iCBT for Seniors With Depression in Primary Care
NCT Number: NCT06537869
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression Mild|Depression Moderate
Interventions: BEHAVIORAL: iCBT for depression
Sponsor: Göteborg University
Collaborators: Vastra Gotaland Region
Sex: ALL
Age: OLDER_ADULT
Enrollment: 390
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2029-06

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).

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.

Primary Outcome Measures: 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, 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, 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, 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, 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, Change from baseline scores MADRS-S scale at 36 months
Secondary Outcome Measures: 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)?, 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., 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., 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., 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., 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)., 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)., 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)., 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)., 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)., 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, 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, 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, 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, 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, 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., Change from base-line scores HLSE-EU-Q16 scale at 36 months