Effectiveness and Mediators of Change of an Online CBT Intervention for Students With Adjustment Disorder - Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 216
- 主要终点
- Change in Adjustment disorder
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of online cognitive-behavioral intervention based on Unified Protocol and mediators of obtained changes among polish students with adjustment disorder. The intervention is fully self-helped and based on Unified Protocol principles. Control conditions contain of online progressive muscle relaxation group and waiting list.
详细描述
Adjustment problems are highly prevalent among students around the world (Conley et.al., 2013). Unfortunately only half of students in need receive psychological help (Eisenberg et al., 2018). For these reasons, there is a need to develop and evaluate new, more scalable forms of treatment for students with adjustment disorder - such as internet therapeutic programs. Therefore the aim of the present research is to evaluate the effectiveness of online cognitive-behavioural therapy intervention. Mediators of obtained changes will also be evaluated. The present study has a potential for the development of a scalable, well researched treatment option for students experiencing adjustment disorder - internet psychological intervention.
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
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having a student status
- •18 years old or older,
- •having access to the internet and using computer or smartphone,
- •meeting the diagnostic criteria of adjustment disorder based on a total sum score > 47,5 in ADNM-20 questionnaire
- •meeting diagnostic criteria for AjD in MINI Interview.
排除标准
- •an increased risk of suicidality intent or ideation (at least moderate scores on the MINI and/or a score > 2 on item 9 from the PHQ-9),
- •psychotic disorder, eating disorder, anti-social personality disorder and/or alcohol/substance use disorder as indicated by the MINI
- •receiving another psychological treatment at the start of the study
- •having no time for participation in program
- •receiving pharmacological psychiatric treatment not stabilized 6 weeks prior the start of the study
研究组 & 干预措施
Internet CBT-UP intervention (iCBT-UP)
Patricipants in the experimental group will receive online cbt intervention for students with adjustment disorder (iCBT-UP).
干预措施: Internet CBT-UP intervention iCBT-UP (Behavioral)
Internet Progressive Muscle Realxation Training (iPMR)
Participants from the active control group will receive progressive muscle relaxation training (iPMR).
干预措施: Internet Progressive Muscle Realxation Training (iPMR) (Behavioral)
Waiting List
Participants from the waiting list condition will receive access to the choosen intervention after 6-weeks waiting period.
结局指标
主要结局
Change in Adjustment disorder
时间窗: measured at baseline, immediately after the interventions and 1 month follow up
Adjustment disorder - The Adjustment Disorder New Module 20 (ADNM-20)
次要结局
- Change in Depression(measured at baseline, immediately after the interventions and 1 month follow up)
- Change in General Anxiety Disorder(measured at baseline, immediately after the interventions and 1 month follow up)
- Change in Stress(measured at baseline, immediately after the interventions and 1 month follow up)
- Change in Satisfaction with life(measured at baseline, immediately after the interventions and 1 month follow up)
- Change in Academic Adjustment(measured at baseline, immediately after the interventions and 1 month follow up)
- Change in Experiential Avoidance(measured at baseline, immediately after the interventions and 1 month follow up)
- Change in Cognitive Fusion(measured at baseline, immediately after the interventions and 1 month follow up)
- Change in Self-compassion(7 days during the first week of the intervention and 7 days during the sixth week of the intervention time)
- Change in Mindfulness(measured at baseline, immediately after the interventions and 1 month follow up)
- Change in Persevative thinking(measured at baseline, immediately after the interventions and 1 month follow up)
- Change in Mental well-being(measured at baseline, immediately after the interventions and 1 month follow up)
- Change in Cognitive functioning(measured at baseline, immediately after the interventions and 1 month follow up)
- Change in Academic performance(measured at baseline, immediately after the interventions and 1 month follow up)
- Change in Daily Depressogenic adjustment(7 days during the first week of the intervention and 7 days during the sixth week of the intervention time)
- Change in Daily negative thinking(7 days during the first week of the intervention and 7 days during the sixth week of the intervention time)
- Change in Emotional regulation(7 days during the first week of the intervention and 7 days during the sixth week of the intervention time)
- Change in Daily-affect(7 days during the first week of the intervention and 7 days during the sixth week of the intervention time)
- Change in Procrastination(7 days during the first week of the intervention and 7 days during the sixth week of the intervention time)
- Change in Self-compassion(measured at baseline, immediately after the interventions and 1 month follow up)
研究者
Aleksandra Juszczyk
Msc Aleksandra Juszczyk-Kalina
University of Warsaw