Actively Recruiting
The New Internet Generation: iCBT Treatment for Seniors With Mild-moderate Depression - a Pragmatic Randomised Controlled Trial in the Primary Care Context
Led by Göteborg University · Updated on 2025-04-01
390
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
G
Göteborg University
Lead Sponsor
V
Vastra Gotaland Region
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating internet cognitive behavioural therapy (iCBT) for older adults over 65 years with mild to moderate depression in primary care settings. This study compares iCBT with the usual depression treatments provided at primary care centres, aiming to see if iCBT can reduce depressive symptoms, improve quality of life, and increase daily functioning over a period of 36 months. Participants will be randomly assigned to either the iCBT program or treatment as usual (TAU). The iCBT program lasts 10 to 12 weeks, with weekly therapist or nurse contact via email or phone. The control group receives standard depression care according to Swedish guidelines, which may include self-help, face-to-face therapy (excluding iCBT), or antidepressant medication. The study design reflects typical primary care practice to ensure real-world applicability. During the study, participants will be followed up at 3, 6, 12, 24, and 36 months to assess changes in depressive symptoms, quality of life, work ability, daily functioning, and social participation. Assessments include standardized questionnaires such as the Montgomery and Asberg Depression Rating Scale (MADRS-S) and the EQ-5D quality of life scale. Focus group interviews with patients and staff will explore experiences with iCBT. The total participation time may last up to three years with regular evaluations throughout.
CONDITIONS
Brief Title
iCBT for Seniors With Depression in Primary Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged over 65 attending participating primary care centres
- Patients with mild or moderate depressive symptoms diagnosed by standard guidelines
- Diagnosis confirmed by Mini International Neuropsychiatric Interview (M.I.N.I.) by trained staff
- Patients willing to participate and able to have a general practitioner somatic consultation
- Patients able to understand and speak Swedish
You will not qualify if you...
- Patients with severe depression
- Patients with prior suicide attempts or medium to high suicide risk
- Patients diagnosed with bipolar disorder
- Patients diagnosed with psychosis
- Patients with addiction problems
- Patients with cognitive impairment
- Patients unable to speak or understand Swedish
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 to 12 weeks
Participants receive an internet-based cognitive behavioral therapy (iCBT) program for depression with minimal therapist contact. The program includes weekly contact via email or telephone with a therapist or nurse.
Weekly contact via email or telephone
Duration - Up to 36 months
Participants are followed up to assess depression symptoms, quality of life, work ability, social participation, and other outcomes over time.
Follow-up assessments at 3, 6, 12, 24, and 36 months
Trial Site Locations
Total: 1 location
1
University of Gothenburg
Gothenburg, Sweden
Actively Recruiting
Research Team
D
Dominique Hange, Ass Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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