Evaluating a Multi-component Group Intervention for Improving Psychological Well-being of Trainee Civil Servants in Pakistan: a Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- The Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
Political and civil instability in Pakistan has placed many segments of society under stress. A 5-session group intervention incorporating principles of stress management, problem solving, behavioural activation, peer-support and adaptive leadership has been developed and successfully piloted for business professionals working under stressful conditions in Pakistan. The aim of this study is to evaluate the effectiveness of an adapted version of the intervention in improving psychological well-being amongst a group of trainee civil servants in the country.
A two-arm single blind, randomised controlled trial of the group intervention will be conducted among trainee civil servants in Pakistan. The participants are newly inducted civil servants (n=240) undergoing a 6 months' induction training. The participants will be randomised on a 1:1 allocation ratio (120 in each arm), with the intervention arm receiving the group intervention integrated into their orientation sessions and the control arm receiving orientation sessions alone. Outcome assessments will be conducted immediately post-intervention and 3 months after the completion of the intervention. The primary outcomes will be change in the prevalence of psychological distress as measured by Patient Health Questionnaire-9 (PHQ-9) and improvement in coping strategies as measured by Brief Cope Questionnaire. Secondary outcomes include symptoms of anxiety (measured by Generalized Anxiety Disorder scale (GAD-7)), well-being (measured by WHO5 well-being index) and psychological capital (measured by Psychological Capital Questionnaire).
The primary analyses will be intent-to-treat consisting of all participants included, according to the groups in which they will be randomized. The primary analysis will involve comparing pre to post changes in prevalence of psychological distress and coping strategies of the participants randomly assigned to the two conditions, using Fisher's exact test. Primary analyses will be non-parametric tests; however sensitivity analyses will use parametric models such as linear and logistic regression to control for baseline values of the participants' characteristics.
Ethical principles of voluntary informed consent, maintaining anonymity and confidentiality, data management and storage will be followed.
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
- Single (Investigator)
盲法说明
Fidelity of masking will be ensured by having assessors guess the condition of each participant at the end of each assessment to assess the contamination across intervention and control arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All newly inducted civil servants attending the CTP at the CSA, Lahore, which is a six months residential training course, and
- •who give informed voluntary consent to take part in the study.
排除标准
- •Participants having a physical health condition that does not allow them to attend the sessions will be excluded.
结局指标
主要结局
The Patient Health Questionnaire-9 (PHQ-9)
时间窗: One of the primary end points is the prevalence of psychological distress at 3 months post intervention
One of the primary outcomes is change in the prevalence of psychological distress as measured by PHQ-9 in the intervention arm as compared to the control arm. The 9-item Patient Health Questionnaire (PHQ-9), incorporates DSM-IV depression diagnostic criteria with other key major depressive symptoms (Kroenke et al, 2001). Participants rate their responses on a 4-point Likert scale ranging from not at all to nearly every day. The PHQ-9 total severity score ranges from 0 to 27. Higher score represents high psychological distress. The PHQ-9 has been validated in the Urdu language, showing adequate sensitivity and specificity (Husain et al 2006) and has been used in recent studies in KP (Rahman et al, 2016).
Brief COPE
时间窗: Another primary end point is the improvement in coping strategies at 3 months post intervention
Another primary outcome is improvement in coping strategies measured by Brief COPE in the intervention arm as compared to the control arm. Brief COPE (Carver, 1997) is used to assess state coping (the way people cope with a specific stressful situation) and trait coping (the usual way people cope with stress in everyday life). It consists of 14 subscales i.e. active coping, planning, positive reframing, acceptance, humour, religion, use of emotional support, use of instrumental support, self-distraction, denial, venting, substance use, behavioral disengagement, and self-blame, with two items per sub-scale. The standard is to use sub-scale score. The score on each subscales ranges from 2 to 8. Higher score represents that person using the specific coping style a lot. Cronbach's alphas for the Brief COPE sub-scales range from 0.50 to 0.90 (Mayer, 2001).
次要结局
- Psychological Capital Questionnaire (PCQ)(The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention)
- Generalized Anxiety Disorder -7 scale (GAD-7)(The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention)
- WHO-5 well-being index (WHO-5)(The secondary outcome data will be collected at 1 week post intervention and at 3 months post intervention)