E-health Interventions for Common Mental Health Problems Among University Students in Sweden: Pilot Study of Transdiagnostic Internet-based Psychological Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Treatment Credibility and expectancy Questionnaire (CEQ).
研究概览
简要总结
This study comprises the pilot phase of a randomized controlled trial (NCT05085756) that will investigate the feasibility of a transdiagnostic CBT-based treatment for symptoms of depression and anxiety offered to Swedish university students. It will offer treatment to participants who have previously responded to a universal online mental health screen conducted in university setting (WHO-WMH-ICS survey).
The pilot study initially has a prospective single-group design where 30 college students with elevated depressive and/or anxiety symptoms are enrolled in 8 weeks of therapist-guided CBT treatment via the Internet. All participants included will receive treatment. Mid-treatment, participants that are judged to be at risk of treatment failure will be randomized (1:1 ratio) to either continued treatment with no change, or to receive added therapist-support intended to enhance outcome.
Pilot study outcomes include various aspects of feasibility: participant uptake, self-reported credibility and expectancy, adherence to treatment protocol and assessments, treatment satisfaction, potential adverse events, causes for premature termination of treatment, and procedures for providing additional therapist support to a subsample of participants after mid-treatment. Within-group effects for primary depression and anxiety measures will be quantified. A range of secondary measures are piloted for the subsequent randomized controlled trial. The assessment points for this study: Baseline; 8 points during treatment; post-treatment; 6-month follow-up; 12-month follow-up; 24 month follow up.
Note. This study is retrospectively registered; this registration was completed prior to any outcome data-analyses.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •College/university student at institution of higher education in Sweden
- •Score 5-19 on the PHQ-9, and/or
- •Score ≥5 on the GAD-7
- •Completed baseline assessment
排除标准
- •Pharmacotherapy for mental health issue during the past 3 weeks)
- •Concurrent psychological treatment during the past 3 weeks
- •Mild levels of mental ill-health (under cut-off for primary outcome measures)
- •Severe levels of mental ill-health
- •Suicidal ideation or plans
结局指标
主要结局
Treatment Credibility and expectancy Questionnaire (CEQ).
时间窗: Baseline
Credibility/expectancy. \[Feasibility and acceptability measure\]
Working Alliance Inventory - Short (WAI-S)
时间窗: Mid-treatment (4 weeks)
The WAI-S is scale measuring the participants perceived working alliance with their therapist. \[Feasibility and acceptability measure\]
Treatment interest/uptake. Measured in terms of % participants who responded to the study invitation
时间窗: Baseline
Interest for intervention \[Feasibility and acceptability measure\]
Treatment completion/adherence.
时间窗: Post-treatment (8 weeks)
Adherence to the treatment protocol. Measured in terms of % completed modules and % of completed skills practices. \[Feasibility and acceptability measure\]
Assessment completion/adherence.
时间窗: Post-treatment (8 weeks)
Adherence to assessment plan (% missing data). Measured in terms of % completed measures at post-treatment. \[Feasibility and acceptability measure\]
Added therapist support.
时间窗: Mid-treatment (4 weeks)
Measured as % of participants who are randomized to receive additional therapist support for the remainder of the treatment period (weeks to 8).
Negative Effects Questionnaire (NEQ-20)
时间窗: Mid-treatment (4 weeks)
NEQ-20 investigate negative effects of psychological treatment. Total range is 0-80, with higher values representing a worse outcome. \[Feasibility and acceptability measure\]
The Client Satisfaction Questionnaire-8 (CSQ-8)
时间窗: Post-treatment (8 weeks)
Treatment satisfaction \[Feasibility and acceptability measure\]
Early treatment termination.
时间窗: Post-treatment (8 weeks)
Measured as % of participants who decide to end treatment early. This includes reporting participants' reasons for early termination, where provided. \[Feasibility and acceptability measure\]
次要结局
- Generalized Anxiety Disorder scale (GAD-7)(Baseline, during treatment (weekly), post-treatment (8 weeks), follow-up at 6, 12, and 24 months)
- Insomnia Severity Index (ISI)(Baseline; mid-treatment (4 weeks); post-treatment (8 weeks); follow-up at 6, 12, and 24 months)
- Alcohol Use Disorders Identification Test - Consumption (AUDIT-C).(Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months)
- World Health Organization Quality of Life Scale (WHOQOL-Bref).(Baseline; follow-up at 12 and 24 months)
- Attitudes towards professional help (ATSPPHS)(Baseline; follow-up at 12 and 24 months)
- Behavioral Activation for Depression Scale (BADS-9(Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months)
- Skills of Cognitive Therapy (SoCT)(Baseline; mid-treatment (4 weeks); post-treatment (8weeks); 24-month follow-up)
- Difficulties in Emotion-Regulation Scale (DERS-16).(Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months)
- Penn-State Worry Questionnaire (PSWQ)(Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months)
- World Health Organization Well-being questionnaire (WHO-5).(Baseline; During treatment (weekly); post-treatment (8 weeks); follow-up at 6, 12, and 24 months)
- Patient Health Questionnaire PHQ-9(Baseline, during treatment (weekly), post-treatment (8 weeks), follow-up at 6, 12, and 24 months)
- Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure (DSM-5 CCSM)(Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months)
- Rosenberg Self-Esteem Scale (RESES)(Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months)
- Connor-Davidson Resilience Scale.(Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months)
- Big Five Inventory-10 (BFI-10)(Baseline; follow-up at 12 and 24 months)
- Healthcare consumption and productivity loss in patients with a psychiatric disorder (TIC-P)(Baseline; follow-up at 6, 12, and 24 months)