Internet-delivered Interventions for Stress, Anxiety and Depression in the Workplace
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- PHQ-4
研究概览
简要总结
The research will utilise an open feasibility parallel groups trial to examine the impact of novel internet-delivered cognitive behavioural therapy (CBT) interventions for stress, anxiety, and depression compared to treatment as usual (face to face counselling and psychotherapy) in an employment context. Participants will consist of employees accessing services provided by employee assistance programmes (EAP) provided at the European headquarters of a large technology organisation.
详细描述
Participants will be recruited for the online intervention through either self-referral or a referral from one of the counsellors or GPs at the onsite well-being service centre. Participants in the face-to-face group will be recruited by referral from a member of the EAP; those on the waiting list for face-to-face services provided by the EAP will be approached to participate in the research. At baseline, participants in both the online and the face-to-face groups will complete sociodemographic information, the PHQ-4, PSS-4, the HPQ-SF, as well as an assessment of risk using question 9 from the PHQ-9. Eligible participants in the online intervention group will be offered one of three internet-delivered CBT interventions (Space from Stress, Space from Anxiety, Space from Depression). Participants attending the onsite EAP counselling service will receive 8 sessions of counselling.
Risk Assessment
Participants will be screened at baseline for risk. This assessment will be conducted through the response to question 9 on the PHQ-9, in which respondents are requested to indicate how often they have been bothered by "thoughts that you would be better off dead or of harming yourself in some way" rated on a 4-point Likert scale, with 0 indicated "not at all", 1 = "several days", 2 = "more than half the days", 3 = "nearly every day". Any participant who scores > 1 will be automatically prompted to answer additional questions to qualify the level of risk indicated. These questions include "Do you have any current plans to end your life?", "Have you made any actual preparations towards ending your life?" answered in a simple "yes/no" format and "how likely is it that you will act on these thoughts or plans to end your life" rated on a 0=10 scale with 0 indicating "I would never do this" and 10 indicating "I am definitely going to do this". Participants are also asked an open-ended question about their protective factors "what is stopping you from acting on these thoughts?". If any risk to self or others is highlighted, the participant will be immediately provided with crisis contact numbers (GP Out of Hours, Samaritans, Aware, Pieta House, Women's Aid, Amen) through the platform, and encouraged to contact these services directly if they feel in crisis. In addition, participants who indicate risk at baseline will be recommended that they contact the onsite GP or one of the counsellors at the onsite wellness centre. Those who exceed the cut-off score for risk ( >1 PHQ-9 Question 9) on the screening questions will not be eligible to participate in the study and will be able to access support from the onsite GP and /or the counselling team at the onsite wellness centre.
During the course of the trial, all supporters who are trained mental health practitioners will remain alert for indications of risk and will escalate concerns within the established supervision governance structure in an appropriate time frame.
During treatment, participants in both the online interventions and the face-to-face intervention will complete the PHQ-4 and PSS-4. At the end of the treatment, participants will be asked to complete the PHQ-4, PSS-4, SAT, and the HPQ-SF. These measures will also be completed at 4-months follow-up. A mixed-method approach will be used to include quantitative and qualitative analysis of symptom severity, work performance, and user satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants will be 18+ years of age.
排除标准
- •Suicidal intent/ideation: score >1 on PHQ-9 question 9.
结局指标
主要结局
PHQ-4
时间窗: Up to 4-months
Patient health Questionnaire
PSS-4
时间窗: Up to 4-months
Perceived Stress Scale-4 (PSS-4)
次要结局
- Health and Work Performance Questionnaire (HPQ-SF)(Up to 4-months)
- Satisfaction with Treatment Questionnaire (SAT)(8 weeks)
