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Adjuvant psychotherapy in early-stage bipolar disorder: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Bipolar disorders are serious illnesses with a chronic course and a high rate of relapse. Typically, bipolar disorders onset during adolescence or early adulthood, with patients experiencing significant personal and social costs as a consequence of their illness. Despite this, to date, there is limited (controlled) evidence regarding the effectiveness of psychotherapy during the critical stages of the disorder (e.g., early onset). Some preliminary studies suggest that targeted, tailored early interventions in particular may improve disease prognosis. The proposed study examines the effectiveness of group psychotherapy on relapse prevention, global adaptive functioning, and neuropsychological functioning in early-stage bipolar disorder. METHODS:In this multicenter randomized controlled trial (RCT), 300 patients with bipolar disorder are randomized to one of two group psychotherapies: Specific Emotional-Cognitive Therapy (SECT; intervention group) or Emotion-Focused Supportive Therapy (EFST; active control group). Each therapy comprises of a total of 48-h sessions (delivered once a month) over a period of 4 months. Assessments take place at baseline (t1); 6 months follow-up, i.e., post-intervention (t2); 12?months follow-up (t3); and 18?months follow-up (t4), whereby 18?months follow-up is the primary time point of interest. DISCUSSION:The goal of this study is to test the effects of an innovative, specific group therapy relative to an active control condition in terms of rates of relapse, global functioning, and neuropsychological functioning. Pending the outcomes of the trial, it will be possible to establish a firm evidence base for accessible group psychotherapy adjuvant to routine psychiatric care for individuals with bipolar disorder. TRIAL REGISTRATION:USA: ClinicalTrials.gov NCT02506322 . Registered on 19 December 2014; Germany: German Clinical Trials Register DRKS00006013 . Registered on21 May 2015.

SUBMITTER: Stamm TJ

PROVIDER: S-EPMC7552468 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Adjuvant psychotherapy in early-stage bipolar disorder: study protocol for a randomized controlled trial.

Stamm Thomas J TJ Zwick Julia C JC O'Malley Grace G Sondergeld Lene-Marie LM Hautzinger Martin M

Trials 20201013 1

<h4>Background</h4>Bipolar disorders are serious illnesses with a chronic course and a high rate of relapse. Typically, bipolar disorders onset during adolescence or early adulthood, with patients experiencing significant personal and social costs as a consequence of their illness. Despite this, to date, there is limited (controlled) evidence regarding the effectiveness of psychotherapy during the critical stages of the disorder (e.g., early onset). Some preliminary studies suggest that targeted ...[more]

PMID: 33050952

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Project description:BackgroundObsessive-compulsive disorder (OCD) in children can lead to a huge burden on the concerned patients and their family members. While successful state-of-the art cognitive behavioral interventions exist, there is still a lack of available experts for treatment at home, where most symptoms manifest. Internet-based cognitive behavioral therapy (iCBT) could overcome these restrictions; however, studies about iCBT in children with OCD are rare and mostly target computerized self-help resources and only email contact with the therapist. Therefore, we intended to build up and to evaluate an iCBT approach for children with OCD, replacing successful elements of traditional in-office face-to-face CBT, with face-to-face teleconferences, online materials, and apps.MethodsWith the help of a pilot feasibility study, we developed the iCBT consisting of 14 teleconference sessions with the child and parents. The sessions are supported by an app assessing daily and weekly symptoms and treatment course completed by children and parents. Additionally, we obtain heart rate and activity scores from the child via wristbands during several days and exposure sessions. Using a waiting list randomized control trial design, we aim to treat and analyze 20 children with OCD immediately after a diagnostic session whereas the control group of another set of 20 OCD patients will be treated after waiting period of 16 weeks. We will recruit 30 patients in each group to take account for potential dropouts. Outcomes for the treatment group are evaluated before randomization (baseline, t0), 16 weeks (end of treatment, t1), 32 weeks (follow-up 1, t2), and 48 weeks after randomization (follow-up 2, t3). For the waiting list group, outcomes are measured before the first randomization (baseline), at 16 weeks (waiting list period), 32 weeks (end of treatment), 48 weeks after the first randomization (follow-up I), and 64 weeks after the first randomization (follow-up II).DiscussionBased on our experience of feasibility during the pilot study, we were able to develop the iCBT approach and the current study will investigate treatment effectiveness. Building up an iCBT approach, resembling traditional in-office face-to-face therapy, may ensure the achievement of well-known therapy effect factors, the acceptance in both patients and clinicians, and the wide distribution within the health system.Trial registrationClinicalTrials.gov NCT05037344 . Registered May 2019, last release August 13th, 2021.

Project description:BACKGROUND:The primary objective of this randomised controlled trial (RCT) is to establish the effectiveness of a novel online quality of life (QoL) intervention tailored for people with late stage (? 10 episodes) bipolar disorder (BD) compared with psychoeducation. Relative to early stage individuals, this late stage group may not benefit as much from existing psychosocial treatments. The intervention is a guided self-help, mindfulness based intervention (MBI) developed in consultation with consumers, designed specifically for web-based delivery, with email coaching support. METHODS/DESIGN:This international RCT will involve a comparison of the effectiveness and cost-effectiveness of two 5-week adjunctive online self-management interventions: Mindfulness for Bipolar 2.0 and an active control (Psychoeducation for Bipolar). A total of 300 participants will be recruited primarily via social media channels. Main inclusion criteria are: a diagnosis of BD (confirmed via a phone-administered structured diagnostic interview), no current mood episode, history of 10 or more mood episodes, no current psychotic features or active suicidality, under the care of a medical practitioner. Block randomisation will be used for allocation to the interventions, and participants will retain access to the program for 6 months. Evaluations will be conducted at pre- and post- treatment, and at 3- and 6- months follow-up. The primary outcome measure will be the Brief Quality of Life in Bipolar Disorder Scale (Brief QoL.BD), collected immediately post-intervention at 5 weeks (T1). Secondary measures include BD-related symptoms (mania, depression, anxiety, stress), time to first relapse, functioning, sleep quality, social rhythm stability and resource use. Measurements will be collected online and via telephone assessments at baseline (T0), 5 weeks (T1), three months (T2) and six months (T3). Candidate moderators (diagnosis, anxiety or substance comorbidities, demographics and current treatments) will be investigated as will putative therapeutic mechanisms including mindfulness, emotion regulation and self-compassion. A cost-effectiveness analysis will be conducted. Acceptability and any unwanted events (including adverse treatment reactions) will be documented and explored. DISCUSSION:This definitive trial will test the effectiveness and cost-effectiveness of a novel QoL focused, mindfulness based, online guided self-help intervention for late stage BD, and investigate its putative mechanisms of therapeutic action. TRIAL REGISTRATION:ClinicalTrials.gov : NCT03197974 . Registered 23 June 2017.

Project description:Bipolar II disorder (BP-II) is associated with marked morbidity and mortality. Quetiapine, the treatment with greatest evidence for efficacy in BP-II depression, is associated with metabolic burden. Psychotherapy, a treatment with few side effects, has not been systematically evaluated in BP-II. This study compared psychotherapy plus placebo to psychotherapy plus pharmacotherapy as treatments for BP-II depression. From 2010 to 2015, unmedicated adults (n = 92) with DSM-IV-TR BP-II depression were randomly assigned to weekly sessions of Interpersonal and Social Rhythm Therapy (IPSRT) plus placebo or IPSRT plus quetiapine and followed for 20 weeks. For primary outcomes, IPSRT + quetiapine yielded significantly faster improvement on 17-item Hamilton Depression Rating Scale (F₁,₁₁₅.₄ = 3.924, P = .048) and greater improvement on Young Mania Rating Scale (F₅₈.₅ = 4.242, P = .044) scores. Both groups, however, improved significantly over time with comparable response rates (≥ 50% reduction in depression scores): 67.4% (62/92) in the entire sample, with no between-group differences. Those randomly assigned to their preferred treatment were 4.5 times more likely to respond (OR = 4.48, 95% CI = 1.20-16.77, P = .026). IPSRT + quetiapine assignment was associated with significantly higher body mass index over time (F₆₇.₉₆ = 6.671, P = .012) and rates of dry mouth (79% v. 58%; χ² = 4.0, P = .046) and a trend toward more complaints of oversedation (100% vs 92%; χ² = 3.4, P = .063). IPSRT plus quetiapine resulted in greater symptomatic improvement but also more side effects than IPSRT alone. A subset of participants improved with IPSRT alone, although absence of an inactive comparator limits interpretation of this finding. Receipt of preferred treatment was associated with better outcomes. Harms, benefits, and preferences should be considered when recommending treatments for BP-II depression. ClinicalTrials.gov identifier: NCT01133821.

Project description:Cognitive dysfunction is a major feature of bipolar disorder with psychosis and is strongly associated with functional outcomes. Computer-based cognitive remediation has shown promise in improving cognition in patients with schizophrenia. However, despite similar neurocognitive deficits between patients with schizophrenia and bipolar disorder, few studies have extended neuroscience-based cognitive remediation programs to this population.The Treatment to Enhance Cognition in Bipolar Disorder study is an investigator-initiated, parallel group, randomized, blinded clinical trial of an Internet-based cognitive remediation protocol for patients with bipolar disorder I with psychosis (n = 100). We also describe the development of our dose-matched active control paradigm. Both conditions involve 70 sessions of computer-based activities over 24 weeks. The control intervention was developed to mirror the treatment condition in dose and format but without the neuroplasticity-based task design and structure. All participants undergo neuropsychological and clinical assessment at baseline, after approximately 25 hours of study activities, post treatment, and after 6 months of no study contact to assess durability. Neuroimaging at baseline and post treatment are offered in an "opt-in" format. The primary outcomes are scores on the MATRICS battery; secondary and exploratory outcomes include measures of clinical symptoms, community functioning, and neuroimaging changes. Associations between change in cognitive measures and change in community functioning will be assessed. Baseline predictors of treatment response will be examined.The present study is the first we are aware of to implement an Internet-based cognitive remediation program in patients with bipolar disorder with psychosis and to develop a comparable web-based control paradigm. The mixed online and study-site format allows accessible treatment while providing weekly staff contact and bridging. Based on user-provided feedback, participant blinding is feasible.ClinicalTrials.gov NCT01470781 ; 11 July 2011.

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Adjuvant psychotherapy in early-stage bipolar disorder: study protocol for a randomized controlled trial.

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Adjuvant psychotherapy in early-stage bipolar disorder: study protocol for a randomized controlled trial.

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