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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611818
• Other study ID #: PI10/01083
• Status: Completed
• Phase: N/A
• First received: May 23, 2012
• Last updated: August 8, 2017
• Start date: September 2012
• Est. completion date: December 2016

Study information

• Verified date: August 2017
• Source: Hospital Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Other:
• Low Intensity Internet-delivered psychotherapy
Patients will be contacted by a researcher trained in psychotherapy. Patients can ask for questions or advice to psychotherapists during the study
• Self-guided Internet delivered psychotherapy
No contact with the therapists over the treatment period will be done.
• Improved treatment as usual
Any kind of treatment administered by the GP to the patient with depression

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Javier Garcia Campayo	Carlos III Health Institute

Country where clinical trial is conducted

Spain, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

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

External Links

•   Official website of the Spanish Research Network in Primary Care (Rediapp)