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 health promotion [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 portion of clinic visits [3]. Acceptance and Commitment Therapy (ACT) is an empirically-supported behavioral therapy that aims to enhance psychological flexibility through use of acceptance, mindfulness, and behavioral change strategies. When presented as a brief intervention, ACT has produced positive long-term outcomes in those with co-morbidity [4, 5]. We developed a one-day ACT plus education (ACT-IM) group workshop and compared it to treatment as usual (TAU) for individuals at risk of vascular disease with clinically significant anxiety or depressive symptoms. We hypothesized this one-day intervention would improve quality of life, depression, and anxiety over six months. Individuals, ages 18–75, at risk of vascular disease (hypertension, diabetes mellitus or impaired fasting glucose, dyslipidemia, or obesity) were screened as outlined in the CONSORT Diagram (Figure 1). Of 142/827 screened scored ≥10 on either the Patient Health Questionnaire-8 or the GAD-7 without exclusion criteria: 1) brain injury; 2) past month medication changes; 3) schizophrenia or bipolar disorder, 4) current substance abuse; and 5) active suicidal ideation. Of those consented for this IRB-approved study at the University of Iowa, 30 were randomly assigned (2:1) to ACT-IM and 14 to TAU. Figure 1 Participant flow chart for the treatment trial. As a general measure of well-being, our a priori primary outcome was Quality of Life as measured with the World Health Organization Quality of Life-BREF (WHOQOL-BREF) [6]. Our a priori secondary outcomes included the clinician-rated Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HRSA). We also explored self-report measures with 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 versus TAU) and time (baseline, 12-, and 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. 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 taking antidepressant medications at intake. There were no significant differences between the ACT-IM and TAU groups on any variables. All four WHOQOL-BREF (physical, social, psychological, environment) domains significantly changed from baseline through the 24-week follow-up with ACT-IM, but only for the psychological domain with TAU. The treatment-by-time interactions were not significant (Physical p=0.17; Psychological p=0.67; Social p =0.18; Environmental p=0.33). A significant overall group-by-time interaction on HRSD was observed (p