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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01611818
First Posted: June 5, 2012
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Javier Garcia Campayo, Hospital Miguel Servet
May 23, 2012
June 5, 2012
August 10, 2017
September 2012
December 2014   (Final data collection date for primary outcome measure)
  • Severity of depressive symptomatology measured by Beck Depression Inventory II [ Time Frame: At baseline ]
    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.
  • Severity of depressive symptomatology measured by Beck Depression Inventory II [ Time Frame: After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program. ]
    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.
  • Severity of depressive symptomatology measured by Beck Depression Inventory II [ Time Frame: 3 months after completing the psychotherapy program ]
    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.
  • Severity of depressive symptomatology measured by Beck Depression Inventory II [ Time Frame: 12 months after completing the psychotherapy program ]
    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.
Same as current
Complete list of historical versions of study NCT01611818 on ClinicalTrials.gov Archive Site
  • Socio-demographic variables. [ Time Frame: At Baseline ]
    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€).
  • Mini-International Neuropsychiatric Interview (MINI). [ Time Frame: At Baseline ]
    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.
  • EuroQoL-5D questionnaire (EQ-5D - Spanish version) [ Time Frame: At Baseline ]
    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.
  • Client Service Receipt Inventory - adapted (CSRI - Spanish version) [ Time Frame: At baseline ]
    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.
  • Overall Depression Severity and Impairment Scale [ Time Frame: At baseline ]
    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.
  • Positive and Negative Affect Scale (PANAS) [ Time Frame: At Baseline ]
    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.
  • Credibility/expectancy questionnaire [ Time Frame: At Baseline ]
    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.
  • EuroQoL-5D questionnaire (EQ-5D - Spanish version) [ Time Frame: After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program. ]
    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.
  • EuroQoL-5D questionnaire (EQ-5D - Spanish version) [ Time Frame: 3 months after completing the psychotherapy program ]
    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.
  • EuroQoL-5D questionnaire (EQ-5D - Spanish version) [ Time Frame: 12 months after completing the psychotherapy program ]
    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.
  • Client Service Receipt Inventory - adapted (CSRI - Spanish version) [ Time Frame: After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program ]
    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.
  • Client Service Receipt Inventory - adapted (CSRI - Spanish version) [ Time Frame: 3 months after completing the psychotherapy program ]
    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.
  • Client Service Receipt Inventory - adapted (CSRI - Spanish version) [ Time Frame: 12 months after completing the psychotherapy program ]
    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.
  • Overall Depression Severity and Impairment Scale [ Time Frame: After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program. ]
    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.
  • Overall Depression Severity and Impairment Scale [ Time Frame: 3 months after completing the psychotherapy program ]
    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.
  • Overall Depression Severity and Impairment Scale [ Time Frame: 12 months after completing the psychotherapy program ]
    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.
  • Positive and Negative Affect Scale (PANAS) [ Time Frame: After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program. ]
    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.
  • Positive and Negative Affect Scale (PANAS) [ Time Frame: 3 months after completing the psychotherapy program ]
    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.
  • Positive and Negative Affect Scale (PANAS) [ Time Frame: 12 months after completing the psychotherapy program ]
    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.
Same as current
Not Provided
Not Provided
 
Low Intensity Versus Self-guided Internet-delivered Psychotherapy for Major Depression
Low Intensity Versus Self-guided Internet-delivered Psychotherapy for Major Depression: a Multicenter, Controlled, Randomised Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Depression
  • 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
  • Other: Self-guided Internet delivered psychotherapy
    No contact with the therapists over the treatment period will be done.
  • Other: Improved treatment as usual
    Any kind of treatment administered by the GP to the patient with depression
  • Low intensity Internet-delivered psychotherapy
    Low intensity Internet-delivered psychotherapy + improved treatment as usual by GP.
    Intervention: Other: Low Intensity Internet-delivered psychotherapy
  • Self-guided Internet-delivered psychotherapy
    Self-guided Internet-delivered psychotherapy + improved treatment as usual
    Intervention: Other: Self-guided Internet delivered psychotherapy
  • Improved treatment as usual by GP
    Intervention: Other: Improved treatment as usual

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
December 2016
December 2014   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01611818
PI10/01083
No
Not Provided
Not Provided
Javier Garcia Campayo, Hospital Miguel Servet
Javier Garcia Campayo
Carlos III Health Institute
Principal Investigator: Javier García Campayo, PhD Miguel Servet Hospital & University of Zaragoza, Spain
Hospital Miguel Servet
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP