iCBT for Seniors With Depression in Primary Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorGöteborg University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
iCBT for depression
BehavioraliCBT 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)
Treatment groups
390 Participants
are divided into 2 treatment groupsGroup A: iCBT SeniorExperimental treatment 1 intervention
Group B: Depression treatment-as-usual SeniorActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Change from baseline scores MADRS-S scale at 3 months2
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
Time frame
Change from baseline scores MADRS-S scale at 6 months3
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
Time frame
Change from baseline scores MADRS-S scale at 12 months4
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
Time frame
Change from baseline scores MADRS-S scale at 24 monthsSecondary outcomes
1
The 5-level EQ-5D version (EQ-5D-5L) EuroQol 5-Dimension
Scale Title: EQ-5D-5L. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. 1 = no difficulties and 5 = very large difficulties. These single-digit codes can be combined into a five-digit code that corresponds to a specific health profile. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. What is the effect of iCBT on participants' health-related quality of life (measured by the change in scores in EQ-5D from baseline to 3 months after baseline)?
Time frame
Change from baseline scores EQ-5D scale at 3 months2
The 5-level EQ-5D version (EQ-5D-5L)
What is the effect of iCBT on participants' health-related quality of life (measured by the change in scores in EQ-5D from baseline to 6 months after baseline? The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time frame
Change from baseline scores EQ-5D scale at 6 months3
The 5-level EQ-5D version (EQ-5D-5L)
What is the effect of iCBT on participants' health-related quality of life (measured by the change in scores in EQ-5D from baseline to 12 months after baseline? The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time frame
Change from baseline scores EQ-5D scale at 12 months4
The 5-level EQ-5D version (EQ-5D-5L)
What is the effect of iCBT on participants' health-related quality of life (measured by the change in scores in EQ-5D from baseline to 24 months after baseline? The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time frame
Change from baseline scores EQ-5D scale at 24 monthsSponsors and contacts
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Göteborg University
Lead sponsor
Vastra Gotaland Region
Collaborator
Source ClinicalTrials.gov