跳至主要内容
临床试验/NCT07721870
NCT07721870已完成不适用

Meeting Psychiatric Challenges in Primary Care Via Low-Threshold Digital Mental Health Interventions

Uppsala University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2025年10月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
1
主要终点
Daily Mood Assessment

研究概览

简要总结

This study evaluates potential help for mild to moderate psychological distress in primary care patients. The study offers a choice between two interventions, both offered online (in a digital format). One intervention targets five key daily behaviors found to reduce depression and anxiety in earlier studies. The second intervention, also found to reduce depression and anxiety in earlier studies, targets relationship issues through a forgiveness process.

The study is designed as a single-case study where each individual is followed in detail over a period of 10 weeks, with a one-week follow-up after 3 months. In the first two weeks, participants fill in daily mood assessments and answer a brief questionnaire once every week. Then, participants start the intervention they chose, and continue to fill in the same questions, both daily and once a week. The intervention phase lasts five weeks. Then participants continue to fill in the daily mood assessments and weekly questionnaire for three more weeks. After three months, participants do the daily and weekly assessments for one final week.

The results will be analyzed at the individual level and, if enough participants join, at a group level. No one will be personally identified in any way when results are reported.

The study is exploratory, meaning that the researchers want to know which interventions participants tend to choose most often, whether the interventions appeal to participants, how long they stay in the study, and how they use the intervention material. The researchers also want to know what changes participants think would be needed for future studies or implementation in primary care clinics.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • Mild to moderate self-reported depression (score of <20 and >4 on the PHQ-9) AND/OR
  • Mild to moderate anxiety symptoms (score of >4 on the GAD-7)

排除标准

  • Ongoing psychological treatment
  • Recently initiated medication for regulating mood or emotions (past 3 weeks)
  • Scores of >19 or <5 on the PHQ-9
  • Scores of <5 on the GAD-7
  • Current suicidal thoughts or plans according to item 9 of the PHQ-9.

研究组 & 干预措施

TYD choice

Other

Choosing Things You Do (TYD) means option to participate in a mini-course online and then aim to perform the five TYD behaviors as much as possible. More specifically, the TYD intervention begins with three brief modules covering psychoeducational content regarding mental health, the TYD framework and the identification of personally relevant behaviors. The intervention then entails completing app-based daily tasks, including a daily activity diary, daily inspirational notes and weekly reflection prompts.

干预措施: Things You Do (TYD) (Behavioral)

Choice of REACH intervention

Other

Participants choose the REACH forgiveness of others intervention. This choice means completing an online workbook with 12 lessons focusing in sequence on the five REACH components.

干预措施: REACH (Behavioral)

结局指标

主要结局

Daily Mood Assessment

时间窗: Daily during 2-week baseline phase/daily during 5-week intervention period/daily during 3-week post-intervention period/daily during one-week follow-up at 14 weeks after study inclusion.

The main repeated outcome is a daily mood composite derived from six questions developed specifically for this study (daytime mood, interest or pleasure in activities, sleep, energy, anxiety level and anxiety control) rated on 1-10 visual analogue scales (VAS), with higher scores on the scale indicating better mood. Specific questions were developed for this study and are available on request.

次要结局

  • Patient Health Questionnaire-9 (PHQ-9)(Weekly during 2-week baseline phase/weekly during 5-week intervention period/weekly during 3-week post-intervention period/once during one-week follow-up at 14 weeks after study inclusion.)
  • Generalized Anxiety Disorder (GAD-7)(Weekly during 2-week baseline phase/weekly during 5-week intervention period/weekly during 3-week post-intervention period/once during one-week follow-up at 14 weeks after study inclusion.)
  • 5-item World Health Organization Well-Being Index (WHO-5)(Weekly during 2-week baseline phase/weekly during 5-week intervention period/weekly during 3-week post-intervention period/once during one-week follow-up at 14 weeks after study inclusion.)
  • Trait Forgivingness Scale (TFS)(Weekly during 2-week baseline phase/weekly during 5-week intervention period/weekly during 3-week post-intervention period/once during one-week follow-up at 14 weeks after study inclusion.)
  • Things You Do (TYD) Questionnaire(Weekly during 2-week baseline phase/weekly during 5-week intervention period/weekly during 3-week post-intervention period/once during one-week follow-up at 14 weeks after study inclusion.)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne H Berman

Professor

Uppsala University

研究点 (1)

Loading locations...

相似试验