PARIS – A 21-week program of "functional remediation" for 220 adults with bipolar disorder was more effective than psychosocial education or usual treatment in improving psychosocial functioning at 6 months of follow-up.
The multicenter trial randomized euthymic adults with bipolar disorder type I or II at 10 centers in Spain to 21 weeks of treatment in one of three groups: weekly 90-minute group sessions for functional remediation; group psychoeducation sessions, or a control group that got treatment as usual. The functional remediation sessions covered aspects of cognition and psychosocial restoration, Dr. Eduard Vieta said at the annual congress of the European College of Neuropsychopharmacology.
The study measured functional status using the Functional Assessment Short Test (FAST). The FAST provides on objective measure, compared with assessments of quality of life that produce subjective results, said Dr. Vieta, director of the Bipolar Disorders Program at the Clinical Institute of Neuroscience, University of Barcelona. To be eligible for the study, patients had to have FAST scores of 18 or greater, which allowed room to show improvement, and only patients up to age 50 years were accepted in order to avoid cognitive deficits associated with older age.
Previous data using FAST show that patients with bipolar disorder have significantly lower functioning in measures of autonomy, cognition, financial issues, interpersonal functioning, leisure time, and overall scores compared with people without bipolar disorder (Bipolar Disord. 2009;11:401-9). In one study, cognitive function scores on the FAST at baseline predicted functional outcome 4 years later (J. Affect. Disord. 2010;121:156-60).
In the current study, there were no significant differences at baseline in functioning between groups as measured by FAST scores. In the functional remediation group, 30% discontinued treatment during the study compared with 27% in the psychoeducation group and 18% getting treatment as usual.
At 6-month follow-up, FAST scores of functioning were significantly better in the functional remediation group compared with the psychoeducation group or the control group. A preliminary analysis of results suggests that the difference in FAST scores was significant to a P value of .001, reported Dr. Vieta and his associate in the study, Carla Torrent, Ph.D., also with both of the University of Barcelona.
In an assessment of effect size, the functional remediation had a large effect, the psychoeducation had a small effect, and treatment as usual had essentially no effect, he said.
Among the various functional domains, functional remediation had the most impact on cognitive, interpersonal, and autonomy domains, each with a medium effect. Small effects were seen on leisure, financial, and occupational domains.
The functional remediation program addressed cognition and psychosocial restoration using neurocognitive techniques for daily life. It included education about cognitive deficits and their impact on daily life, and sought to increase insight regrading cognitive dysfunctions. The program provided patients with strategies to manage cognitive deficits, primarily in the areas of attention, memory, and executive function. In some cases, the patient’s family participated to help the patient practice the strategies and to reinforce the learning.
The neurocognitive behavioral approach in the program employed modeling techniques, role playing, verbal instructions, self-instructions, positive reinforcement, and metacognitive cues.
Each 90-minute session began with a 15-minute discussion of assigned homework and a 5-minute warm-up task, followed by 20 minutes of theory and cognitive strategies. Practical exercises for the next 45 minutes were followed by 5 minutes to focus on take-home points and tasks to do at home.
The 21 sessions focused on specific topics grouped within categories of education, attention, memory, executive functions, and improving communication, autonomy, and stress management. Sessions 12-16, for example, focused on executive functions, with sessions on self-instructions and self-monitoring of executive functions, programming and organizing activities, establishing priorities and time management, problem-solving techniques, and solving problems.
The investigators have not yet done a cost-benefit analysis, but a functional remediation program should not be too expensive, Dr. Vieta said. "You just need one neuropsychologist" or two to organize and lead the program, he said. Previous cost analyses have shown group psychoeducation to be cost effective. "This should be, too," he said.
Medication can treat acute episodes of bipolar disorder, and help prevent relapse and recurrences. Group psychoeducation is effective in reducing recurrences in euthymic bipolar patients, but it does not tackle cognitive impairment or functioning. Impaired cognition has been associated with nonadherence to therapy.
Previous studies suggest that impaired functioning remains in many patients even after successful treatment for bipolar disorder. In one study, conventional treatment produced syndromal recovery in 85% at 6 months and 98% at 2 years, but functional recovery was seen in only 30% at 6 months and 38% at 2 years (Am. J. Psychiatry 2000;157:220-8).