The New Internet Generation: iCBT Treatment for Seniors With Mild-moderate Depression - a Pragmatic Randomised Controlled Trial in the Primary Care Context
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression Mild
- Sponsor
- Göteborg University
- Enrollment
- 390
- Locations
- 1
- Primary Endpoint
- MADRS-S (Montgomery and Asberg Depression Rating Scale)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
MADRS-S (Montgomery and Asberg Depression Rating Scale)
Time Frame: Change from baseline scores MADRS-S scale at 36 months
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
Secondary Outcomes
- The 5-level EQ-5D version (EQ-5D-5L) EuroQol 5-Dimension(Change from baseline scores EQ-5D scale at 3 months)
- WHODAS 12 2.0 (WORLD HEALTH ORGANIZATION DISABILITY ASSESSMENT SCHEDULE 2.0), 12-item version, self-administered(Change from base-line scores WHODAS scale at 36 months)
- The 5-level EQ-5D version (EQ-5D-5L)(Change from baseline scores EQ-5D scale at 36 months)
- Work ability(Change from base-line scores WAI scale at 36 months)
- General Self-Efficacy Scale (GSE)(Change from base-line scores GSE scale at 36 months)
- The Health Literacy Survey European Questionnaire (HLS-EU-Q16)(Change from base-line scores HLSE-EU-Q16 scale at 36 months)
- Use of Antidepressants(Antidepressant use will be assessed at baseline and after 12 months of participation in the study.)