A Brief Behavioral Intervention Targeting Mental Health Risk Factors for Vascular Disease: A Pilot Study

Psychological distress, often manifesting as depression and anxiety, is a risk factor for vascular disease [1]. These states also contribute to withdrawal and avoidance behaviors, which impede the promotion of health [2]. Effective treatments that target these syndromes and related health behaviors are needed for this broad group of distressed patients at risk of vascular disease, who comprise a considerable proportion of clinic visits [3]. Acceptance and commitment therapy (ACT) is an empirically supported behavioral therapy that aims to enhance psychological flexibility through the use of acceptance, mindfulness and behavioral change strategies. When presented as a brief intervention, ACT has produced positive long-term outcomes in those with comorbidity [4,5]. We developed a 1-day ACT plus education (ACT-IM) group workshop and compared it to a treatment as usual (TAU) group for individuals at risk of vascular disease with clinically significant anxiety or symptoms of depression. We hypothesized that this 1-day intervention would improve quality of life (QOL), depression and anxiety over 6 months. Individuals aged 18-75 years, at risk of vascular disease (i.e. with hypertension, diabetes mellitus or impaired fasting glucose, dyslipidemia or obesity), were screened as outlined in the CONSORT diagram (fig. 1). Of 827 individuals screened, 142 scored >10 on either the Patient Health Questionnaire-8 or the GAD-7. Exclusion criteria were (1) brain injury, (2) medication changes within the past month, (3) schizophrenia or bipolar disorder, (4) current substance abuse and (5) active suicidal ideation. Of those included for this IRB-approved study at the University of Iowa, 30 were randomly assigned (2:1) to ACT-IM and 14 to TAU. As a general measure of well-being, our a priori primary outcome was QOL as measured with the World Health Organization QOL-BREF (WHOQOL-BREF) [6]. Our a priori secondary outcomes included the clinician-rated Hamilton Rating Scale for Depression (HRSD) and Hamilton Rating Scale for Anxiety (HRSA). We also explored self-report measures with the relevant Inventory of Depression and Anxiety Symptoms (IDAS) subscales [7]. An 11-item subscale of the Experiencing Questionnaire (EQ) measured psychological flexibility/decentering [8]. Each 6-hour ACT-IM workshop involved 7-10 participants and emphasized three topics: education (cardiovascular risk factors, diet and lifestyle recommendations and self-monitoring), acceptance (new ways of managing troubling thoughts, feelings and sensations) and behavioral change (how to recognize ineffective patterns, set goals and commit to action). The intervention was manualized and participants received a corresponding workbook. The TAU group received any treatment in the community rather than through the protocol. Linear mixed models for a treatment-by-time interaction assessed the effect of treatment on primary and secondary outcomes for all randomized participants (intention-to-treat). The fixed effects were treatment status (ACT-IM vs. TAU) and time (at baseline, at 12 and at 24 weeks). In analogous models, psychological flexibility (EQ) was assessed as a potential mediator on HRSD. Twenty-six participants completed the ACT-IM intervention and 14 completed TAU. The mean age in both groups was 45 years. A majority of the participants were female (69% ACT-IM, 64% TAU), Caucasian (69% ACT-IM, 86% TAU), had completed college (69% ACT-IM, 71% TAU) and were working (85% ACT-IM, 71% TAU). Nearly half of those assigned to ACT-IM and 64% of those in the TAU condition were on antidepressant medications at study entry. There were no significant differences between the ACT-IM and TAU groups on any baseline variables. In the ACT-IM group, all four WHOQOL-BREF (physical, social, psychological and environment) domains changed significantly from baseline until the follow-up at 24 weeks, but this applied only to the psychological domain in the TAU group. The treatment-by-time interactions were not significant (physical: p = 0.17, psychological: p = 0.67, social: p = 0.18 and environment: p = 0.33). A significant overall group-by-time interaction on HRSD was observed (p < 0.0001, fig. 2a). The mean decrease in HRSD in the ACT-IM condition was 7.1 (95% CI -12.1 to -2.2) greater than in the TAU condition at 12 weeks and 10.8 (95% CI -15.9 to -5.7; effect size = 1.4) greater at 24 weeks. More participants treated with ACT-IM responded (≥50% HRSD reduction) at the 24-week follow-up (ACT-IM: 20/26 or 77%, TAU: 3/14 or 21%, χ2 = 11.5, d.f. = 1, p < 0.01). The self-report IDAS General Depression scale similarly revealed a significant group-by-time interaction (p = 0.0005; effect size = 0.9 at 24 weeks). The HRSA also demonstrated a significant group-by-time interaction (p < 0.0001) (fig. 2b). The mean decrease in HRSA in the ACT-IM condition was 9.4 (95% CI -14.9 to -3.8) greater than in the TAU condition at 12 weeks and 12.7 (95% CI -18.5 to -6.9; effect size = 1.5) greater at 24 weeks. More participants treated with ACT-IM responded to treatment at 24 weeks (ACT-IM: 17/26 or 65%, TAU: 1/14 or 7%, χ2 = 12.5, p < 0.01). The self-reported IDAS Social Anxiety scale had a corresponding group-by-time interaction (p = 0.049).The intervention yielded significant improvements in the hypothesized mediator, psychological flexibility, as measured by the EQ (p = 0.03). Improvements in EQ predicted improvements in HRSD (p < 0.0001, and, after controlling for changes in EQ, the group-by-time interaction on HRSD remained significant even though the standardized parameter estimate was attenuated [-1.14 (p = 0.0005) to -0.87 (p = 0.002)], while a significant relationship with improvements in EQ persisted (p = 0.0002). In this pilot study, we found significant improvements in WHOQOL-BREF in the intervention group, which did not significantly differ from the TAU group. The ACT intervention yielded larger effects on both secondary outcomes, HRSD and HRSA, suggesting that this brief, 1-day intervention may indeed be effective in treating psychological distress in this broad at-risk population with durable effects. A 1-day workshop is a feasible and acceptable alternative to weekly treatments. This brief intervention was designed for ease of implementation in primary care settings, accessibility and cost-effectiveness. The effects of the intervention qualitatively improved at each follow-up visit akin to other ACT treatment trials [5,9]. Participants are taught new ways to approach their thoughts and emotions and to engage more meaningfully in their lives. As they practise these skills, they may develop more flexible patterns of behavior which positively impact well-being. Consistent with this, improvements in psychological flexibility partially mediated the benefits of our intervention on depression. The substantial improvements in depression and anxiety did not translate efficiently to those measured by the WHOQOL-BREF, which incorporates facets less amenable to intervention (e.g. mobility, work capacity, physical environment, financial resources and access to health care and transportation).There is a striking paucity of clinical studies addressing psychological distress with comorbid vascular risk factors. Our small sample limited our ability to detect effects on outcome, which were observed for anxiety and depression. Evaluators of our secondary outcomes were not blind to treatment assignment; however, self-report measures showed similarly positive results. Social desirability and effort justification bias could have differentially impacted the treatment group. The strengths of the study include the random assignment, a high participation rate and a high retention rate. After randomization, more TAU participants were taking antidepressants, which might bias findings opposite to the direction observed. Our generalizable sample included individuals with various vascular risk factors and manifestations of psychological distress as might be commonly encountered in primary care settings. The promise of our preliminary findings for a novel intervention, which could be feasibly disseminated to a neglected at-risk group for vascular disease, warrants replication in a larger clinical trial.This work was made possible by grants (No. KL2RR024980 and UL1RR024979) to the first author from the National Center for Research Resources (NCRR), a part of the National Institutes of Health (NIH) and a grant (No. 1K23MH083695-01A210) to the last/senior author from the NIH. Funding was also provided by the Department of Psychiatry at the University of Iowa. The authors declare that there are no conflicts of interest in this study. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NCRR or NIH.