Goals in Focus: CBT for Motivational Negative Symptoms of Psychosis - a Randomized-controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Brief Negative Symptoms Scale (BNSS) - 'motivation and pleasure factor' score
研究概览
简要总结
This pilot feasibility trial aims to evaluate the "Goals in Focus" intervention for motivational negative symptoms in people with psychosis.
Goals in Focus interventions translate findings of basic clinical research on psychological mechanisms of motivational negative symptoms into a tailored and comprehensive novel psychological treatment program.
The current single-blind randomized-controlled study aims to test feasibility and to examine first estimates of the expected effect size of Goals in Focus to inform a subsequent fully-powered RCT.
The feasibility data will be used to improve on the trial design and the provision of the "Goals in Focus" intervention where necessary.
详细描述
The reduction of goal-directed behavior is a core issue in motivational negative symptoms of psychosis and accounts for the long-term decline in psychological wellbeing and psychosocial functioning. However, the available treatment options are rather unspecific and show only small effects on motivational negative symptoms. Interventions that directly target the relevant psychological mechanisms of motivational negative symptoms are likely to be more effective. With "Goals in Focus", we translated findings of basic clinical research on psychological mechanisms of motivational negative symptoms into a tailored and comprehensive novel psychological treatment program for people with motivational negative symptoms. The current study aims to test the feasibility of Goals in Focus and trial procedures and 2) to estimate the expected effect size to inform a subsequent fully-powered trial.
A single-blind randomized-controlled trial will be conducted at the outpatient clinic of the Universität Hamburg, Germany. Thirty participants diagnosed with a psychotic spectrum disorder and at least moderate motivational negative symptoms will be randomly assigned to either 24 sessions of "Goals in Focus" or to a 6-months waitlist control group. Assessments will be conducted at baseline (t0) and 6 months after baseline completion (t1). Feasibility and acceptance of "Goals in Focus" will be rated by practitioners and participants. Feasibility of the trial procedures will be evaluated, e.g., with regard to patient recruitment, retention-, and attendance rates. The primary outcome for effect size estimation is defined as group differences in motivational negative symptoms at t1, corrected for baseline values. Secondary outcomes include psychosocial functioning, psychological well-being, depressive symptoms, expressive negative symptoms, negative symptom factors and goal-pursuit in everyday life.
The treatment effect on the primary outcomes will provide the basis for the sample size calculation for a fully powered RCT. The feasibility data will be used to improve on the trial design and the provision of the "Goals in Focus" intervention where necessary.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICD-10 diagnosis of a schizophrenia spectrum disorder (confirmed by the Structured Clinical Interview for DSM V Clinical Version
- •at least moderate motivational negative symptoms (i.e., scores ≥ 3 (moderate) in two items or ≥ 4 (moderately severe) in one item of the 'motivation and pleasure factor' of the Brief Negative Symptom Scale (BNSS)
- •sufficient skills in German language to participate in psychological therapy
- •capable to engage in weekly therapy sessions of 50-minutes
- •prioritize the reduction of negative symptoms as their current goal for treatment
- •capable to give informed consent to participate in the trial
排除标准
- •being at immediate and serious risk to self or others
- •co-morbid diagnosis of alcohol or substance use disorder
- •intake of Benzodiazepines for >2 days per week
- •receiving any other psychological treatment aiming to reduce motivational negative symptoms
研究组 & 干预措施
Goals in Focus Therapy
Participants in this arm will receive 24 weekly sessions with Goals in Focus therapy (GiF) over 6 months.
干预措施: Goals in Focus (Behavioral)
Waitlist Control
Participants in this arm will not receive any psychological treatment for 6 months. After 6-months, they will receive 24 sessions of Goals in Focus Therapy.
结局指标
主要结局
Brief Negative Symptoms Scale (BNSS) - 'motivation and pleasure factor' score
时间窗: 6 months after baseline assessment
The primary outcome is defined as the change in motivational negative symptoms assessed with the 'motivation and pleasure factor' of the Brief Negative Symptoms Scale (BNSS). The BNSS is a 13-item semi-structured interview measuring negative symptoms on two factors, namely 'motivation and pleasure' and 'reduced expressivity'. The 'motivation and pleasure factor' includes seven items that measure the subscales of 'anhedonia', 'avolition', and 'asociality'. Symptoms are rated on a seven-point scale ranging from 0 "no impairment" to 6 "severe deficit"
次要结局
- Avolition, Asociality and Anhedonia(6 months after baseline assessment)
- Global Assessment of Functioning (GAF)(6 months after baseline assessment)
- Goal-pursuit within daily-life(6 months after baseline assessment)
- Calgary Depression Rating Scale for Schizophrenia (CDSS)(6 months after baseline assessment)
- Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)(6 months after baseline assessment)
- Role Functioning Scale (RFS)(6 months after baseline assessment)
研究者
Matthias Pillny
Trial Manager
University of Hamburg-Eppendorf