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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Other: Low Intensity Internet-delivered psychotherapy; Other: Self-guided Internet delivered psychotherapy; Other: Improved treatment as usual

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Psychiatric Service. Hospital Vall D'Hebrón
  • Málaga, Spain, 29010
    • Psychiatric Service. University Hospital Carlos Haya
  • Valencia, Spain
    • Valencia University and CIBER Physiopathology of Obesity and Nutrition. Carlos III Health Institute
  • Zaragoza, Spain, 50009
    • Department of Psychiatry. Miguel Servet University Hospital
  • Barcelona
    • Sant Boi de Llobregat, Barcelona, Spain, 08830
      • Hospital Parc Sanitari Sant Joan de Deu
  • Mallorca
    • Palma de Mallorca, Mallorca, Spain
      • Health Science Research Institute, University Balearic Islands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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.
Other: Improved treatment as usual by GP	Other: Improved treatment as usual; Any kind of treatment administered by the GP to the patient with depression

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Javier Garcia Campayo
• Collaborators: Carlos III Health Institute
• Investigators: Principal Investigator: Javier García Campayo, PhD, Miguel Servet Hospital & University of Zaragoza, Spain

Publications and helpful links

General Publications

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Helpful Links

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

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 23, 2012
• First Submitted That Met QC Criteria: May 31, 2012
• First Posted (Estimate): June 5, 2012

Study Record Updates

• Last Update Posted (Actual): August 10, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Computer-delivered psychotherapy; Randomized-controlled trial
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: PI10/01083