Feasibility, Acceptability and Preliminary Clinical Outcome Signals Following a Digital Things You Do (TYD) Intervention in Primary Care: A Single-case Study
Meeting Psychiatric Challenges in Primary Care Via Low-Threshold Digital Mental Health Interventions
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Varberg、瑞典
- Halland Primary Care
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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其他:TYD choice
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.
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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.
The length of the intervention period is set at five weeks in this study.
其他名称:
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其他:Choice of REACH intervention
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.
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This choice means completing an online workbook with 12 lessons focusing in sequence on the five REACH components, intended to alleviate feelings associated with a past hurt that the participant has experienced, usually from another person.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Daily Mood Assessment
大体时间: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.
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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.
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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.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Patient Health Questionnaire-9 (PHQ-9)
大体时间: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.
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Score range 1-27, higher values mean worse outcomes.
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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.
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Generalized Anxiety Disorder (GAD-7)
大体时间: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.
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Score range 1-21, higher values mean worse outcomes
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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.
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5-item World Health Organization Well-Being Index (WHO-5)
大体时间: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.
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Score range 20-100, higher values mean better outcomes
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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.
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Trait Forgivingness Scale (TFS)
大体时间: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.
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The 10-item TFS measures the personality trait of being a forgiving person (Berry' Worthington' O'Connor' Parrott' & Wade' 2005).
Score range 5-50 (items 1, 3, 6, 7 and 8 are reversed).
Higher scores mean higher levels of forgivingness.
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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.
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Things You Do (TYD) Questionnaire
大体时间: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.
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The TYD-15 questionnaire includes 15 items that measure the frequency of TYD behaviors during the past week.
Participants respond on a five-point Likert scale from 'Not at all' (0) to 'Every day' (4), with a score range of 0-60.
Higher scores indicate greater engagement in TYD behaviors.
TYD-15 shows good internal consistency with Cronbach's alpha between 0.87 and 0.90 (Bisby et al, 2024).
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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.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Internet Evaluation and Utility Questionnaire (IEUQ)
大体时间:Completed at the end of individual participant data collection; i.e., prior to 14-week follow-up in the event of participant attrition.
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The IEUQ is a "16-item measure designed to assess usability, likeability, usefulness, understandability, and convenience of the Internet intervention."
(Thorndike et al 2008, p. 6).
Score range of 0-64; higher scores mean better intervention utility.
Reference: Thorndike FP, Saylor DK, Bailey ET, Gonder-Frederick L, Morin CM, Ritterband LM.
Development and Perceived Utility and Impact of an Internet Intervention for Insomnia.
E J Appl Psychol.
2008;4(2):32-42.
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Completed at the end of individual participant data collection; i.e., prior to 14-week follow-up in the event of participant attrition.
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Additional intervention experiences
大体时间:Completed at the end of individual participant data collection; i.e., prior to 14-week follow-up in the event of participant attrition.
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Study-developed question: How would you describe your overall experience with the intervention, including any specific benefits, challenges or outcomes?
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Completed at the end of individual participant data collection; i.e., prior to 14-week follow-up in the event of participant attrition.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2025-04878-01
- 2024-01873 (其他赠款/资助编号:FORTE)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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