Early specific cognitive-behavioural psychotherapy in subjects at high risk for bipolar disorders: study protocol for a randomised controlled trial

Abstract

BackgroundBipolar disorders (BD) are among the most severe mental disorders with first clinical signs and symptoms frequently appearing in adolescence and early adulthood. The long latency in clinical diagnosis (and subsequent adequate treatment) adversely affects the course of disease, effectiveness of interventions and health-related quality of life, and increases the economic burden of BD. Despite uncertainties about risk constellations and symptomatology in the early stages of potentially developing BD, many adolescents and young adults seek help, and most of them suffer substantially from symptoms already leading to impairments in psychosocial functioning in school, training, at work and in their social relationships. We aimed to identify subjects at risk of developing BD and investigate the efficacy and safety of early specific cognitive-behavioural psychotherapy (CBT) in this subpopulation.Methods/DesignEarlyCBT is a randomised controlled multi-centre clinical trial to evaluate the efficacy and safety of early specific CBT, including stress management and problem solving strategies, with elements of mindfulness-based therapy (MBT) versus unstructured group meetings for 14 weeks each and follow-up until week 78. Participants are recruited at seven university hospitals throughout Germany, which provide in- and outpatient care (including early recognition centres) for psychiatric patients. Subjects at high risk must be 15 to 30 years old and meet the combination of specified affective symptomatology, reduction of psychosocial functioning, and family history for (schizo)affective disorders. Primary efficacy endpoints are differences in psychosocial functioning and defined affective symptomatology at 14 weeks between groups. Secondary endpoints include the above mentioned endpoints at 7, 24, 52 and 78 weeks and the change within groups compared to baseline; perception of, reaction to and coping with stress; and conversion to full BD.DiscussionTo our knowledge, this is the first study to evaluate early specific CBT in subjects at high risk for BD. Structured diagnostic interviews are used to map the risk status and development of disease. With our study, the level of evidence for the treatment of those young patients will be significantly raised.Trial registrationWHO International Clinical Trials Platform (ICTRP), identifier: DRKS00000444, date of registration: 16 June 2010.

Ethical considerations in preventive interventions for bipolar disorder

“…30 Another study of Cognitive Behavioral Therapy is underway in Germany among participants with a family history of affective or schizoaffective disorder aged 15 to 30 years and with a recent onset of depressive or manic symptomatology. 31 In summary, there is some evidence that mood symptoms in people with family history of BD can improve with treatment, although there is no evidence as yet that BD can be prevented. However, within these emerging interventions, ethical concerns such as the extent of possible benefits or harms require careful consideration.…”

An evidence map of psychosocial interventions for the earliest stages of bipolar disorder

“…The therapies are evenly divided between high-risk, 33,38 first-episode, 39–43 and early-onset (usually adolescent) populations. 44–50 …”

“…Of the five ongoing studies, 33–35,54–56 only one study 64 has reported any interim outcome data. In that study, ten adolescents who were offered mindfulness-based CBT showed significant reductions in anxiety and associated changes in emotional regulation, but non-significant decreases in depressive or manic symptoms.…”

“…Of the 92 abstracts selected for screening, 67 were eligible for detailed review (figure 1). 18 reports described therapies applicable to increased risk for bipolar disorder, 33–38 first-episode bipolar disorder, 39–43 and early-onset bipolar disorder 44–50 populations. Most approaches were interventions specific for bipolar disorder, but five reports (two for first episode and three for early onset) were aimed at young people with affective and non-affective psychoses (HORYZONS, 42 EPPIC, 43 SR-CBT, 44 and CBTpA 45 ) or individuals with many mental health problems (Youth Early-intervention Study 50 ).…”

Pharmacotherapy in Children and Adolescents at Clinical-High Risk for Psychosis and Bipolar Disorder

“…Interpersonal and Social Rhythm Therapy (IPSRT), which targets altered social and sleep patterns, showed encouraging findings in a pilot study conducted on 13 youths [126]. A randomized controlled multi-center clinical trial is currently being conducted to evaluate the efficacy and safety of a specific CBT for young people who are at risk of BD [127]. Availability of Alternative, Non-pharmacologic Treatment Options ▼ One major concern in mentally ill people is the availability of and access to effective interventions overall and especially with regards to psychotherapeutic interventions.…”