Randomized controlled trial of an intervention to prevent adherence failure among HIV-infected patients initiating antiretroviral therapy.

OBJECTIVE: Compare the efficacy of a multicomponent social support intervention to standard-of-care counseling on medication adherence among HIV-infected patients initiating antiretroviral therapy. DESIGN: Randomized controlled trial. Generalized estimating equations tested for differences in the percentage of participants achieving 90% adherence. MAIN OUTCOME MEASURES: Pill-taking, electronically monitored over 6 consecutive months; plasma viral load (VL), assessed at 3 and 6 months following initiation of therapy. RESULTS: Of 226 participants who were randomized and began the trial, 87 (38%) were lost to the study by 6 months. The proportion of adherent participants declined steadily over time, with no time by group interaction. Sustained adherence was associated with increased odds of achieving an undetectable VL (OR=1.78; 95% CI=1.01, 3.13). In intention-to-treat analyses, a larger proportion of the intervention group than the control group was adherent (40.15% vs. 27.59%, p=.02) and achieved an undetectable VL p=.04). However, the majority of participants who remained on study experienced some reduction in VL (>or=1-log drop or undetectable), regardless of experimental condition. CONCLUSION: The multicomponent social support intervention significantly improved medication adherence over standard-of-care counseling; evidence for improved virologic outcomes was inconsistent. Early discontinuation of care and treatment may be a greater threat to the health of HIV patients than imperfect medication-taking.     

Depression and medication adherence among breast cancer survivors: Bridging the gap with the theory of planned behaviour

Evidence suggests that more depressed breast cancer patients will less likely adhere to treatment plans. This study presents evidence that the theory of planned behaviour mediates the relation between depression and intentions to adhere to treatment plans and between depression and lack of adherence to medication regime. Two hundred and thirteen women undergoing breast cancer treatment participated in this study. Measures of depressive symptoms and planned behaviour variables were collected at the first time point; measures of medication adherence were collected at the second time point. Structural equation models were utilised to fit the data to the proposed models. Depressive symptoms were significantly correlated to both intentions and medication adherence. In support of hypotheses, the relation between depressive symptoms and treatment intention was mediated by attitudes towards health maintenance plans. The relation between depressive symptoms and medication adherence was fully mediated by the planned behaviour process. Conditions under which treatment intentions and perceptions of control in adhering to treatment were most related to medication adherence were elucidated. The results point to avenues for interventions to increase medication adherence among breast cancer patients. Manipulating attitudes and perceptions of control towards treatment plans will potentially serve to increase medication adherence.     

Depression and medication adherence among breast cancer survivors: bridging the gap with the theory of planned behaviour

Evidence suggests that more depressed breast cancer patients will less likely adhere to treatment plans. This study presents evidence that the theory of planned behaviour mediates the relation between depression and intentions to adhere to treatment plans and between depression and lack of adherence to medication regime. Two hundred and thirteen women undergoing breast cancer treatment participated in this study. Measures of depressive symptoms and planned behaviour variables were collected at the first time point; measures of medication adherence were collected at the second time point. Structural equation models were utilised to fit the data to the proposed models. Depressive symptoms were significantly correlated to both intentions and medication adherence. In support of hypotheses, the relation between depressive symptoms and treatment intention was mediated by attitudes towards health maintenance plans. The relation between depressive symptoms and medication adherence was fully mediated by the planned behaviour process. Conditions under which treatment intentions and perceptions of control in adhering to treatment were most related to medication adherence were elucidated. The results point to avenues for interventions to increase medication adherence among breast cancer patients. Manipulating attitudes and perceptions of control towards treatment plans will potentially serve to increase medication adherence.     

Improving adherence to physical activity

Two studies tested the efficacy of Marlatt and Gordon's relapse-prevention approach in increasing attendance during an exercise program (short-term adherence) and continuation of exercise activities for 12 weeks following termination of the formal program (longer term adherence). Participants in both studies were registrants in 10-week exercise groups (jogging, aerobic dance, and pre-ski training) sponsored by the Université de Montréal Sports Centre. The intervention, designed to increase awareness of obstacles to exercise and to develop appropriate techniques for coping with them, was delivered by group leaders within the context of the regular program. Results of both studies indicate a small but consistent superiority of adherence in the experimental condition compared to the control condition. The low cost of this intervention, however, makes even small gains cost effective. Possible methods for strengthening the treatment effect are discussed.     

Electronic monitoring and counseling to improve medication adherence

Electronic caps, pill caps that record the date and time of pill bottle opening provide an objective measure of adherence to prescribed medication. A promising intervention to improve adherence, cue-dose training, involves reviewing patients' pill cap-generated reports concerning their medication-taking and offering individualized recommendations for remembering to take medications at specific times of day. In this preliminary study, 79 patients prescribed the antihyperglycemic medication metformin had adherence assessed during a 4-week baseline period. Adherence, defined as proportion of prescribed doses taken within a predetermined 4-h window, was measured using electronic MEMS caps. Those who had less than 80% baseline adherence (n = 33) were randomly assigned to either receive 4 months of cue-dose training (n = 16) or to a control group (n = 17). Cue-dose training was associated with significantly better adherence to metformin (mean improvement of 15%). The effects of cue-dose training on adherence to other antihyperglycemic medication did not reach statistical significance. Glycosylated hemoglobin (a measure of blood sugar control) did not differ between groups. Data from nine patients who reviewed pill cap-generated data with their primary care providers suggested that both patients and providers found the discussion moderately helpful and not at all uncomfortable.     

CBT for Medication Adherence and Depression (CBT-AD) in HIV-Infected Patients Receiving Methadone Maintenance Therapy

For individuals with HIV who are current or former injection drug users, depression is a common, distressing condition that can interfere with a critical self-care behavior—adherence to antiretroviral therapy. The present study describes the feasibility and outcome, in a case series approach, of cognitive behavioral therapy to improve adherence and depression (CBT-AD) among individuals with HIV and depression undergoing methadone maintenance treatment for heroin dependence. CBT-AD integrates cognitive behavioral therapy for depression with our intervention for improving adherence to antiretroviral therapy for HIV (Life-Steps; [Safren, S. A., Otto, M. W., Worth, J., Salomon, E., Johnson, W., Mayer, K., et al. (2001). Two strategies to increase adherence to HIV antiretroviral medication: Life-Steps and medication monitoring. Behavioral Research and Therapy, 39, 1151–1162]). Specifically, in CBT-AD, patients first receive a cognitive behavioral intervention focusing on improving skills related to medication adherence. Each of the subsequent CBT modules (activity scheduling, cognitive restructuring, problem-solving training, and relaxation training/diaphragmatic breathing) is designed to address both self-care/adherence behaviors as well as depression. The process and outcome with 4 cases suggest that the treatment was feasible and acceptable and was generally associated with improvements. This case series provides an example of how cognitive behavioral therapists can integrate the treatment of depression with the enhancement of critical self-care behaviors in the context of highly complex, medical and psychiatric comorbidity.     

The Partners for Life Program: A Couples Approach to Cardiac Risk Reduction

Morbidity and mortality are reliably lower for the married compared with the unmarried across a variety of illnesses. What is less well understood is how a couple uses their relationship for recommended lifestyle changes associated with decreased risk for illness. Partners for Life compared a patient and partner approach to behavior change with a patient only approach on such factors as exercise, nutrition, and medication adherence. Ninety‐three patients and their spouses/partners consented to participate (26% of those eligible) and were randomized into either the individual or couples condition. However, only 80 couples, distributed across conditions, contributed data to the analyses, due to missing data and missing data points. For exercise, there was a significant effect of couples treatment on the increase in activity and a significant effect of couples treatment on the acceleration of treatment over time. In addition, there was an interaction between marital satisfaction and treatment condition such that patients who reported higher levels of marital distress in the individuals condition did not maintain their physical activity gains by the end of treatment, while both distressed and nondistressed patients in the couples treatment exhibited accelerating gains throughout treatment. In terms of medication adherence, patients in the couples treatment exhibited virtually no change in medication adherence over time, while patients in the individuals treatment showed a 9% relative decrease across time. There were no condition or time effects for nutritional outcomes. Finally, there was an interaction between baseline marital satisfaction and treatment condition such that patients in the individuals condition who reported lower levels of initial marital satisfaction showed deterioration in marital satisfaction, while non satisfied patients in the couples treatment showed improvement over time.     

Patterns, correlates, and barriers to medication adherence among persons prescribed new treatments for HIV disease.

New treatments for HIV can improve immune functioning and decrease mortality. However, lapses in adherence may render these complex regimens ineffective. Sixty-three men and 9 women on highly active antiretroviral therapy completed measures of medication adherence, psychological characteristics, and barriers to adherence. HIV viral load, a health outcome measure of virus amount present in blood, was also obtained. The sample was 36% African American and 56% Caucasian, with 35% reporting disability. Nearly one third of patients had missed medication doses in the past 5 days, and 18% had missed doses weekly over the past 3 months. Frequency of missed doses was strongly related to detectable HIV viral loads. Depression, side-effect severity, self-efficacy, and social support distinguished patients with good and poor adherence. Barriers also varied with adherence level. Implications for interventions promoting HIV treatment adherence are discussed.     

Medication barriers and anti-hypertensive medication adherence: the moderating role of locus of control

Locus of control as a moderator of the relationship between medication barriers (e.g., side-effects, forgetting to take medication, and keeping track of pills) and anti-hypertensive medication adherence was examined. Baseline data were obtained from 588 hypertensive veterans. In general, fewer medication barriers, higher internal locus of control and lower external locus of control was associated with better hypertensive medication adherence. Furthermore, internal locus of control served as a moderator (beta = -.74, p < .01) for the relationship between medication barriers and medication adherence; effect size was large. Decomposition of the interaction revealed that the relationship between medication barriers and medication adherence was strongest when internal control was high (b = -.24, p < .01). Higher internal locus of control was beneficial when barriers to medication adherence are low, but at high perceived barriers, locus of control plays less of a role in medication adherence. Future efforts to improve medication adherence should consider the patient's perceived level of medication barriers in conjunction with their locus of control.     

Behavioral control of exercise in adults: Studies 7 and 8

Abstract

Building on our previous six study series, the current studies 7 and 8 evaluated behavioral methods of improving adherence to exercise in adults. The studies tested the effectiveness of a single exercise modality versus choice of a variety of exercises and were conducted as part of a 12-week extended studies college course in San Diego, CA. Recruitment efforts were targeted to individuals who reported that they were sedentary and/or had experienced difficulty adhering to regular exercise. Participants were 42 adults (32F, 10M; mean age = 42.0) in Study 7 and 48 adults (35F, 8M; mean age = 47.9) in Study 8. In each study, subjects were randomly assigned to a single focus or variety exercise condition. There were no significant group differences in class attendance or out-of-class exercise adherence rates in Studies 7 or 8. In Study 7, significantly lower drop-out rates were detected in the single focus group (19%) than the variety condition (47.6%) (p = 0.04). No significant group differences were detected for drop-out rates in Study 8. Suggestions for further research are offered.     

The Beliefs About Medication Scale: Development, Reliability, and Validity

The purpose of the study was to develop and evaluate a psychometrically sound health belief measure, the Beliefs About Medication Scale (BAMS) that can be used with adolescent chronic illness populations whose prescribed treatment includes oral medication. One hundred and thirty-three adolescents (age 11–18 years) with asthma (n = 60), HIV (n = 31), or inflammatory bowel disease (n = 42) completed the BAMS and, along with their parent, a self-report medication interview. A confirmatory factor analysis supported the hypothesized subscales of Perceived Threat, Positive Outcome Expectancy, Negative Outcome Expectancy, and Intent to Adhere to treatment. The subscales evidenced good internal consistency and 3-week test-retest reliability. Univariate and multivariate analyses demonstrated that the health belief constructs accounted for 22% of the variance in medication adherence beyond demographic and illness characteristics. The study provides preliminary evidence of the reliability and validity of a theoretically based measure of health beliefs for adolescents. The BAMS may be a useful tool to evaluate the psychological barriers to adherence that place teenagers at risk for nonadherence.     

Adherence to antiretroviral medications in HIV: differences in data collected via self-report and electronic monitoring.

Controversy remains regarding the reliability of methods used to determine adherence to antiretroviral medication in HIV. In this study the authors compared adherence rates of 119 HIV-positive participants during a 6-month study, as estimated via electronic monitoring (EM) and self-report (SR). Adherence for both short (4-day) and long (4-week, or intervisit) periods was examined, as well as factors that underlie discrepancies between EM and SR. Results showed that intervisit EM estimates were consistently lower than those of SR. SR estimates based on shorter periods (4 days) were closer to those of EM. Higher discrepancies between EM and SR estimates were associated with lower cognitive functioning and externalized locus of control. These findings lend support for using both EM and SR methods; however, study design (e.g., length) and other factors (e.g., cognitive status, cost) should be considered.     

Behavioral interventions may prolong remission in patients with inflammatory bowel disease

Inflammatory Bowel Diseases (IBDs) are chronic, relapsing and remitting gastrointestinal conditions with no known cure. Previous studies have linked behavioral factors, including stress and medication adherence, to relapse.

Purpose

We sought to determine the effect of participation in a behavioral self-management program on incidence of flare within 12 months following behavioral intervention when compared to the natural history of flare incidence prior to program participation.

Results

Results from a 2-level regression model indicated that those participants in the treatment group were 57% less likely to flare in the following 12 months (compared to 18% in the control group). The decline in “flare odds” was about 2 times greater in treatment versus controls (OR = 0.52, t(34) = 2.07, p < 0.05). Office visits, ER visits, and disease severity (all p < 0.05) were identified as moderators of flare risk.

Conclusions

We have demonstrated 1) a statistical model estimating the likelihood of flare rates in the 12 months following a behavioral intervention for IBD (compared to a control condition), and 2) that the introduction of a behavioral intervention can alter the natural course of a chronic, relapsing and remitting gastrointestinal condition such as IBD.     

Effect of a behavioral self-regulation intervention on patient adherence in hemodialysis.

The present study examined the efficacy of a behavioral intervention designed to increase adherence to fluid-intake restrictions among hemodialysis patients. Twenty intervention-group patients were compared with 20 matched control patients on an indicator of fluid-intake adherence at 3 time points. The Group x Time interaction was significant, indicating that patients in the 2 groups exhibited a differential pattern of change in fluid-intake adherence across the follow-up period. The intervention and control groups did not differ significantly in terms of adherence at the initial postintervention period but did differ at the 8-week follow-up. The observed group differences were, in part, due to a trend toward increasingly better adherence in the intervention group and poorer adherence in the control group across the follow-up period.     

Internet-based self-help treatment for panic disorder: a randomized controlled trial comparing mandatory versus optional complementary psychological support

Panic disorder (PD) is one of the most common psychiatric disorders. Web-based self-help treatments for PD have had promising results. These online treatments seem to have larger effect sizes (ESs) when professional support is added. However, the amount of support or how it should be administered is not yet clear. The aim of this trial was to study two ways of administering psychological support provided by phone as a part of Internet-based self-help treatment for PD based on cognitive behavioral therapy. Seventy-seven participants diagnosed with PD were randomly assigned to one of three experimental conditions: a waiting list control group; a treatment group with non-scheduled psychological support; or a treatment group with scheduled psychological support. PD symptoms of participants who received treatment improved significantly compared to the control group (mean ES d = 1.18, p < .05). In addition, there were statistically and clinically significant differences between treatment groups (Mean difference = ?3.20, p = .005, 95% CI [?5.62, ?.79]). The scheduled group showed a larger ES, a lower dropout rate, and better adherence to treatment than the non-scheduled group. Scheduled support seems to be indicated for patients who seek Web-based treatment for PD, and their symptoms of panic, anxiety, and depression improve at post-treatment and six-month follow-up. In contrast, when support depends on patient demand, they receive less support and so, the therapeutic effect is poorer.     

Effects of two treatment techniques on delay and vigilance tasks with attention deficit hyperactive disorder (ADHD) children.

In this study, we examined the effects of two treatment techniques under on-medication and off-medication conditions on the hyperactive behavior patterns of children. Three groups of subjects were compared: a control group, a behavior modification group, and a cognitive training group. The Gordon Diagnostic System (Gordon, McClure, & Post, 1986) was used to assess the subjects at the initial screening, during treatment without medication, and during treatment with medication. The two medication conditions were counterbalanced during the second and third testing sessions. Results showed that when the cognitive intervention was combined with medication, there was a significant improvement in the subjects' ability to delay impulsive responding. However, no significant effects were seen for sustained vigilance for either the behavioral or cognitive groups. Parents rated children in the cognitive group significantly higher than those in the control group.     

Two strategies to increase adherence to HIV antiretroviral medication: life-steps and medication monitoring

Advances in the medical treatment of HIV have made it clear that adherence to highly active antiretroviral treatment is a crucial feature for treatment success. The present paper had two goals: (1) to examine psychosocial predictors of adherence in persons receiving HIV antiretroviral therapy; (2) to compared two minimal-treatment interventions to increase HIV medication adherence in a subset of persons who self-reported less than perfect adherence. One of the interventions, Life-Steps, is a single-session intervention utilizing cognitive-behavioral, motivational interviewing, and problem-solving techniques. The other intervention, self-monitoring, utilizes a pill-diary and an adherence questionnaire alone. Significant correlates of adherence included depression, social support, adherence self-efficacy, and punishment beliefs about HIV. Depression was a significant unique predictor of adherence over and above the other variables. Both interventions yielded improvement in adherence from baseline, and the Life-Steps intervention showed faster improvements in adherence for persons with extant adherence problems.     

Age-associated predictors of medication adherence in HIV-positive adults: health beliefs, self-efficacy, and neurocognitive status.

OBJECTIVE: Although most agree that poor adherence to antiretrovirals is a common problem, relatively few factors have been shown to consistently predict treatment failure. In this study, a theoretical framework encompassing demographic characteristics, health beliefs/attitudes, treatment self-efficacy, and neurocognitive status was examined in relationship to highly active antiretroviral therapy adherence. DESIGN: Prospective, cross-sectional observational design. MAIN OUTCOME MEASURES: Neuropsychological test performance, health beliefs and attitudes, and medication adherence tracked over a 1-month period using electronic monitoring technology (Medication Event Monitoring System caps). RESULTS: The rate of poor adherence was twice as high among younger participants than with older participants (68% and 33%, respectively). Results of binary logistic regression revealed that low self-efficacy and lack of perceived treatment utility predicted poor adherence among younger individuals, whereas decreased levels of neurocognitive functioning remained the sole predictor of poor adherence among older participants. CONCLUSION: These data support components of the health beliefs model in predicting medication adherence among younger HIV-positive individuals. However, risk of adherence failure in those ages 50 years and older appears most related to neurocognitive status.     

A randomized controlled trial of a peer support intervention targeting antiretroviral medication adherence and depressive symptomatology in HIV-positive men and women.

OBJECTIVE: To determine the efficacy of a peer-led social support intervention involving support groups and telephone contacts compared with standard clinical care to enhance antiretroviral medication adherence. DESIGN: Randomized controlled trial with follow-up. Participants were 136 HIV-positive indigent mainly African American and Puerto Rican men and women recruited from an outpatient clinic in the Bronx, New York. The 3-month intervention was delivered by other HIV-positive clinic patients trained in addressing barriers to adherence and sensitively providing appraisal, spiritual, emotional, and informational adherence-related social support. MAIN OUTCOME MEASURES: Medical chart-abstracted HIV-1 RNA viral load, antiretroviral adherence according to electronic drug monitoring and participant self-report, and social support and depressive symptomatology. All assessments conducted at baseline, 3 months, and 6 months. RESULTS: Intent-to-treat and as-treated analyses indicated no between-conditions intervention effects on the primary outcome of HIV-1 RNA viral load or any of the secondary outcomes at immediate postintervention or follow-up. Post hoc analyses within the intervention condition indicated greater intervention exposure was associated with higher self-reported adherence, higher social support, and lower depressive symptomatology at follow-up, even after controlling for baseline adherence. CONCLUSION: Null findings, consistent with the limited literature on efficacious highly active antiretroviral therapy (HAART) adherence interventions, may be due to insufficient exposure to the intervention, its low intensity, or the nature of the sample-a heterogeneous HAART-experienced group of patients with high levels of substance use and multiple other competing stressors. Overall, findings highlight the need for more comprehensive and intensive efforts to battle nonadherence.     

Efficacy of written modeling and vicarious reinforcement in increasing use of problem-solving methods by distressed individuals

The authors evaluated an application of social cognitive theory principles intended to increase adherence to a problem-solving intervention. The study included 132 adult volunteers who wanted to reduce their distress levels. All participants received group training in problem-solving methods. Before attempting to solve at least 1 distressing problem in their lives over the next 3 weeks, participants were randomly assigned to either (a) a modeling with vicarious reinforcement condition in which they received 3 personal anecdotes written by individuals who had successfully applied problem-solving methods to a real problem or (b) a control condition in which they received a fact sheet about problem solving. Word counts of problem-solving writing, self-reports of adherence, and observer ratings of adherence showed that participants in the vicarious reinforcement condition demonstrated significantly higher adherence than did those in the control condition. These results provide support for the effectiveness of symbolic modeling and vicarious reinforcement in increasing adherence to problem-solving methods by individuals who want to decrease their distress.