In the Journals

Customized adherence enhancement improves adherence, functioning in bipolar disorder

Although both customized adherence enhancement and a bipolar disorder-specific educational program were linked to improved outcomes in patients with bipolar disorder, customized adherence enhancement also resulted in improved adherence, functioning and mental health resource use, according to study findings.

“To improve adherence in [bipolar disorder], it is critical to address adherence barriers, which stem from a variety of factors, including incomplete understanding of the role of medications in recovery, medication side effects, and use of substances that impede adherence with prescribed treatments,” Martha Sajatovic, MD, director of the Neurological and Behavioral Outcomes Center, University Hospitals Cleveland Medical Center, and colleagues wrote. “Treatment approaches should be patient-focused and take into account individual reasons for nonadherence.”

In this 6-month, randomized controlled trial, researchers compared customized adherence enhancement — a brief, disorder-specific approach that targets individual adherence barriers — and a rigorous bipolar disorder-specific educational program to determine changes in adherence, symptoms and functional outcomes in patients with bipolar disorder with poor adherence. In total, 92 participants were randomized to receive customized adherence enhancement and 92 to receive the educational program. The investigators assessed participants at screening, baseline, 10 weeks, 14 weeks and 6 months.

Customized adherence enhancement encompassed up to four treatment modules: psychoeducation focused on medication, modified motivational enhancement therapy, communication with providers and routines that help incorporate medication into daily life. Customized adherence enhancement participants received in-person, individual core sessions spaced 1 week apart over a 4- to 6-week period, one “booster” session 4 weeks after and one follow-up phone call between the sessions. The bipolar disorder-specific educational program had five in-person sessions using the patient workbook from the Systematic Treatment Enhancement Program for Bipolar Disorder study.

Treatment adherence was poor at screening, the results showed. On average, participants (68.5% female; 63% African American) missed about 55% of prescribed bipolar disorder medication assessed at screening within the past week and about 48% in the past month.

Both customized adherence enhancement and the bipolar disorder-specific educational program were well-attended overall. At 6 months, individuals in customized adherence enhancement had improved past-week (P = .001) and past-month (P = .048) adherence scores measured by the Tablets Routine Questionnaire compared with those in the educational program. Further, past-week score improvement remained significant after adjusting for numerous comparisons.

Although both interventions were linked to improved symptoms, there were no treatment arm differences in bipolar disorder symptoms measured via the Brief Psychiatric Rating Scale or other symptoms. Sajatovic and colleagues noted that this may be partially due to low symptom baseline values.

From baseline to 6-months, patients receiving customized adherence enhancement had higher Global Assessment of Functioning scores (P = .036) than those receiving an educational program. Compared with baseline, both groups used more mental health services after 6 months; however, the increase for customized adherence enhancement was less than that for the educational program (P = .046), according to the results.

“[Customized adherence enhancement] appears acceptable to individuals who are often not included in typical research studies (eg, minorities, individuals with poor adherence),” the researchers wrote in the Journal of Clinical Psychiatry. “Studies that investigate how the [customized adherence enhancement] approach might be readily scaled-up and incorporated into typical clinic workflows are needed.” – by Savannah Demko

Disclosures: Sajatovic reports grants from Alkermes, CDC, Janssen, Merck, NIH, Pfizer, Reinberger Foundation, Reuter Foundation and Woodruff Foundation. She also reports consulting for Bracket, Health Analytics, Neurocrine, Otsuka, Sunovion and Supernus, as well as receiving royalties from Johns Hopkins University Press, Oxford Press, Springer Press, and UpToDate. Please see the study for all other authors’ relevant financial disclosures.

Although both customized adherence enhancement and a bipolar disorder-specific educational program were linked to improved outcomes in patients with bipolar disorder, customized adherence enhancement also resulted in improved adherence, functioning and mental health resource use, according to study findings.

“To improve adherence in [bipolar disorder], it is critical to address adherence barriers, which stem from a variety of factors, including incomplete understanding of the role of medications in recovery, medication side effects, and use of substances that impede adherence with prescribed treatments,” Martha Sajatovic, MD, director of the Neurological and Behavioral Outcomes Center, University Hospitals Cleveland Medical Center, and colleagues wrote. “Treatment approaches should be patient-focused and take into account individual reasons for nonadherence.”

In this 6-month, randomized controlled trial, researchers compared customized adherence enhancement — a brief, disorder-specific approach that targets individual adherence barriers — and a rigorous bipolar disorder-specific educational program to determine changes in adherence, symptoms and functional outcomes in patients with bipolar disorder with poor adherence. In total, 92 participants were randomized to receive customized adherence enhancement and 92 to receive the educational program. The investigators assessed participants at screening, baseline, 10 weeks, 14 weeks and 6 months.

Customized adherence enhancement encompassed up to four treatment modules: psychoeducation focused on medication, modified motivational enhancement therapy, communication with providers and routines that help incorporate medication into daily life. Customized adherence enhancement participants received in-person, individual core sessions spaced 1 week apart over a 4- to 6-week period, one “booster” session 4 weeks after and one follow-up phone call between the sessions. The bipolar disorder-specific educational program had five in-person sessions using the patient workbook from the Systematic Treatment Enhancement Program for Bipolar Disorder study.

Treatment adherence was poor at screening, the results showed. On average, participants (68.5% female; 63% African American) missed about 55% of prescribed bipolar disorder medication assessed at screening within the past week and about 48% in the past month.

Both customized adherence enhancement and the bipolar disorder-specific educational program were well-attended overall. At 6 months, individuals in customized adherence enhancement had improved past-week (P = .001) and past-month (P = .048) adherence scores measured by the Tablets Routine Questionnaire compared with those in the educational program. Further, past-week score improvement remained significant after adjusting for numerous comparisons.

Although both interventions were linked to improved symptoms, there were no treatment arm differences in bipolar disorder symptoms measured via the Brief Psychiatric Rating Scale or other symptoms. Sajatovic and colleagues noted that this may be partially due to low symptom baseline values.

From baseline to 6-months, patients receiving customized adherence enhancement had higher Global Assessment of Functioning scores (P = .036) than those receiving an educational program. Compared with baseline, both groups used more mental health services after 6 months; however, the increase for customized adherence enhancement was less than that for the educational program (P = .046), according to the results.

“[Customized adherence enhancement] appears acceptable to individuals who are often not included in typical research studies (eg, minorities, individuals with poor adherence),” the researchers wrote in the Journal of Clinical Psychiatry. “Studies that investigate how the [customized adherence enhancement] approach might be readily scaled-up and incorporated into typical clinic workflows are needed.” – by Savannah Demko

Disclosures: Sajatovic reports grants from Alkermes, CDC, Janssen, Merck, NIH, Pfizer, Reinberger Foundation, Reuter Foundation and Woodruff Foundation. She also reports consulting for Bracket, Health Analytics, Neurocrine, Otsuka, Sunovion and Supernus, as well as receiving royalties from Johns Hopkins University Press, Oxford Press, Springer Press, and UpToDate. Please see the study for all other authors’ relevant financial disclosures.