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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Hospital Miguel Servet.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Javier Garcia Campayo, Hospital Miguel Servet
ClinicalTrials.gov Identifier:
NCT01611818
First received: May 23, 2012
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Depression
Other: Low Intensity Internet-delivered psychotherapy
Other: Self-guided Internet delivered psychotherapy
Other: Improved treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Low Intensity Versus Self-guided Internet-delivered Psychotherapy for Major Depression: a Multicenter, Controlled, Randomised Study

Resource links provided by NLM:


Further study details as provided by Hospital Miguel Servet:

Primary Outcome Measures:
  • Severity of depressive symptomatology measured by Beck Depression Inventory II [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Socio-demographic variables. [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 450
Study Start Date: September 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Low intensity Internet-delivered psychotherapy
Low intensity Internet-delivered psychotherapy + improved treatment as usual by GP.
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
Self-guided Internet-delivered psychotherapy + improved treatment as usual
Other: Self-guided Internet delivered psychotherapy
No contact with the therapists over the treatment period will be done.
Improved treatment as usual by GP Other: Improved treatment as usual
Any kind of treatment administered by the GP to the patient with depression

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611818

Contacts
Contact: Javier García, MD +34976765500 jgarcamp@gmail.com

Locations
Spain
Hospital Parc Sanitari Sant Joan de Deu Active, not recruiting
Sant Boi de Llobregat, Barcelona, Spain, 08830
Health Science Research Institute, University Balearic Islands Active, not recruiting
Palma de Mallorca, Mallorca, Spain
Psychiatric Service. Hospital Vall D'Hebrón Active, not recruiting
Barcelona, Spain, 08035
Psychiatric Service. University Hospital Carlos Haya
Málaga, Spain, 29010
Valencia University and CIBER Physiopathology of Obesity and Nutrition. Carlos III Health Institute Active, not recruiting
Valencia, Spain
Department of Psychiatry. Miguel Servet University Hospital Active, not recruiting
Zaragoza, Spain, 50009
Sponsors and Collaborators
Javier Garcia Campayo
Carlos III Health Institute
Investigators
Principal Investigator: Javier García Campayo, PhD Miguel Servet Hospital & University of Zaragoza, Spain
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Javier Garcia Campayo, Principal Investigator, Hospital Miguel Servet
ClinicalTrials.gov Identifier: NCT01611818     History of Changes
Other Study ID Numbers: PI10/01083
Study First Received: May 23, 2012
Last Updated: May 31, 2012
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Miguel Servet:
Depression
Computer-delivered psychotherapy
Randomized-controlled trial

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014