Behavioural Activation for Bipolar Depression (BA-BD): A Case Series Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%)
研究概览
简要总结
Bipolar Disorders affect around 2% of the population. Most people with Bipolar experience depression; these periods can cause difficulties with relationships, work and daily life.
Psychological therapies for "unipolar" depression (for people who experience depression but never mania or hypomania) are widely available, but there is little research in to how effective these therapies are for people with Bipolar. Knowing this could give greater choice to people with Bipolar in terms of the therapy they have, and how easy it is to get within the NHS. One such therapy is called Behavioural Activation (BA). BA is an established therapy for people with unipolar depression. It helps people to re-establish healthier patterns of activity, but so far there is very little research into offering BA to people with BD.
The current research involves a small number of people with Bipolar Depression receiving BA to see if it seems sensible and worthwhile to them, and to help us to make any necessary improvements to the therapy. The study is taking place in Devon and is sponsored by the University of Exeter. 12 people that are currently experiencing Bipolar Depression who choose to take part will receive up to 20 individual therapy sessions of BA that has been adapted for Bipolar Depression (BA-BD), and will complete regular questionnaires and interviews. The results of this study will not give the final answer on how effective BA is for people with bipolar depression, but will help to plan for a larger study that can answer this question.
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 minimise 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 Structured Clinical Interview for Diagnosis (SCID-5)
- •meeting diagnostic criteria for Bipolar I or II Disorder (SCID-5)
- •participants will require working knowledge of written and spoken English, sufficient to be able to make use of therapy and to be able complete research assessments without the need of a translator.
排除标准
- •current/past learning disability, organic brain change, substance dependence (drugs and alcohol) that would compromise 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 AccEPT clinic at the Mood Disorders Centre
- •currently lacking 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).
研究组 & 干预措施
3 week wait
Participant waits for 3 weeks after their baseline assessment before commencing therapy.
干预措施: Behavioural Activation (BA) (Other)
4 week wait
Participant waits for 4 weeks after their baseline assessment before commencing therapy.
干预措施: Behavioural Activation (BA) (Other)
5 week wait
Participant waits for 5 weeks after their baseline assessment before commencing therapy.
干预措施: Behavioural Activation (BA) (Other)
6 week wait
Participant waits for 6 weeks after their baseline assessment before commencing therapy.
干预措施: Behavioural Activation (BA) (Other)
7 week wait
Participant waits for 7 weeks after their baseline assessment before commencing therapy.
干预措施: Behavioural Activation (BA) (Other)
8 week wait
Participant waits for 8 weeks after their baseline assessment before commencing therapy.
干预措施: Behavioural Activation (BA) (Other)
结局指标
主要结局
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)
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.
Qualitative feedback from participants
时间窗: through study completion, an average of 7 months
Written and verbal feedback of participants
Qualitative feedback from therapists
时间窗: through study completion, an average of 7 months
Feedback given in qualitative interviews with therapists
Therapy completion rate
时间窗: through study completion, an average of 7 months
Proportion of participants that attend at least 8 treatment sessions
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
次要结局
- Brief Quality of Life in Bipolar Disorder (Brief QoLBD)(1 week)
- Beck Depression Inventory (BDI)(1 week)
- Structured Clinical Interview for Depression (SCID)(Six months)
- Behavioral Activation for Depression Scale (BADS)(1 week)
- Snaith-Hamilton Pleasure Scale (SHAPS)(1 week)
- Positive and Negative Urgency Subscales of the UPPS-P Impulsive Behavior Scale(6 months)
- Questions about Suffering, Struggling and Engagement in Valued Activities(24 hours)
- Altman Self-Rating Mania Scale (ASRM)(1 week)
- Bech-Rafaelsen Mania Scale(1 week)
- Work and Social Adjustment Scale (WSAS)(24 hours)
- Hamilton Depression Scale (HAM-D)(1 week)
- General Anxiety Disorder Assessment - 7 (GAD7)(2 weeks)
- Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)(2 weeks)