Clinical trial NCT06537869: iCBT for Seniors With Depression in Primary Care
Official title: The New Internet Generation: iCBT Treatment for Seniors With Mild-moderate Depression - a Pragmatic Randomised Controlled Trial in the Primary Care Context
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression Mild
Depression Moderate
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2024-08-05
Enrollment: 390
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MADRS-S (Montgomery and Asberg Depression Rating Scale)
timeFrame: Change from baseline scores MADRS-S scale at 3 months
measure: MADRS-S (Montgomery and Asberg Depression Rating Scale)
timeFrame: Change from baseline scores MADRS-S scale at 6 months
measure: MADRS-S (Montgomery and Asberg Depression Rating Scale)
timeFrame: Change from baseline scores MADRS-S scale at 12 months
measure: MADRS-S (Montgomery and Asberg Depression Rating Scale)
timeFrame: Change from baseline scores MADRS-S scale at 24 months
measure: MADRS-S (Montgomery and Asberg Depression Rating Scale)
timeFrame: Change from baseline scores MADRS-S scale at 36 months
Secondary outcomes:
measure: The 5-level EQ-5D version (EQ-5D-5L) EuroQol 5-Dimension
timeFrame: Change from baseline scores EQ-5D scale at 3 months
measure: The 5-level EQ-5D version (EQ-5D-5L)
timeFrame: Change from baseline scores EQ-5D scale at 6 months
measure: The 5-level EQ-5D version (EQ-5D-5L)
timeFrame: Change from baseline scores EQ-5D scale at 12 months
measure: The 5-level EQ-5D version (EQ-5D-5L)
timeFrame: Change from baseline scores EQ-5D scale at 24 months
measure: The 5-level EQ-5D version (EQ-5D-5L)
timeFrame: Change from baseline scores EQ-5D scale at 36 months
measure: Work ability
timeFrame: Change from baseline scores WAI scale at 3 months
measure: Work ability
timeFrame: Change from base-line scores WAI scale at 6 months
measure: Work ability
timeFrame: Change from base-line scores WAI scale at 12 months
measure: Work ability
timeFrame: Change from base-line scores WAI scale at 24 months
measure: Work ability
timeFrame: Change from base-line scores WAI scale at 36 months
measure: WHODAS 12 2.0 (WORLD HEALTH ORGANIZATION DISABILITY ASSESSMENT SCHEDULE 2.0), 12-item version, self-administered
timeFrame: Change from base-line scores WHODAS scale at 3 months
measure: WHODAS 12 2.0 (WORLD HEALTH ORGANIZATION DISABILITY ASSESSMENT SCHEDULE 2.0), 12-item version, self-administered
timeFrame: Change from base-line scores WHODAS scale at 6 months
measure: WHODAS 12 2.0 (WORLD HEALTH ORGANIZATION DISABILITY ASSESSMENT SCHEDULE 2.0), 12-item version, self-administered
timeFrame: Change from base-line scores WHODAS scale at 12 months
measure: WHODAS 12 2.0 (WORLD HEALTH ORGANIZATION DISABILITY ASSESSMENT SCHEDULE 2.0), 12-item version, self-administered
timeFrame: Change from base-line scores WHODAS scale at 24 months
measure: WHODAS 12 2.0 (WORLD HEALTH ORGANIZATION DISABILITY ASSESSMENT SCHEDULE 2.0), 12-item version, self-administered
timeFrame: Change from base-line scores WHODAS scale at 36 months
measure: Use of Antidepressants
timeFrame: Antidepressant use will be assessed at baseline and after 12 months of participation in the study.
measure: General Self-Efficacy Scale (GSE)
timeFrame: Change from base-line scores GSE scale at 3 months
measure: General Self-Efficacy Scale (GSE)
timeFrame: Change from base-line scores GSE scale at 6 months
measure: General Self-Efficacy Scale (GSE)
timeFrame: Change from base-line scores GSE scale at 12 months
measure: General Self-Efficacy Scale (GSE)
timeFrame: Change from base-line scores GSE scale at 24 months
measure: General Self-Efficacy Scale (GSE)
timeFrame: Change from base-line scores GSE scale at 36 months
measure: The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
timeFrame: Change from base-line scores HLSE-EU-Q16 scale at 3 months
measure: The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
timeFrame: Change from base-line scores HLSE-EU-Q16 scale at 6 months
measure: The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
timeFrame: Change from base-line scores HLSE-EU-Q16 scale at 12 months
measure: The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
timeFrame: Change from base-line scores HLSE-EU-Q16 scale at 24 months
measure: The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
timeFrame: Change from base-line scores HLSE-EU-Q16 scale at 36 months
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: University of Gothenburg
Study officials:
affiliation: Göteborg University
name: Dominique Hange, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References: