iCBT for Seniors With Depression in Primary Care

NCT ID: NCT06537869

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2029-06-30

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.

Conditions

Depression Mild; Depression Moderate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

iCBT Senior

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)

Group Type: EXPERIMENTAL

iCBT for depression

Intervention Type: BEHAVIORAL

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)

Depression treatment-as-usual Senior

Depression treatment-as-usual for patient \>65 years

Group Type: ACTIVE_COMPARATOR

iCBT for depression

Intervention Type: BEHAVIORAL

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)

Interventions

iCBT for depression

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)

Intervention Type: BEHAVIORAL

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.

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominique Hange, Ass Prof

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

University of Gothenburg

Gothenburg, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Dominique Hange, Ass Prof

Role: CONTACT

dominique.hange@allmed.gu.se

+46722 245 700

Facility Contacts

Dominique Hange

Role: primary

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

iCBT-Senior-DEP-2024-PRCT

Identifier Type: -

Identifier Source: org_study_id