Low Intensity Versus Self-guided Internet-delivered Psychotherapy for Major Depression

Study Overview
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Brief Summary
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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.

Official Title
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Low Intensity Versus Self-guided Internet-delivered Psychotherapy for Major Depression: a Multicenter, Controlled, Randomised Study

Conditions
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Depression

Intervention / Treatment
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* Other: Low Intensity Internet-delivered psychotherapy
* Other: Self-guided Internet delivered psychotherapy
* Other: Improved treatment as usual


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Low intensity Internet-delivered psychotherapy<br>Low intensity Internet-delivered psychotherapy + improved treatment as usual by GP. | Other: Low Intensity Internet-delivered psychotherapy<br>* Patients will be contacted by a researcher trained in psychotherapy. Patients can ask for questions or advice to psychotherapists during the study<br>|
| Other: Self-guided Internet-delivered psychotherapy<br>Self-guided Internet-delivered psychotherapy + improved treatment as usual | Other: Self-guided Internet delivered psychotherapy<br>* No contact with the therapists over the treatment period will be done.<br>|
| Other: Improved treatment as usual by GP<br> | Other: Improved treatment as usual<br>* Any kind of treatment administered by the GP to the patient with depression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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. | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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. | 
| 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 | 
| 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 | 
| 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. | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Computer-delivered psychotherapy, Randomized-controlled trial