iCBT for Seniors With Depression in Primary Care

NCT06537869 | Recruiting

• 1 other identifier: iCBT-Senior-DEP-2024-PRCT
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression Mild; Depression Moderate

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (26)

• The 5-level EQ-5D version (EQ-5D-5L) EuroQol 5-Dimension

  Change from baseline scores EQ-5D scale at 3 months

• The 5-level EQ-5D version (EQ-5D-5L)

  Change from baseline scores EQ-5D scale at 6 months

• The 5-level EQ-5D version (EQ-5D-5L)

  Change from baseline scores EQ-5D scale at 12 months

• The 5-level EQ-5D version (EQ-5D-5L)

  Change from baseline scores EQ-5D scale at 24 months

• The 5-level EQ-5D version (EQ-5D-5L)

  Change from baseline scores EQ-5D scale at 36 months

Study Arms (2)

iCBT Senior

EXPERIMENTAL

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)

Behavioral: iCBT for depression

Depression treatment-as-usual Senior

ACTIVE COMPARATOR

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

Behavioral: iCBT for depression

Interventions

iCBT for depression 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; iCBT Senior

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead
• Vastra Gotaland Region: collaborator

Study Sites (1)

University of Gothenburg

Gothenburg, Sweden

RECRUITING

Study Officials

• Dominique Hange, Ass Prof

  Göteborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique Hange, Ass Prof

CONTACT

+46722 245 700; dominique.hange@allmed.gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)