Effects of an Integrative Psychological Program in Bipolar Disorder
Effects of an Integrative Psychological Program in Bipolar Disorder
Bipolar disorder is related to a high level of personal, familial, social and economic
 burden. There is a need for feasible adjunctive psychological interventions to use in
 clinical practice as a complement of pharmacotherapy to enhance aspects that medication
 cannot reach. This project aims at develop and evaluate the impact of an adjunctive brief
 integrative program for bipolar patients (euthymic or with subthreshold symptoms). The
 patients (N=124) will be randomly assigned to two different groups. The experimental group
 (62 patients) will take part on a group integrative program consisting of 12-sessions of 90
 minutes (based on psychoeducation, mindfulness and functional remediation) whilst the control
 group (62 patients) will not receive any sort of add-on psychotherapy. All patients will
 mantain standard psychiatric treatment. Together with the baseline assessment, the whole
 sample will be assessed after the intervention and at 12 months from the baseline evaluation,
 regarding sociodemographic, clinical and neuropsychological variables. If the intervention is
 effective it will improve psychosocial functioning (main variable), wellbeing and quality of
 life, as well as improve clinical outcomes and neurocognitive functioning of those affected
 by the illness.
Study design: Single-blind randomized control trial.

 Participants: Study participants will be enrolled from the Bipolar Disorders Program of the
 Hospital Clinic of Barcelona (Spain) and the Bipolar Disorders Unit.

 Procedure: At baseline, the sample will be evaluated with respect to sociodemographic,
 clinical and neuropsychological variables. Subsequently, patients will be randomly assigned
 (1:1) to two different groups. The experimental group (62 patients) will take part on the
 integrative group program consisting of 12-sessions, 90 minutes each, once a week (4 focused
 on psychoeducation, 1 directed to the family relatives, 3 on mindfulness and 4 on functional
 remediation) whilst the control group (62 patients) will not receive any type of add-on
 psychotherapy. All the patients will maintain a standard psychiatric treatment during the
 study. Together with the baseline assessment, the whole sample will be assessed after the
 intervention and at the 12 months of follow-up. Psychiatric medication will be recorded
 during the follow-up and the reasons for eventual modifications. All the subjects will be
 evaluated by researchers blinded to the treatment condition. Semi-structured interviews will
 be conducted and complemented with clinical records and with assessment instruments to
 collect variables related to the course of the illness. This study will be conducted in
 accordance with the ethical principles of the Declaration of Helsinki and Good Clinical
 Practice and approved by the Hospital Clinic Ethics and Research. All participants will be
 asked to provide written informed consent prior to their inclusion in the study.

 Variables assessed:

 1. Demographic variables: gender, age, marital status, educational status and work
 situation.

 2. Clinical variables: age at the onset of BD, age at first hospitalization, total number
 and type of previous episodes, hospitalizations, history of psychotic symptoms, polarity
 of the first episode, seasonal pattern, presence of rapid cycling, bipolar subtype (I or
 II), comorbidities, familial psychiatric history, familial history of affective
 disorder, familial history of complete suicide, previous suicide attempts, number of
 attempts, method and medical severity of attempts, history of drug use.

 3. Clinical scales: Temperament Evaluation of the Memphis, Pisa, Paris, and San Diego
 Autoquestionnaire (TEMPS-A, Akiskal et al, 2005), Barratts Impulsiveness Scale (BIS-11,
 Barratt et al, 1983), Biological Rhythms Interview of Assessment in Neuropsychiatry
 (BRIAN, Rosa et al., 2007), and Cognitive Complaints in Bipolar Disorder Rating
 Assessment (COBRA, Rosa et al., 2013).

 4. Psychosocial functioning: Functional assessment short test (FAST, Rosa et al., 2007).

 5. Wellbeing and quality of life: WHO (Five) Well Being Index (WHO, 1998), Quality of Life
 in Bipolar Disorder scale (QoL.BD, Michalak y Murray, 2010).

 6. Scales of mindfulness: Five Facet Mindfulness Questionnaire (FFMQ, Baer et al., 2006),
 Mindful Attention Awareness Scale (MAAS, Brown y Ryan, 2003).

 7. Neuropsychological assessment: WAIS-IV (Wechsler, 2012), with the following subtests:
 vocabulary, arithmetic, digit span, letter-number sequencing, symbol search, coding;
 Wisconsin Card Sorting Test (WCST, Heaton et al, 1981); Stroop Color-Word Interference
 Test (Golden y col., 1995); F-A-S Verbal Phonemic Fluency Test (Benton & Hamser, 1978);
 Trail Making Test (TMT, Reitan y Wolfson, 1985); Continuous Performance Test (CPT-III,
 Conners 2014); California Verbal Learning Test (CVLT-II, Delis et al, 2000);
 Rey-Osterrieth Complex Figure Test (Osterreith, 1944; Rey, 1941); the Mayer-
 Salovey-Caruso Emotional Intelligence Test (MSCEIT, Mayer et al., 2003) and the Iowa
 Gambling Test (IGT, Bechara et al, 1994).
Inclusion Criteria:

 -  diagnosis of BD type I or II according to DSM-5 criteria

 -  euthymic or with subthreshold symptoms (HDRS <14; YMRS <8)

 -  absence of an acute mood episode in the 3 months prior to the beginning of the
 intervention

 Exclusion Criteria:

 -  estimated Intelligence Quotient (IQ) lower than 85,

 -  significant physical or neurologic illness that can affect neuropsychological
 performance

 -  DSM-5 criteria of substance abuse or dependence

 -  inability to understand the purposes of the study

 -  absence of psychosocial interventions in the past 2 years (psychoeducation group,
 functional remediation, mindfulness)