outcomes. To date, no scale assessing cessation self-efficacy has been validated across smokers with and without a psychiatric diagnosis (current or past). Smokers with a psychiatric diagnosis are typically heavy smokers, have a more difficult time quitting, and are more prone to experience lower self-efficacy. Determining whether smoking cessation self-efficacy scores are invariant across these populations is crucial for future research and intervention strategies. Data from the Flexible and Extended Dosing of Nicotine Replacement Therapy (NRT) and Varenicline in Comparison to Fixed Dose NRT for Smoking Cessation: The FLEX Trial, a randomized control trial for smoking cessation, was used to assess the factor structure of the Smoking Cessation Self-Efficacy Questionnaire (SEQ-12), a 12-item scale assessing an individual's confidence to refrain from smoking. Confirmatory factor analysis (CFA) was used to compare the model's fit between the original factor structure and the present data, and to test for measurement invariance across with a current, past, or no psychiatric diagnosis. Initial support was found for both a 2- and 3-factor structure. Using CFA, only the 3-factor model displayed adequate fit indices (Global Fit Index [GFI] = 0.924). Results from the model comparisons showed no differences between those with a current, past, or no psychiatric diagnosis (cmin (30) = 38.64, p = .134). The 3 factors were highly correlated, indicative of an underlying global factor. The SEQ-12 was found to be measurement invariant across treatment-seeking smokers, with preliminary evidence suggesting it is a valid measurement scale for evaluating overall cessation self-efficacy, regardless of psychiatric status. (PsycINFO Database Record

Flexible, dual-form nicotine replacement therapy or varenicline in comparison with nicotine patch for smoking cessation: a randomized controlled trial.

BACKGROUND: Extended use of combined pharmacotherapies to treat tobacco dependence may increase smoking abstinence; few studies have examined their effectiveness. The objective of this study was to evaluate smoking abstinence with standard nicotine patch (NRT), extended use of combined formulations of nicotine replacement therapy (NRT+), or varenicline (VR). METHODS: A total of 737 smokers, including those with medical and psychiatric comorbidities, were randomly assigned to one of the above three treatment conditions. The NRT group received 10 weeks of patches (21 mg daily maximum); the NRT+ group received patches (35 mg daily maximum) and gum or inhaler for up to 22 weeks; and the VR group received 1 mg twice daily for up to 24 weeks (22 weeks post target quit date). All participants also received six standardized 15-minute smoking cessation counseling sessions by nurses experienced in tobacco dependence treatment. The primary outcome was carbon monoxide-confirmed continuous abstinence rates (CAR) from weeks 5-52. Secondary outcomes were: CAR from weeks 5-10 and 5-22, and carbon monoxide-confirmed 7-day point prevalence (7PP) at weeks 10, 22, and 52. Adjusted and unadjusted logistic regression analyses were conducted using intention-to-treat procedures. RESULTS: The CARs for weeks 5-52 were 10.0 %, 12.4 %, and 15.3 % in the NRT, NRT+, and VR groups, respectively; no group differences were observed. Results with 7PP showed that VR was superior to NRT at week 52 (odds ratio (OR), 1.84; 97.5 % Confidence Interval (CI), 1.04-3.26) in the adjusted intention-to-treat analysis. Those in the VR group had higher CAR at weeks 5-22 (OR, 2.01; CI, 1.20-3.36) than those in the NRT group. Results with 7PP revealed that both NRT+ (OR, 1.72; CI, 1.04-2.85) and VR (OR, 1.96; CI, 1.20-3.23) were more effective than NRT at 22 weeks. As compared to NRT monotherapy, NRT+ and VR produced significant increases in CAR for weeks 5-10 (OR, 1.52; CI, 1.00-2.30 and OR, 1.58; CI, 1.04-2.39, respectively); results were similar, but somewhat stronger, when 7PP was used at 10 weeks (OR, 1.57; CI, 1.03-2.41 and OR, 1.79; CI, 1.17-2.73, respectively). All medications were well tolerated, but participants in the VR group experienced more fatigue, digestive symptoms (e.g., nausea, diarrhea), and sleep-related concerns (e.g., abnormal dreams, insomnia), but less dermatologic symptoms than those in the NRT or NRT+ groups. The frequency of serious adverse events did not differ between groups. CONCLUSIONS: Flexible and combination NRT and varenicline enhance success in the early phases of quitting. Varenicline improves abstinence in the medium term; however, there is no clear evidence that either varenicline or flexible, dual-form NRT increase quit rates in the long-term when compared to NRT monotherapy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01623505 ; Retrospectively registered on July 13, 2011.

The Quit Experience and Concerns of Smokers With Psychiatric Illness.

INTRODUCTION: The purpose of this study is to better understand the quit experience and concerns of smokers with psychiatric illness (i.e., major depressive, anxiety, psychotic and bipolar disorders) in comparison with those without psychiatric illness. METHODS: Smokers (N=732) with (n=430, 59%) and without psychiatric illness, recruited between June 2010 and March 2013 to participate in the FLEX (Flexible and Extended Dosing of Nicotine Replacement Therapy [NRT] and Varenicline in Comparison to Fixed-Dose NRT for Smoking Cessation) smoking-cessation trial, completed questionnaires assessing previously used cessation aids and reasons for relapse, and motivation and concerns about their upcoming quit attempt. These supplementary data analyses were conducted in May 2015. RESULTS: The most commonly used cessation methods during previous attempts were nicotine replacement therapy (66.4%), cold turkey (59.7%), and bupropion (34.7%); no group differences were identified. Stress was the most common precipitator of relapse during previous attempts in all groups (43.6%), particularly among participants with depression and anxiety. Health was the most common motivation for the upcoming quit attempt (91%), followed by family/social pressures (28.1%) and cost (27.9%, particularly by smokers with psychotic disorders). Common pre-cessation concerns for the complete sample included: cravings (27.6%), stress (26.7%), and fear of failure (26%); participants with psychotic and anxiety disorders were most concerned about cravings, whereas the latter two concerns were more prominent for individuals with anxiety. CONCLUSIONS: Findings reveal differences in the quit histories and concerns of smokers with or without psychiatric illness. Smokers with psychiatric illness are particularly vulnerable to relapse at times of stress and negative affect; interventions that emphasize alternative coping strategies and facilitate mood management are required.

Assessing the longitudinal associations and stability of smoking and depression syndrome over a 4-year period in a community sample with type 2 diabetes 24.

BACKGROUND: The aim of the present study was to investigate the stability and longitudinal association between depression and smoking status within a community sample with type 2 diabetes (T2D) while controlling for sociodemographic and disease-related variables. METHODS: Adults with T2D were recruited and agreed to be followed-up via random digit dialing for the Montreal Diabetes Health Study. At baseline, 1614 individuals were classified as never (n = 592), former (n = 690), light (≤10 cigarettes a day; n = 128) and moderate-heavy (11+ cigarettes a day; n = 204) smokers. Depression was assessed using the Patient Health Questionnaire-9 and individuals were classified as either "none" or having depression syndrome. Generalized estimating equations were used to test the association between depression syndrome and current smoking status while controlling for other demographic and health-related variables. RESULTS: Prevalence rates of smoking and depression showed mild to substantial agreement over time. Depression syndrome was significantly associated with moderate-heavy smoking in the fully adjusted model using cross-sectional (all four waves; odds ratio [OR] 1.46; 95% confidence interval [CI] 1.08-1.99; P < 0.05) and longitudinal (controlling for depression at baseline; OR 1.54; 95% CI 1.02-2.31; P < 0.05) data. CONCLUSIONS: Smoking and depression prevalence rates appear to be stable over time in our community sample with T2D. Moderate-heavy smoking is strongly associated with elevated depression, both in cross-sectional and longitudinal models. Persistent moderate-heavy smokers may be at increased risk of both physical and mental health complications. This burden is even greater for those with T2D.

Flexible and extended dosing of nicotine replacement therapy or varenicline in comparison to fixed dose nicotine replacement therapy for smoking cessation: rationale, methods and participant characteristics of the FLEX trial.

Quitting smoking is the single most effective strategy to reduce morbidity and premature mortality in smokers. Research has demonstrated the effectiveness of pharmacotherapy in smoking cessation, but few studies have directly compared varenicline and monotherapy nicotine replacement therapy (NRT) and none have examined varenicline and combinations of NRT products. The majority of smoking cessation trials involve carefully circumscribed populations, making their results less generalizable to those with severe medical conditions or psychiatric comorbidities. This paper reports on the rationale, methodology and participant characteristics of a randomized controlled trial designed to: (1) determine which pharmacotherapy - NRT, long term combinations of NRT, or varenicline - is most effective in achieving abstinence; (2) investigate the incidence of neuropsychiatric symptoms among participants over the course of their quit attempt; and (3) assess whether there is a significant difference in the incidence of neuropsychiatric symptoms in those receiving differing pharmacotherapies, and between those with and without psychiatric illnesses. The primary outcome was carbon monoxide confirmed abstinence from weeks 5-52 following a target quit date. Secondary outcomes included neuropsychiatric (i.e., depression, suicidal ideation, anxiety, anger) and withdrawal symptoms. Smokers (N=737) were randomly assigned to one of three treatment conditions, and were scheduled to attend 8 follow-up appointments over 12 months. All participants received 6-15 minute practical counseling sessions with nurse counselors experienced in treating tobacco dependence. We expect that the results will lead to an enhanced understanding of the efficacy of these pharmacotherapies, including those with a history of psychiatric illness.

Recurrent subthreshold depression in type 2 diabetes: an important risk factor for poor health outcomes.

OBJECTIVE To evaluate the association between recurrent subthreshold depressive episodes and functioning in a prospective community sample of people with type 2 diabetes. RESEARCH DESIGN AND METHODS A prospective community study in Quebec, Canada, was carried out between 2008 and 2013 (n = 1,064). Five yearly follow-up assessments (telephone interviews) were conducted. Baseline and the first three follow-up assessments were used to identify recurrent subthreshold depressive episodes (Patient Health Questionnaire [PHQ]-9). Functioning (World Health Organization Disability Assessment Schedule II [WHODAS-II]) and health-related quality of life (Centers for Disease Control and Prevention [CDC] unhealthy days) at 4- and 5-year follow-up assessments were the outcome measures. RESULTS Nearly half of the participants suffered from at least one episode of subthreshold depressive symptoms. After adjusting for potentially confounding factors, the risk of poor functioning/impaired health-related quality of life was nearly three times higher (relative risk = 2.86) for participants with four subthreshold depressive episodes compared with participants with no/minimal depression. Results suggest a dose-response relationship: the risk of poor functioning/impaired health-related quality of life increased with the number of recurrent subthreshold depressive episodes even after controlling for potentially confounding variables (significant linear trend, P < 0.001). CONCLUSIONS Recurrent subthreshold depressive symptoms might be an important risk factor for poor health outcomes in type 2 diabetes. Early identification, monitoring, and treatment of recurrent subthreshold depressive symptoms might improve functioning and quality of life in people with type 2 diabetes.

The association between smoking and depression in a Canadian community-based sample with type 2 diabetes.

OBJECTIVE: To investigate the association between depression and smoking status within a community-based sample with type 2 diabetes mellitus, while controlling for socio-demographic, diabetes-related characteristics and complications, disability, other chronic illness and other health-related variables. METHOD: A total of 1868 adults with type 2 diabetes were recruited via random digit dialing for the Montreal Health and Well Being Study (DHS). Smoking was classified as never, former, light (≤10 cigarettes a day) and moderate/heavy (11+ cigarettes a day). Depression was assessed using the Patient Health Questionnaire-9 and individuals were classified as no major depression vs. major depression syndrome. Logistic regression was used to test the association between major depression and smoking status, while controlling for other demographic and health-related variables. RESULTS: Major depression was associated with an increased likelihood of being a light or moderate/heavy smoker, having 2 or more diabetes complications, moderate-severe disability, and having 2 or more other chronic illnesses. In the fully adjusted model, having major dpression was associated with an increased likelihood of being a moderate/heavy smoker (odds ratio = 2.62, 95% confidence interval = 1.43-4.81). The association between light smoking and major depression was not significant when adjusting for confounding variables. CONCLUSIONS: Smoking and depression are strongly associated in patients with type 2 diabetes, and this association appears to be strongest for moderate/heavy smokers. This finding has important clinical implications given that smoking cessation is an important health recommendation, and potentially means depression status may be an important consideration when targeting clients with diabetes who continue to smoke.

Exploring the association of psychological status with self-rated diabetes control: results from the Montreal evaluation of diabetes treatment study.

AIMS: There is an increasing interest in single-item self-rated indicators of perceived health and control status in people with chronic illnesses such as diabetes. However, self-rated measures can be associated with indicators of psychological status. The aim of this paper is to explore the association of anxiety, depression, and diabetes distress with self-rated diabetes control. METHODS: Telephone interviews were conducted with 1,787 people with type 2 diabetes taking oral hypoglycemic medication. Diabetes control, health behaviors, and outcomes, anxiety, depression, and diabetes distress were assessed by standardized questionnaires. Self-reported diabetes control was modeled using logistic regression. RESULTS: The best fit logistic regression model for self-rated poor diabetes control was a model that incorporated diabetes distress. When adjusted for age, sex, and all other health behaviors and outcomes, poor diabetes control was most associated with diabetes distress, physical inactivity, being overweight, and poor eating habits. CONCLUSIONS: Results from this study indicate that poor self-rated diabetes control shares the strongest associations with diabetes-specific distress along with perceptions of diabetes-specific healthcare behaviors and outcomes.

Association of diabetes with anxiety: a systematic review and meta-analysis.

OBJECTIVES: Anxiety has been shown to be associated with poor outcomes in people with diabetes. However, there has been little research which has specifically examined whether diabetes mellitus is associated with an increased likelihood of co-morbid anxiety. The aim of this systematic review and meta-analysis was to determine whether people with diabetes are more likely to have anxiety disorders or elevated anxiety symptoms than people who do not have diabetes. METHODS: A systematic review was performed by three independent reviewers who searched for articles that examined the association between anxiety and diabetes in adults 16 or older. Those studies that met eligibility criteria were put forward for meta-analysis using a random-effects model. RESULTS: A total of twelve studies with data for 12,626 people with diabetes were eligible for inclusion in the systematic review and meta-analysis. Significant and positive associations were found for diabetes with both anxiety disorders, 1.20 (1.10-1.31), and elevated anxiety symptoms, 1.48 (1.02-1.93). The pooled OR for all studies that assessed anxiety was 1.25 (1.10-1.39). CONCLUSIONS: Results from this meta-analysis provide support that diabetes is associated with an increased likelihood of having anxiety disorders and elevated anxiety symptoms.

Once daily enoxaparin for outpatient treatment of acute venous thromboembolism: a case-control study.

We studied the efficacy and safety of an investigational enoxaparin regimen, 1.5 mg/kg once daily, as a bridge to warfarin for the outpatient treatment of acute venous thromboembolism. We undertook a case-control design. We enrolled 40 acute venous thromboembolism cases prospectively and matched them by age, gender, and location of venous thromboembolism to 80 previously treated controls. All controls had received enoxaparin 1 mg/kg twice daily. The primary end point was recurrent venous thromboembolism. We followed the cases for 30 days. We discontinued enoxaparin after we achieved the target international normalized ratio between 2.0 and 3.0. One case (2.9%) and three controls (3.8%) had recurrent venous thromboembolic events (P = 1.00). There were no major bleeding complications in the case group, compared to 3 (3.8%) in the control group (P = .55). Once daily enoxaparin, 1.5 mg/kg, as a bridge to warfarin was as effective with a similar safety profile as twice daily enoxaparin, 1mg/kg, for initial treatment of acute venous thromboembolism in the outpatient setting. This case-control study provides the rationale for undertaking a randomized controlled trial comparing enoxaparin 1.5 mg/kg once daily versus enoxaparin 1.0 mg/kg twice daily as a bridge to warfarin in outpatients with acute venous thromboembolism.