Integrating Health Psychology Into Hepatitis c Treatment: a Self-efficAcy Intervention to reDuce Injecting Risk behAviour and hePatitis c reinfecTion Rates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Injecting Risk Behaviour
研究概览
简要总结
The study evaluates the use of implementation intentions to increase self-efficacy and reduce injecting risk behaviour in a sample of injecting drug users on treatment for hepatitis C (HCV). The overall aim is to reduce HCV reinfection rates. The primary objective is to identify lower injecting risk behaviour scores in patients on treatment for hepatitis C receiving the psychosocial intervention compared to the same patient group assigned to the control group.
详细描述
The intervention will entail completing a volitional help sheet.This will create implementation intentions, which are self-regulatory strategies taking the form of "if-then" plans (i.e. situation-solution plan).
Injecting risk behaviour scores and self-efficacy scores will be analysed for differences between intervention and control groups.
To control for contact-time with the researchers, participants in the control group will spend approximately 20 minutes with the researcher exploring Zimbardo's time perspective constructs (ZTPI, Zimbardo & Boyd, 1999) and completing the short Zimbardo's time perspective inventory (Orosz et al. 2017). The inventory was selected because the cognitive processes involved in accessing time constructs will also be activated in the intervention group for the planning of coping strategies and goal achievement during future injecting risk situations.
The study also aims:
- To assess the variability in injecting risk behaviour as explained by subjective norms, social connectedness and group identification constructs;
- To assess the variability in intervention effectiveness as explained by changes in mental health, illness perception subjective norms, social connectedness, and group identification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
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
- •Male or Female. (Over 18 years of age);
- •Chronic HCV positive infection;
- •Current illicit drug use established through participants' self-report;
- •Current HCV treatment provided by the NHS;
- •Informed consent, agreeing to study and monitoring criteria;
- •English-speaking.
排除标准
- •Inability to provide informed consent;
- •Aggressive or violent behaviour;
- •Not currently receiving HCV treatment;
- •Inability to communicate in English.
结局指标
主要结局
Injecting Risk Behaviour
时间窗: 4 weeks
Self-reported injecting risk behaviour over the past 4 weeks. Seventeen items scored 1-4 (1 frequently, 4 never)
Self-Efficacy
时间窗: 4 weeks
Self-reported confidence in one's own ability to refuse sharing of injecting equipment and use of old injecting equipment. Fifteen items scored 1-7 (1 high confidence, 7 low confidence)
次要结局
- Group Identification(Up to 8 weeks)
- Anxiety(2 weeks)
- Working alliance(Treatment duration (12 weeks))
- Social Connectedness(Up to 8 weeks)
- Depression(2 weeks)
- Post traumatic stress disorder(1 month)
- Subjective Norms(Up to 4 weeks)
- Illness perception(Up to 8 weeks)
研究者
John Dillon
Professor
University of Dundee