Depression MildNCT06537869
iCBT for Seniors With Depression in Primary Care
A study testing iCBT for depression in people with Depression Mild and Depression Moderate, run by Göteborg University at 1 site in Sweden.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depression Mild, Depression Moderate
- What is being tested?
- iCBT for depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2024to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The New Internet Generation: iCBT Treatment for Seniors With Mild-moderate Depression - a Pragmatic Randomised Controlled Trial in the Primary Care Context
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Depression Mild, Depression Moderate
- Being tested
- iCBT for depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCBT for depressionBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| iCBT Senior | Experimental | 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) Receives: Behavioral: iCBT for depression |
| Depression treatment-as-usual Senior | Active comparator | Depression treatment-as-usual for patient >65 years Receives: Behavioral: iCBT for depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS-S (Montgomery and Asberg Depression Rating Scale)
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
Measured: Change from baseline scores MADRS-S scale at 3 months
MADRS-S (Montgomery and Asberg Depression Rating Scale)
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
Measured: Change from baseline scores MADRS-S scale at 6 months
MADRS-S (Montgomery and Asberg Depression Rating Scale)
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
Measured: Change from baseline scores MADRS-S scale at 12 months
MADRS-S (Montgomery and Asberg Depression Rating Scale)
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
Measured: Change from baseline scores MADRS-S scale at 24 months
MADRS-S (Montgomery and Asberg Depression Rating Scale)
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
Measured: Change from baseline scores MADRS-S scale at 36 months
Secondary outcomes (26)
The 5-level EQ-5D version (EQ-5D-5L) EuroQol 5-Dimension
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)?
Measured: Change from baseline scores EQ-5D scale at 3 months
The 5-level EQ-5D version (EQ-5D-5L)
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.
Measured: Change from baseline scores EQ-5D scale at 6 months
The 5-level EQ-5D version (EQ-5D-5L)
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.
Measured: Change from baseline scores EQ-5D scale at 12 months
The 5-level EQ-5D version (EQ-5D-5L)
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.
Measured: Change from baseline scores EQ-5D scale at 24 months
The 5-level EQ-5D version (EQ-5D-5L)
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.
Measured: Change from baseline scores EQ-5D scale at 36 months
Work ability
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).
Measured: Change from baseline scores WAI scale at 3 months
Work ability
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).
Measured: Change from base-line scores WAI scale at 6 months
Work ability
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).
Measured: Change from base-line scores WAI scale at 12 months
Work ability
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).
Measured: Change from base-line scores WAI scale at 24 months
Work ability
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).
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: Change from base-line scores WHODAS scale at 36 months
Use of Antidepressants
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.
Measured: Antidepressant use will be assessed at baseline and after 12 months of participation in the study.
General Self-Efficacy Scale (GSE)
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.
Measured: Change from base-line scores GSE scale at 3 months
General Self-Efficacy Scale (GSE)
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.
Measured: Change from base-line scores GSE scale at 6 months
General Self-Efficacy Scale (GSE)
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.
Measured: Change from base-line scores GSE scale at 12 months
General Self-Efficacy Scale (GSE)
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.
Measured: Change from base-line scores GSE scale at 24 months
General Self-Efficacy Scale (GSE)
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.
Measured: Change from base-line scores GSE scale at 36 months
The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
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.
Measured: Change from base-line scores HLSE-EU-Q16 scale at 3 months
The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
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.
Measured: Change from base-line scores HLSE-EU-Q16 scale at 6 months
The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
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.
Measured: Change from base-line scores HLSE-EU-Q16 scale at 12 months
The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
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.
Measured: Change from base-line scores HLSE-EU-Q16 scale at 24 months
The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
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.
Measured: Change from base-line scores HLSE-EU-Q16 scale at 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Sep 2024
- Primary completionSep 2026 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression MildStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Sponsor
- Investigators
- Dominique Hange, Ass Prof, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537869
- Sponsor's protocol ID
- iCBT-Senior-DEP-2024-PRCT
- Status last verified
- Sep 2026
- First submitted
- 31 Jul 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The New Internet Generation: iCBT Treatment for Seniors With Mild-moderate Depression - a Pragmatic Randomised Controlled Trial in the Primary Care Context
- ClinicalTrials.gov ID
- NCT06537869
- Acronym / sponsor ID
- iCBT-Senior-DEP-2024-PRCT
- Conditions
- Depression Mild, Depression Moderate
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iCBT Senior | Experimental | Behavioral: iCBT for depressioniCBT 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) |
| Depression treatment-as-usual Senior | Active comparator | Behavioral: iCBT for depressionDepression treatment-as-usual for patient >65 years |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCBT for depressioniCBT 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) | Behavioural | Depression treatment-as-usual Senior, iCBT Senior |
Primary outcome
MADRS-S (Montgomery and Asberg Depression Rating Scale)
Time frame: 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
MADRS-S (Montgomery and Asberg Depression Rating Scale)
Time frame: 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
MADRS-S (Montgomery and Asberg Depression Rating Scale)
Time frame: 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
MADRS-S (Montgomery and Asberg Depression Rating Scale)
Time frame: 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
MADRS-S (Montgomery and Asberg Depression Rating Scale)
Time frame: 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
26 secondary outcomes
The 5-level EQ-5D version (EQ-5D-5L) EuroQol 5-Dimension
Time frame: Change from baseline scores EQ-5D scale at 3 months
The 5-level EQ-5D version (EQ-5D-5L)
Time frame: Change from baseline scores EQ-5D scale at 6 months
The 5-level EQ-5D version (EQ-5D-5L)
Time frame: Change from baseline scores EQ-5D scale at 12 months
The 5-level EQ-5D version (EQ-5D-5L)
Time frame: Change from baseline scores EQ-5D scale at 24 months
The 5-level EQ-5D version (EQ-5D-5L)
Time frame: Change from baseline scores EQ-5D scale at 36 months
Work ability
Time frame: Change from baseline scores WAI scale at 3 months
Work ability
Time frame: Change from base-line scores WAI scale at 6 months
Work ability
Time frame: Change from base-line scores WAI scale at 12 months
Work ability
Time frame: Change from base-line scores WAI scale at 24 months
Work ability
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from base-line scores WHODAS scale at 36 months
Use of Antidepressants
Time frame: Antidepressant use will be assessed at baseline and after 12 months of participation in the study.
General Self-Efficacy Scale (GSE)
Time frame: Change from base-line scores GSE scale at 3 months
General Self-Efficacy Scale (GSE)
Time frame: Change from base-line scores GSE scale at 6 months
General Self-Efficacy Scale (GSE)
Time frame: Change from base-line scores GSE scale at 12 months
General Self-Efficacy Scale (GSE)
Time frame: Change from base-line scores GSE scale at 24 months
General Self-Efficacy Scale (GSE)
Time frame: Change from base-line scores GSE scale at 36 months
The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
Time frame: Change from base-line scores HLSE-EU-Q16 scale at 3 months
The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
Time frame: Change from base-line scores HLSE-EU-Q16 scale at 6 months
The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
Time frame: Change from base-line scores HLSE-EU-Q16 scale at 12 months
The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
Time frame: Change from base-line scores HLSE-EU-Q16 scale at 24 months
The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
Time frame: Change from base-line scores HLSE-EU-Q16 scale at 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Hange, Ass Prof principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCBT for depression in people with Depression Mild and Depression Moderate, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MADRS-S (Montgomery and Asberg Depression Rating Scale) (time frame: Change from baseline scores MADRS-S scale at 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.