iCBT for Seniors With Depression in Primary Care

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.

• 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]