Adjunctive Behavioural Activation for Bipolar Depression: A Case Series (BA-BD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Therapy uptake rate
研究概览
简要总结
Bipolar disorder (BD) affects between 1-3% of the world's population. People with BD experience episodes of mania or hypomania and in most cases, they experience periods of depression which can cause difficulties in daily life. Psychological therapies for people experiencing depression without mania or hypomania are widely available, but there is little research into how effective these therapies are for people with BD. Behavioral activation therapy (BA) is based on behavioral theory and has been proven to be an effective treatment for unipolar depression. It helps people re-establish healthier activity patterns and sleep regulation, especially in BD for mood stabilization. BA is theoretically and clinically well matched to the treatment of bipolar depression, but there is still very little research into offering BA to people with BD.
The first aim of the current research is to implement BA for people with depression in Bipolar Disorder and study if it is feasible for this patient group. The second aim is to do a pilot study on the effectiveness of the treatment for this patient group. The research will be implemented with people seeking treatment at the specialized service for bipolar disorder at Landspítali University Hospital in Iceland. The participants will receive treatment as usual and the BA will be adjunctive.
At least ten people, that are currently experiencing Bipolar Depression and are willing to take part, will receive up to 20 individual therapy sessions of BA that have been adapted for Bipolar Depression (BA-BD), and will complete regular questionnaires and interviews.
The study will be a replication study to validate the previous study's findings by Kim, W. et al., 2022 in another setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
It is not possible to blind the assessor to phase or baseline duration of participants in the case-series, as the length of time between assessments will reveal this. Nevertheless, the assessor and clients will be asked not to disclose which therapist is treating them. Use of self-report measures as the primary outcome measure is intended to minimize potential biases on the side of the researcher.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scoring in the clinical range on a self-report measure of depression severity (the PHQ-9) meeting diagnostic criteria for depression based on a diagnosis on Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
- •meeting diagnostic criteria for Bipolar I or II Disorder DIAMOND) participants will require a working knowledge of written and spoken Icelandic, sufficient to make use of therapy and complete research assessments without the need for a translator.
排除标准
- •current/past learning disability, organic brain change, substance dependence (drugs and alcohol) that would compromise the ability to use therapy
- •current marked risk to self (i.e., self-harm or suicide) that we deem could not be appropriately managed in the Bipolar outpatient clinic at Landspitali.
- •currently lacking the capacity to give informed consent
- •currently receiving other psychosocial therapy for depression or bipolar disorder
- •presence of another area of difficulty that the therapist and client believe should be the primary focus of intervention (for example, Post-Traumatic Stress Disorder, psychosis)
结局指标
主要结局
Therapy uptake rate
时间窗: through study completion, an average of 7 months
Number of participants randomised who attend at least 1 treatment session
Therapy completion rate
时间窗: through study completion, an average of 7 months
Proportion of participants that attend at least 8 treatment sessions
Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%)
时间窗: through study completion, an average of 7 months
Participants' weekly completion of the Patient Health Questionnaire-9 (PHQ-9)
Change in activity levels as measured by consumer connected health devices
时间窗: through study completion, an average of 7 months
Measures of activity levels as by Withings health devices
Change in Sleep Duration measured by health device
时间窗: through study completion, an average of 7 months
Measures of sleep duration by Withings health devices
No significant adverse reaction for participants
时间窗: through study completion, an average of 7 months
Participant reports of adverse events elicited by researchers and therapists
次要结局
- Brief Quality of Life in Bipolar Disorder (Brief QoLBD)(1 week)
- Altman Self-Rating Mania Scale (ASRM)(1 week)
- Hamilton Depression Scale (HAM-D)(1 week)
- Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)(Six months)
- The Quality of Behavioral Activation Scale (Q-BAS)(1 week)
- Work and Social Adjustment Scale (WSAS)(24 hours)
- Behavioral Activation for Depression Scale (BADS)(1 week)
- Snaith-Hamilton Pleasure Scale (SHAPS)(1 week)
- Young mania rating scale(48 hours)
- General Anxiety Disorder Assessment - 7 (GAD7)(2 weeks)
- Six daily questions(24 hours)
研究者
Brynja Bjork Magnusdottir
Assistant professor, Psychologist
Reykjavik University