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针对患有抑郁症的老年人的 iCBT:一项实用的初级保健随机对照试验

2026年9月21日 更新者:Göteborg University

新一代互联网:针对轻度至中度抑郁症老年人的 iCBT 治疗——初级保健背景下的一项务实随机对照试验

This clinical trial aims to evaluate the potential benefits of internet cognitive behavioural therapy (iCBT) for elderly patients with mild/moderate depression and compare its effectiveness with the current treatment as usual (TAU) at primary care centres (PCCs).

The specific aims are to study if:

iCBT is as effective as TAU in reducing depressive symptoms iCBT is as effective as TAU in increasing quality of life iCBT is as effective as TAU in increasing the function in patients >65 years and older with mild/moderate depression attending primary care, with the perspective of 36 months.

Participants will:

Work with the iCBT program (10-12 weeks) or become TAU at their PCCs. Followed-up at 3, 6, 12, 24 and 36 months of their symptoms, quality of life and function.

研究概览

地位

主动,不招人

详细说明

Study Objective:

The primary aim is to determine if iCBT is as effective for treating mild-moderate depression in older adults (<65) as it is for younger age groups. The study will assess various outcomes throughout 3, 6, 12, 24, and 36 months, including depressive symptoms, quality of life, workability, relationships, activities of daily living, and social participation.

Trial Design:

It's a randomised controlled trial (RCT) with two groups: intervention (iCBT) and control (TAU). The pragmatic design closely resembles real-world primary care conditions to ensure the results apply to routine clinical practice.

Population:

Participants will be recruited from primary care centres (PCCs) in Sweden, targeting individuals over 65 years diagnosed with mild to moderate depressive symptoms. The study aims to include all eligible patients from participating PCCs, ensuring a broad representation of the target population.

Intervention and Control:

Intervention:

iCBT program with minimal therapist contact, initiated promptly after inclusion and lasting 10-12 weeks. Weekly therapist/nurse contact via email or telephone is part of the intervention.

Control:

TAU according to Swedish National Guidelines may include guided self-help, face-to-face CBT (excluding iCBT), and/or antidepressants provided by GPs or nurses at the PCCs.

Patient Selection and Randomization:

Patients will be screened using standardised guidelines (NICE guidelines for depression), diagnosed via the MINI diagnostic interview (Mini International Neuropsychiatric Interview), and randomised centrally to avoid bias. Due to the nature of the intervention, blinding at the patient level isn't feasible, but efforts will be made to blind researchers during data analysis.

Follow-up and Data Collection:

Multiple follow-up points up to 36 months will allow the researchers to assess the longer-term effects of iCBT compared to TAU. Quantitative outcomes will be supplemented by qualitative data from focus group interviews with patients and staff, exploring their experiences with iCBT.

Focus Group Interviews:

These will involve patients and staff separately, aiming to gather insights into the acceptability, feasibility, and perceived effectiveness of iCBT in a primary care setting. Qualitative analysis methods will be used to interpret and contextualise the findings from these interviews.

研究类型

介入性

注册 (估计的)

390

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Gothenburg、瑞典
        • University of Gothenburg

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 及以上 (年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • All patients >65, attending PCCs engaged in the trial, with mood as well as somatic complaints will be asked about depressive symptoms during the last 2 weeks by NICE guidelines for depression.
  • All patients diagnosed with minor/major depression and not belonging to exclusion criteria and willing to take part in the trial will be diagnosed via the Mini International Neuropsychiatric Interview (M.I.N.I.) by a psychologist/specially trained nurse and have a General Practitioner (GP) somatic consultation

Exclusion Criteria:

Patients diagnosed with:

  • severe depression
  • prior suicide attempt or currently at medium to high risk of suicide (MADRS-S question 9>3 points or MINI suicide >9)
  • bipolar disorder
  • psychosis
  • addiction
  • cognitive impairment
  • not speaking or understanding Swedish.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:iCBT Senior

iCBT depression program with minimal therapist contact offered within 14 days from inclusion and with a duration of 10-12 weeks. Contact via email or telephone every week (therapist/nurse)

iCBT depression program with minimal therapist contact offered within 14 days from inclusion and with a duration of 10-12 weeks. Contact via email or telephone every week (therapist/nurse)

有源比较器:Depression treatment-as-usual Senior

Depression treatment-as-usual for patient >65 years

iCBT depression program with minimal therapist contact offered within 14 days from inclusion and with a duration of 10-12 weeks. Contact via email or telephone every week (therapist/nurse)

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
MADRS-S (Montgomery and Asberg Depression Rating Scale)
大体时间:Change from baseline scores MADRS-S scale at 3 months

What is the effect of iCBT on participants' symptoms of depression (measured as a change in score in MADRS-S from baseline to 3 months after baseline)?

Scale:

0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression

Change from baseline scores MADRS-S scale at 3 months
MADRS-S (Montgomery and Asberg Depression Rating Scale)
大体时间:Change from baseline scores MADRS-S scale at 6 months

What is the effect of iCBT on participants' symptoms of depression (measured as a change in score in MADRS-S from baseline to 6 months after baseline)?

Scale:

0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression

Change from baseline scores MADRS-S scale at 6 months
MADRS-S (Montgomery and Asberg Depression Rating Scale)
大体时间:Change from baseline scores MADRS-S scale at 12 months

What is the effect of iCBT on participants' symptoms of depression (measured as a change in score in MADRS-S from baseline to 12 months after baseline)?

Scale:

0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression

Change from baseline scores MADRS-S scale at 12 months
MADRS-S (Montgomery and Asberg Depression Rating Scale)
大体时间:Change from baseline scores MADRS-S scale at 24 months

What is the effect of iCBT on participants' symptoms of depression (measured as a change in score in MADRS-S from baseline to 24 months after baseline)?

Scale:

0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression

Change from baseline scores MADRS-S scale at 24 months
MADRS-S (Montgomery and Asberg Depression Rating Scale)
大体时间:Change from baseline scores MADRS-S scale at 36 months

What is the effect of iCBT on participants' symptoms of depression (measured as a change in score in MADRS-S from baseline to 36 months after baseline)?

Scale:

0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression

Change from baseline scores MADRS-S scale at 36 months

次要结果测量

结果测量
措施说明
大体时间
The 5-level EQ-5D version (EQ-5D-5L) EuroQol 5-Dimension
大体时间:Change from baseline scores EQ-5D scale at 3 months

Scale Title: EQ-5D-5L. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. 1 = no difficulties and 5 = very large difficulties. These single-digit codes can be combined into a five-digit code that corresponds to a specific health profile. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

What is the effect of iCBT on participants' health-related quality of life (measured by the change in scores in EQ-5D from baseline to 3 months after baseline)?

Change from baseline scores EQ-5D scale at 3 months
The 5-level EQ-5D version (EQ-5D-5L)
大体时间:Change from baseline scores EQ-5D scale at 6 months

What is the effect of iCBT on participants' health-related quality of life (measured by the change in scores in EQ-5D from baseline to 6 months after baseline? The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

Change from baseline scores EQ-5D scale at 6 months
The 5-level EQ-5D version (EQ-5D-5L)
大体时间:Change from baseline scores EQ-5D scale at 12 months

What is the effect of iCBT on participants' health-related quality of life (measured by the change in scores in EQ-5D from baseline to 12 months after baseline? The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

Change from baseline scores EQ-5D scale at 12 months
The 5-level EQ-5D version (EQ-5D-5L)
大体时间:Change from baseline scores EQ-5D scale at 24 months

What is the effect of iCBT on participants' health-related quality of life (measured by the change in scores in EQ-5D from baseline to 24 months after baseline? The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

Change from baseline scores EQ-5D scale at 24 months
The 5-level EQ-5D version (EQ-5D-5L)
大体时间:Change from baseline scores EQ-5D scale at 36 months

What is the effect of iCBT on participants' health-related quality of life (measured by the change in scores in EQ-5D from baseline to 36 months after baseline? The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

Change from baseline scores EQ-5D scale at 36 months
Work ability
大体时间:Change from baseline scores WAI scale at 3 months

Scale Title: Work Ability Index (WAI) Minimum Value: 7 Maximum Value: 49 Higher Scores Mean: A better outcome. The WAI is used to assess an individual's work ability based on their health and work capacity.What is the effect of iCBT on participants' work ability (measured as change in scores in WAI from baseline to 3 months after baseline). Work ability was measured by means of the Work Ability Index (WAI) which consists in a 7-part self-assessment: current ability, work ability in relation to physical and mental demands of the job, reported diagnosed diseases, estimated impairment due to health status, sick leave over the last 12 months, self-prognosis of work ability in the 2 years to come and mental resources of the individual. The WAI measured in this way ranges from 7 to 49 points and 4 categories have been suggested to describe WAI levels: poor (7-27), moderate (28-36), good (37-43) and excellent (44-49).

Change from baseline scores WAI scale at 3 months
Work ability
大体时间:Change from base-line scores WAI scale at 6 months

What is the effect of iCBT on participants' work ability (measured as change in scores in WAI from baseline to 6 months after baseline). Work ability was measured by means of the Work Ability Index (WAI) which consists in a 7-part self-assessment: current ability, work ability in relation to physical and mental demands of the job, reported diagnosed diseases, estimated impairment due to health status, sick leave over the last 12 months, self-prognosis of work ability in the 2 years to come and mental resources of the individual. The WAI measured in this way ranges from 7 to 49 points and 4 categories have been suggested to describe WAI levels: poor (7-27), moderate (28-36), good (37-43) and excellent (44-49).

Change from base-line scores WAI scale at 6 months
Work ability
大体时间:Change from base-line scores WAI scale at 12 months

What is the effect of iCBT on participants' work ability (measured as change in scores in WAI from baseline to 12 months after baseline). Work ability was measured by means of the Work Ability Index (WAI) which consists in a 7-part self-assessment: current ability, work ability in relation to physical and mental demands of the job, reported diagnosed diseases, estimated impairment due to health status, sick leave over the last 12 months, self-prognosis of work ability in the 2 years to come and mental resources of the individual. The WAI measured in this way ranges from 7 to 49 points and 4 categories have been suggested to describe WAI levels: poor (7-27), moderate (28-36), good (37-43) and excellent (44-49).

Change from base-line scores WAI scale at 12 months
Work ability
大体时间:Change from base-line scores WAI scale at 24 months

What is the effect of iCBT on participants' work ability (measured as change in scores in WAI from baseline to 24 months after baseline). Work ability was measured by means of the Work Ability Index (WAI) which consists in a 7-part self-assessment: current ability, work ability in relation to physical and mental demands of the job, reported diagnosed diseases, estimated impairment due to health status, sick leave over the last 12 months, self-prognosis of work ability in the 2 years to come and mental resources of the individual. The WAI measured in this way ranges from 7 to 49 points and 4 categories have been suggested to describe WAI levels: poor (7-27), moderate (28-36), good (37-43) and excellent (44-49).

Change from base-line scores WAI scale at 24 months
Work ability
大体时间:Change from base-line scores WAI scale at 36 months

What is the effect of iCBT on participants' work ability (measured as change in scores in WAI from baseline to 36 months after baseline). Work ability was measured by means of the Work Ability Index (WAI) which consists in a 7-part self-assessment: current ability, work ability in relation to physical and mental demands of the job, reported diagnosed diseases, estimated impairment due to health status, sick leave over the last 12 months, self-prognosis of work ability in the 2 years to come and mental resources of the individual. The WAI measured in this way ranges from 7 to 49 points and 4 categories have been suggested to describe WAI levels: poor (7-27), moderate (28-36), good (37-43) and excellent (44-49).

Change from base-line scores WAI scale at 36 months
WHODAS 12 2.0 (WORLD HEALTH ORGANIZATION DISABILITY ASSESSMENT SCHEDULE 2.0), 12-item version, self-administered
大体时间:Change from base-line scores WHODAS scale at 3 months

What is the effect of iCBT on participants' disability work (measured as a change in scores in WHODAS from baseline to 3 months after baseline)? This questionnaire asks about difficulties due to health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long-lasting, injuries, mental or emotional problems, and problems with alcohol or drugs.

Review the past 30 days and answer these questions, thinking about how difficult participant had to do the following activities. WHODAS 2.0 covers 6 Domains of Functioning, including Cognition - understanding & communicating; mobility- moving & getting around; self-care- hygiene, dressing, eating & staying alone; getting along- interacting with other people; life activities- domestic responsibilities, leisure, work & school, Participation- joining in community activities

Change from base-line scores WHODAS scale at 3 months
WHODAS 12 2.0 (WORLD HEALTH ORGANIZATION DISABILITY ASSESSMENT SCHEDULE 2.0), 12-item version, self-administered
大体时间:Change from base-line scores WHODAS scale at 6 months

What is the effect of iCBT on participants' disability work (measured as a change in scores in WHODAS from baseline to 6 months after baseline)? This questionnaire asks about difficulties due to health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long-lasting, injuries, mental or emotional problems, and problems with alcohol or drugs.

Review the past 30 days and answer these questions, thinking about how difficult participant had to do the following activities. WHODAS 2.0 covers 6 Domains of Functioning, including Cognition - understanding & communicating; mobility- moving & getting around; self-care- hygiene, dressing, eating & staying alone; getting along- interacting with other people; life activities- domestic responsibilities, leisure, work & school, Participation- joining in community activities

Change from base-line scores WHODAS scale at 6 months
WHODAS 12 2.0 (WORLD HEALTH ORGANIZATION DISABILITY ASSESSMENT SCHEDULE 2.0), 12-item version, self-administered
大体时间:Change from base-line scores WHODAS scale at 12 months

What is the effect of iCBT on participants' disability work (measured as a change in scores in WHODAS from baseline to 12 months after baseline)? This questionnaire asks about difficulties due to health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long-lasting, injuries, mental or emotional problems, and problems with alcohol or drugs.

Review the past 30 days and answer these questions, thinking about how difficult participant had to do the following activities. WHODAS 2.0 covers 6 Domains of Functioning, including Cognition - understanding & communicating; mobility- moving & getting around; self-care- hygiene, dressing, eating & staying alone; getting along- interacting with other people; life activities- domestic responsibilities, leisure, work & school, Participation- joining in community activities

Change from base-line scores WHODAS scale at 12 months
WHODAS 12 2.0 (WORLD HEALTH ORGANIZATION DISABILITY ASSESSMENT SCHEDULE 2.0), 12-item version, self-administered
大体时间:Change from base-line scores WHODAS scale at 24 months

What is the effect of iCBT on participants' disability work (measured as a change in scores in WHODAS from baseline to 24 months after baseline)? This questionnaire asks about difficulties due to health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long-lasting, injuries, mental or emotional problems, and problems with alcohol or drugs.

Review the past 30 days and answer these questions, thinking about how difficult participant had to do the following activities. WHODAS 2.0 covers 6 Domains of Functioning, including Cognition - understanding & communicating; mobility- moving & getting around; self-care- hygiene, dressing, eating & staying alone; getting along- interacting with other people; life activities- domestic responsibilities, leisure, work & school, Participation- joining in community activities

Change from base-line scores WHODAS scale at 24 months
WHODAS 12 2.0 (WORLD HEALTH ORGANIZATION DISABILITY ASSESSMENT SCHEDULE 2.0), 12-item version, self-administered
大体时间:Change from base-line scores WHODAS scale at 36 months

What is the effect of iCBT on participants' disability work (measured as a change in scores in WHODAS from baseline to 36 months after baseline)? This questionnaire asks about difficulties due to health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long-lasting, injuries, mental or emotional problems, and problems with alcohol or drugs.

Review the past 30 days and answer these questions, thinking about how difficult participant had to do the following activities. WHODAS 2.0 covers 6 Domains of Functioning, including Cognition - understanding & communicating; mobility- moving & getting around; self-care- hygiene, dressing, eating & staying alone; getting along- interacting with other people; life activities- domestic responsibilities, leisure, work & school, Participation- joining in community activities

Change from base-line scores WHODAS scale at 36 months
Use of Antidepressants
大体时间:Antidepressant use will be assessed at baseline and after 12 months of participation in the study.

The use of antidepressants will be assessed as a secondary outcome measure in this study to understand its impact on the treatment of mild to moderate depression in individuals aged 66 and above. Antidepressant use will be compared between the intervention group (receiving iCBT) and the control group (receiving Treatment-As-Usual, TAU) over a 12-month period.

Antidepressant use will be assessed at baseline and after 12 months of participation in the study.
General Self-Efficacy Scale (GSE)
大体时间:Change from base-line scores GSE scale at 3 months

The General Self-Efficacy Scale is correlated to emotion, optimism, work, satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout, and anxiety. Scoring: Not at all true, Hardly true, Moderately true, Exactly true, All questions 1 2 3 4. The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.

Change from base-line scores GSE scale at 3 months
General Self-Efficacy Scale (GSE)
大体时间:Change from base-line scores GSE scale at 6 months

The General Self-Efficacy Scale is correlated to emotion, optimism, work, satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout, and anxiety. Scoring: Not at all true, Hardly true, Moderately true, Exactly true, All questions 1 2 3 4. The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.

Change from base-line scores GSE scale at 6 months
General Self-Efficacy Scale (GSE)
大体时间:Change from base-line scores GSE scale at 12 months

The General Self-Efficacy Scale is correlated to emotion, optimism, work, satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout, and anxiety. Scoring: Not at all true, Hardly true, Moderately true, Exactly true, All questions 1 2 3 4. The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.

Change from base-line scores GSE scale at 12 months
General Self-Efficacy Scale (GSE)
大体时间:Change from base-line scores GSE scale at 24 months

The General Self-Efficacy Scale is correlated to emotion, optimism, work, satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout, and anxiety. Scoring: Not at all true, Hardly true, Moderately true, Exactly true, All questions 1 2 3 4. The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.

Change from base-line scores GSE scale at 24 months
General Self-Efficacy Scale (GSE)
大体时间:Change from base-line scores GSE scale at 36 months

The General Self-Efficacy Scale is correlated to emotion, optimism, work, satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout, and anxiety. Scoring: Not at all true, Hardly true, Moderately true, Exactly true, All questions 1 2 3 4. The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.

Change from base-line scores GSE scale at 36 months
The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
大体时间:Change from base-line scores HLSE-EU-Q16 scale at 3 months

The HLS-EU-Q16, or the Health Literacy Survey European Questionnaire (short version with 16 questions), is a standardized tool designed to measure health literacy in populations. Health literacy refers to an individual's ability to access, understand, appraise, and apply information to make informed decisions regarding their health. Each question in the HLS-EU-Q16 is answered on a Likert scale with four response options: Very difficult (1 point), Fairly difficult (2 points), Fairly easy (3 points), Very easy (4 points). To calculate the total score, sum the points for all 16 questions. The total score can range from 16 to 64 points. Low points are Inadequate Health Literacy.

Change from base-line scores HLSE-EU-Q16 scale at 3 months
The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
大体时间:Change from base-line scores HLSE-EU-Q16 scale at 6 months

The HLS-EU-Q16, or the Health Literacy Survey European Questionnaire (short version with 16 questions), is a standardized tool designed to measure health literacy in populations. Health literacy refers to an individual's ability to access, understand, appraise, and apply information to make informed decisions regarding their health. Each question in the HLS-EU-Q16 is answered on a Likert scale with four response options: Very difficult (1 point), Fairly difficult (2 points), Fairly easy (3 points), Very easy (4 points). To calculate the total score, sum the points for all 16 questions. The total score can range from 16 to 64 points. Low points are Inadequate Health Literacy.

Change from base-line scores HLSE-EU-Q16 scale at 6 months
The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
大体时间:Change from base-line scores HLSE-EU-Q16 scale at 12 months

The HLS-EU-Q16, or the Health Literacy Survey European Questionnaire (short version with 16 questions), is a standardized tool designed to measure health literacy in populations. Health literacy refers to an individual's ability to access, understand, appraise, and apply information to make informed decisions regarding their health. Each question in the HLS-EU-Q16 is answered on a Likert scale with four response options: Very difficult (1 point), Fairly difficult (2 points), Fairly easy (3 points), Very easy (4 points). To calculate the total score, sum the points for all 16 questions. The total score can range from 16 to 64 points. Low points are Inadequate Health Literacy.

Change from base-line scores HLSE-EU-Q16 scale at 12 months
The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
大体时间:Change from base-line scores HLSE-EU-Q16 scale at 24 months

The HLS-EU-Q16, or the Health Literacy Survey European Questionnaire (short version with 16 questions), is a standardized tool designed to measure health literacy in populations. Health literacy refers to an individual's ability to access, understand, appraise, and apply information to make informed decisions regarding their health. Each question in the HLS-EU-Q16 is answered on a Likert scale with four response options: Very difficult (1 point), Fairly difficult (2 points), Fairly easy (3 points), Very easy (4 points). To calculate the total score, sum the points for all 16 questions. The total score can range from 16 to 64 points. Low points are Inadequate Health Literacy.

Change from base-line scores HLSE-EU-Q16 scale at 24 months
The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
大体时间:Change from base-line scores HLSE-EU-Q16 scale at 36 months

The HLS-EU-Q16, or the Health Literacy Survey European Questionnaire (short version with 16 questions), is a standardized tool designed to measure health literacy in populations. Health literacy refers to an individual's ability to access, understand, appraise, and apply information to make informed decisions regarding their health. Each question in the HLS-EU-Q16 is answered on a Likert scale with four response options: Very difficult (1 point), Fairly difficult (2 points), Fairly easy (3 points), Very easy (4 points). To calculate the total score, sum the points for all 16 questions. The total score can range from 16 to 64 points. Low points are Inadequate Health Literacy.

Change from base-line scores HLSE-EU-Q16 scale at 36 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Dominique Hange, Ass Prof、Göteborg University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年9月1日

初级完成 (估计的)

2026年9月1日

研究完成 (估计的)

2029年6月1日

研究注册日期

首次提交

2024年7月31日

首先提交符合 QC 标准的

2024年7月31日

首次发布 (实际的)

2024年8月5日

研究记录更新

最后更新发布 (实际的)

2026年9月22日

上次提交的符合 QC 标准的更新

2026年9月21日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • iCBT-Senior-DEP-2024-PRCT

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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