Depression Clinical Trial
Official title:
Low Intensity Versus Self-guided Internet-delivered Psychotherapy for Major Depression: a Multicenter, Controlled, Randomised Study
Verified date | August 2017 |
Source | Hospital Miguel Servet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
BACKGROUND: Major depression will become the second most important cause of disability in
2020. Computerised cognitive-behaviour therapy could be an efficacious and cost-effective
option for its treatment. No studies on cost-effectiveness of low intensity vs self-guided
psychotherapy have been carried out.
AIM: To assess the efficacy of low intensity vs self-guided psychotherapy for major
depression in the Spanish health system.
METHODS: The study is made up of 3 phases: 1.- Development of a computerised
cognitive-behaviour therapy for depression tailored to Spanish health system. 2.- Multicenter
controlled, randomized study: A sample (N=450 patients) with mild/moderate depression
recruited in primary care. They should have internet availability at home, not receive any
previous psychological treatment, and not suffer from any other severe somatic or
psychological disorder. They will be allocated to one of 3 treatments: a) Low intensity
Internet-delivered psychotherapy + improved treatment as usual (ITAU) by GP, b) Self-guided
Internet-delivered psychotherapy + ITAU or c) ITAU. Patients will be diagnosed with MINI
psychiatric interview. Main outcome variable will be Beck Depression Inventory. It will be
also administered EuroQol 5D (quality of life) and Client Service Receipt Inventory (consume
of health and social services). Patients will be assessed at baseline, 3 and 12 months. An
intention to treat and a per protocol analysis will be performed.
Status | Completed |
Enrollment | 300 |
Est. completion date | December 2016 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of major depression. It will be carried out with MINI International Neuropsychiatric Interview + scoring of moderate or mild depression using Beck Depression Inventory II. Cut-off point for this questionnaire is: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression [34, 35]. - Aged 18-65 years - Able to understand and read Spanish - Moderate or mild major depression - Duration of symptoms longer than 2 weeks - Access to Internet at home and having an email address. Exclusion Criteria: - Any psychological treatment during last year - Severe psychiatric disorder in Axis I (alcohol/substances abuse or dependence, psychotic disorders or dementia)patients with severe depression (indicated by a Beck-II score of 29 or higher) who will be advised to consult their GP Receiving pharmacological treatment with antidepressants is not an exclusion criteria meanwhile, during the study period, treatment will not be modified or increased (decrease of pharmacological treatment is accepted). |
Country | Name | City | State |
---|---|---|---|
Spain | Psychiatric Service. Hospital Vall D'Hebrón | Barcelona | |
Spain | Psychiatric Service. University Hospital Carlos Haya | Málaga | |
Spain | Health Science Research Institute, University Balearic Islands | Palma de Mallorca | Mallorca |
Spain | Hospital Parc Sanitari Sant Joan de Deu | Sant Boi de Llobregat | Barcelona |
Spain | Valencia University and CIBER Physiopathology of Obesity and Nutrition. Carlos III Health Institute | Valencia | |
Spain | Department of Psychiatry. Miguel Servet University Hospital | Zaragoza |
Lead Sponsor | Collaborator |
---|---|
Javier Garcia Campayo | Carlos III Health Institute |
Spain,
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* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severity of depressive symptomatology measured by Beck Depression Inventory II | This is one of the most widely questionnaires used to evaluate severity of depression in pharmacological and psychotherapy trials. This questionnaire has been used because it is recommended to assess depression in primary care patients in which comorbidity with medical disorders is frequent. The Spanish validated version of the questionnaire will be used. | At baseline | |
Primary | Severity of depressive symptomatology measured by Beck Depression Inventory II | This is one of the most widely questionnaires used to evaluate severity of depression in pharmacological and psychotherapy trials. This questionnaire has been used because it is recommended to assess depression in primary care patients in which comorbidity with medical disorders is frequent. The Spanish validated version of the questionnaire will be used. | After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program. | |
Primary | Severity of depressive symptomatology measured by Beck Depression Inventory II | This is one of the most widely questionnaires used to evaluate severity of depression in pharmacological and psychotherapy trials. This questionnaire has been used because it is recommended to assess depression in primary care patients in which comorbidity with medical disorders is frequent. The Spanish validated version of the questionnaire will be used. | 3 months after completing the psychotherapy program | |
Primary | Severity of depressive symptomatology measured by Beck Depression Inventory II | This is one of the most widely questionnaires used to evaluate severity of depression in pharmacological and psychotherapy trials. This questionnaire has been used because it is recommended to assess depression in primary care patients in which comorbidity with medical disorders is frequent. The Spanish validated version of the questionnaire will be used. | 12 months after completing the psychotherapy program | |
Secondary | Socio-demographic variables. | The following socio-demographic data will be collected: gender, age, marital status (single, married/relationship, separated/divorced, and widowed), education (years of education), occupation, economical level (in relation with Spanish minimum monthly salary that at the moment of the study was 640€). | At Baseline | |
Secondary | Mini-International Neuropsychiatric Interview (MINI). | This is a short structured diagnostic psychiatric interview that yields key DSM-IV and ICD-10 diagnoses. MINI can be administered in a short period of time and clinical interviewers need only a brief training. The MINI has been translated and validated in Spanish. | At Baseline | |
Secondary | EuroQoL-5D questionnaire (EQ-5D - Spanish version) | Generic instrument of health-related quality of life. It has two parts: part 1 records self-reported problems in each of five domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain is divided into three levels of severity corresponding to no problems, some problems, and extreme problems. Values range from 1 (best health state) to 0 (death). Part 2 records the subject's self-assessed health on a VAS, a 10 cm vertical line on which the best and worst imaginable health states score 100 and 0, respectively. | At Baseline | |
Secondary | Client Service Receipt Inventory - adapted (CSRI - Spanish version) | Questionnaire for collecting information about use of healthcare and social care services and other economic impacts (such as time off work due to illness). The variant used in this study was designed to collect retrospective data on service utilization during the previous months after the last assessment. Data on baseline assess the previous three months before inclusion. | At baseline | |
Secondary | Overall Depression Severity and Impairment Scale | OASIS consists of 5 items that measure the frequency and severity of anxiety, as well as level of avoidance, work/ school/home interference, and social interference associated with anxiety. The instructions orient the respondent to considerate wide range of anxiety symptoms (e.g., panic attacks, worries, flashbacks) when answering the questions, and the time frame is "over the past week". Respondents select among five different response options for each item, which are coded 0-4 and summed to obtain a total score. | At baseline | |
Secondary | Positive and Negative Affect Scale (PANAS) | PANAS consists of 20 items that evaluate two independent dimensions: positive affect (PA) and negative affect (NA). The range for each scale (10 items on each) is 10 to 50. The instrument's psychometric properties are quite satisfactory. It has a validated Spanish version. | At Baseline | |
Secondary | Credibility/expectancy questionnaire | It is a quick and easy-to-administer scale for assessing treatment expectancy and rationale credibility. Credibility has been defined as how believable, convincing, and logical the treatment is, whereas expectancy refers to improvements that clients believe will be achieved. The aspects that address these two scales relate to: 1) treatment rationale, 2) treatment satisfaction, 3) degree to which I would recommend to a friend who had the same problem, 4) extent to which is considered to be useful in the same case, 6) extent to which the intervention would be considered aversive. | At Baseline | |
Secondary | EuroQoL-5D questionnaire (EQ-5D - Spanish version) | Generic instrument of health-related quality of life. It has two parts: part 1 records self-reported problems in each of five domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain is divided into three levels of severity corresponding to no problems, some problems, and extreme problems. Values range from 1 (best health state) to 0 (death). Part 2 records the subject's self-assessed health on a VAS, a 10 cm vertical line on which the best and worst imaginable health states score 100 and 0, respectively. | After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program. | |
Secondary | EuroQoL-5D questionnaire (EQ-5D - Spanish version) | Generic instrument of health-related quality of life. It has two parts: part 1 records self-reported problems in each of five domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain is divided into three levels of severity corresponding to no problems, some problems, and extreme problems. Values range from 1 (best health state) to 0 (death). Part 2 records the subject's self-assessed health on a VAS, a 10 cm vertical line on which the best and worst imaginable health states score 100 and 0, respectively. | 3 months after completing the psychotherapy program | |
Secondary | EuroQoL-5D questionnaire (EQ-5D - Spanish version) | Generic instrument of health-related quality of life. It has two parts: part 1 records self-reported problems in each of five domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain is divided into three levels of severity corresponding to no problems, some problems, and extreme problems. Values range from 1 (best health state) to 0 (death). Part 2 records the subject's self-assessed health on a VAS, a 10 cm vertical line on which the best and worst imaginable health states score 100 and 0, respectively. | 12 months after completing the psychotherapy program | |
Secondary | Client Service Receipt Inventory - adapted (CSRI - Spanish version) | Questionnaire for collecting information about use of healthcare and social care services and other economic impacts (such as time off work due to illness). The variant used in this study was designed to collect retrospective data on service utilization during the previous months after the last assessment. Data on baseline assess the previous three months before inclusion. | After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program | |
Secondary | Client Service Receipt Inventory - adapted (CSRI - Spanish version) | Questionnaire for collecting information about use of healthcare and social care services and other economic impacts (such as time off work due to illness). The variant used in this study was designed to collect retrospective data on service utilization during the previous months after the last assessment. Data on baseline assess the previous three months before inclusion. | 3 months after completing the psychotherapy program | |
Secondary | Client Service Receipt Inventory - adapted (CSRI - Spanish version) | Questionnaire for collecting information about use of healthcare and social care services and other economic impacts (such as time off work due to illness). The variant used in this study was designed to collect retrospective data on service utilization during the previous months after the last assessment. Data on baseline assess the previous three months before inclusion. | 12 months after completing the psychotherapy program | |
Secondary | Overall Depression Severity and Impairment Scale | OASIS consists of 5 items that measure the frequency and severity of anxiety, as well as level of avoidance, work/ school/home interference, and social interference associated with anxiety. The instructions orient the respondent to considerate wide range of anxiety symptoms (e.g., panic attacks, worries, flashbacks) when answering the questions, and the time frame is "over the past week". Respondents select among five different response options for each item, which are coded 0-4 and summed to obtain a total score. | After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program. | |
Secondary | Overall Depression Severity and Impairment Scale | OASIS consists of 5 items that measure the frequency and severity of anxiety, as well as level of avoidance, work/ school/home interference, and social interference associated with anxiety. The instructions orient the respondent to considerate wide range of anxiety symptoms (e.g., panic attacks, worries, flashbacks) when answering the questions, and the time frame is "over the past week". Respondents select among five different response options for each item, which are coded 0-4 and summed to obtain a total score. | 3 months after completing the psychotherapy program | |
Secondary | Overall Depression Severity and Impairment Scale | OASIS consists of 5 items that measure the frequency and severity of anxiety, as well as level of avoidance, work/ school/home interference, and social interference associated with anxiety. The instructions orient the respondent to considerate wide range of anxiety symptoms (e.g., panic attacks, worries, flashbacks) when answering the questions, and the time frame is "over the past week". Respondents select among five different response options for each item, which are coded 0-4 and summed to obtain a total score. | 12 months after completing the psychotherapy program | |
Secondary | Positive and Negative Affect Scale (PANAS) | PANAS consists of 20 items that evaluate two independent dimensions: positive affect (PA) and negative affect (NA). The range for each scale (10 items on each) is 10 to 50. The instrument's psychometric properties are quite satisfactory. It has a validated Spanish version. | After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program. | |
Secondary | Positive and Negative Affect Scale (PANAS) | PANAS consists of 20 items that evaluate two independent dimensions: positive affect (PA) and negative affect (NA). The range for each scale (10 items on each) is 10 to 50. The instrument's psychometric properties are quite satisfactory. It has a validated Spanish version. | 3 months after completing the psychotherapy program | |
Secondary | Positive and Negative Affect Scale (PANAS) | PANAS consists of 20 items that evaluate two independent dimensions: positive affect (PA) and negative affect (NA). The range for each scale (10 items on each) is 10 to 50. The instrument's psychometric properties are quite satisfactory. It has a validated Spanish version. | 12 months after completing the psychotherapy program |
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