DepressionNCT01611818

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

A study testing Low Intensity Internet-delivered psychotherapy, Self-guided Internet delivered psychotherapy and Improved treatment as usual in people with Depression, run by Javier Garcia Campayo at 6 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Depression
What is being tested?: Low Intensity Internet-delivered psychotherapy, Self-guided Internet delivered psychotherapy and Improved treatment as usual
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 6 sitesSpain
Study dates: Sep 2012to Dec 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Spain6 sites

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

Other trials in Spain

About this study

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

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.

Conditions: Depression
Being tested: Low Intensity Internet-delivered psychotherapy, Self-guided Internet delivered psychotherapy, Improved treatment as usual
Keywords: Depression, Computer-delivered psychotherapy, Randomized-controlled trial
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low Intensity Internet-delivered psychotherapyOther
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 psychotherapyOther
No contact with the therapists over the treatment period will be done.
Improved treatment as usualOther
Any kind of treatment administered by the GP to the patient with depression

Study groups in NCT01611818
Study group	Role	What they receive
Low intensity Internet-delivered psychotherapy	Other	Low intensity Internet-delivered psychotherapy + improved treatment as usual by GP. Receives: Other: Low Intensity Internet-delivered psychotherapy
Self-guided Internet-delivered psychotherapy	Other	Self-guided Internet-delivered psychotherapy + improved treatment as usual Receives: Other: Self-guided Internet delivered psychotherapy
Improved treatment as usual by GP	Other	Not described Receives: Other: Improved treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after completing the psychotherapy program

Secondary outcomes (19)

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€).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after completing the psychotherapy program

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2012Dec 2016

First posted5 Jun 2012 (estimated)
Study startSep 2012
Primary completionDec 2014
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (40)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01611818
Sponsor's protocol ID: PI10/01083
Status last verified: Aug 2017
First submitted: 23 May 2012
Last updated: 10 Aug 2017
Results posted: No
Data monitoring committee: No

Publications

Fernandez A, Saameno JA, Pinto-Meza A, Luciano JV, Autonell J, Palao D, Salvador-Carulla L, Campayo JG, Haro JM, Serrano A; DASMAP investigators. Burden of chronic physical conditions and mental disorders in primary care. Br J Psychiatry. 2010 Apr;196(4):302-9. doi: 10.1192/bjp.bp.109.074211.
PubMed 20357307
Cuijpers P, van Straten A, van Oppen P, Andersson G. Are psychological and pharmacologic interventions equally effective in the treatment of adult depressive disorders? A meta-analysis of comparative studies. J Clin Psychiatry. 2008 Nov;69(11):1675-85; quiz 1839-41. doi: 10.4088/jcp.v69n1102. Epub 2008 Aug 12.
PubMed 18945396
Andrews G, Issakidis C, Sanderson K, Corry J, Lapsley H. Utilising survey data to inform public policy: comparison of the cost-effectiveness of treatment of ten mental disorders. Br J Psychiatry. 2004 Jun;184:526-33. doi: 10.1192/bjp.184.6.526.
PubMed 15172947
Kaltenthaler E, Parry G, Beverley C, Ferriter M. Computerised cognitive-behavioural therapy for depression: systematic review. Br J Psychiatry. 2008 Sep;193(3):181-4. doi: 10.1192/bjp.bp.106.025981.
PubMed 18757972
Marks I, Cavanagh K. Computer-aided psychological treatments: evolving issues. Annu Rev Clin Psychol. 2009;5:121-41. doi: 10.1146/annurev.clinpsy.032408.153538.
PubMed 19327027
Andersson G, Cuijpers P. Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther. 2009;38(4):196-205. doi: 10.1080/16506070903318960.
PubMed 20183695
Cuijpers P, Marks IM, van Straten A, Cavanagh K, Gega L, Andersson G. Computer-aided psychotherapy for anxiety disorders: a meta-analytic review. Cogn Behav Ther. 2009;38(2):66-82. doi: 10.1080/16506070802694776.
PubMed 20183688
Titov N. Status of computerized cognitive behavioural therapy for adults. Aust N Z J Psychiatry. 2007 Feb;41(2):95-114. doi: 10.1080/00048670601109873.
PubMed 17464688
Bender JL, Radhakrishnan A, Diorio C, Englesakis M, Jadad AR. Can pain be managed through the Internet? A systematic review of randomized controlled trials. Pain. 2011 Aug;152(8):1740-1750. doi: 10.1016/j.pain.2011.02.012. Epub 2011 May 11.
PubMed 21565446
McCrone P, Knapp M, Proudfoot J, Ryden C, Cavanagh K, Shapiro DA, Ilson S, Gray JA, Goldberg D, Mann A, Marks I, Everitt B, Tylee A. Cost-effectiveness of computerised cognitive-behavioural therapy for anxiety and depression in primary care: randomised controlled trial. Br J Psychiatry. 2004 Jul;185:55-62. doi: 10.1192/bjp.185.1.55.
PubMed 15231556
McCrone P, Marks IM, Mataix-Cols D, Kenwright M, McDonough M. Computer-aided self-exposure therapy for phobia/panic disorder: a pilot economic evaluation. Cogn Behav Ther. 2009;38(2):91-9. doi: 10.1080/16506070802561074.
PubMed 19306148
Hollinghurst S, Peters TJ, Kaur S, Wiles N, Lewis G, Kessler D. Cost-effectiveness of therapist-delivered online cognitive-behavioural therapy for depression: randomised controlled trial. Br J Psychiatry. 2010 Oct;197(4):297-304. doi: 10.1192/bjp.bp.109.073080.
PubMed 20884953
Gerhards SA, de Graaf LE, Jacobs LE, Severens JL, Huibers MJ, Arntz A, Riper H, Widdershoven G, Metsemakers JF, Evers SM. Economic evaluation of online computerised cognitive-behavioural therapy without support for depression in primary care: randomised trial. Br J Psychiatry. 2010 Apr;196(4):310-8. doi: 10.1192/bjp.bp.109.065748.
PubMed 20357309
Learmonth D, Rai S. Taking computerized CBT beyond primary care. Br J Clin Psychol. 2008 Mar;47(Pt 1):111-8. doi: 10.1348/014466507X248599.
PubMed 17939879
Purves DG, Bennett M, Wellman N. An open trial in the NHS of Blues Begone: a new home based computerized CBT program. Behav Cogn Psychother. 2009 Oct;37(5):541-51. doi: 10.1017/S1352465809990282. Epub 2009 Aug 25.
PubMed 19703330

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Low Intensity Versus Self-guided Internet-delivered Psychotherapy for Major Depression: a Multicenter, Controlled, Randomised Study
ClinicalTrials.gov ID: NCT01611818
Acronym / sponsor ID: PI10/01083
Conditions: Depression
Keywords: Depression, Computer-delivered psychotherapy, Randomized-controlled trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Javier Garcia CampayoUniversity, hospital or other
Collaborators: Carlos III Health Institute
Study start: Sep 2012
Primary completion: Dec 2014 (actual)
Study completion: Dec 2016 (actual)
First posted: 5 Jun 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

AIM: To assess the efficacy of low intensity vs self-guided psychotherapy for major depression in the Spanish health system.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Low intensity Internet-delivered psychotherapy	Other	Other: Low Intensity Internet-delivered psychotherapyLow intensity Internet-delivered psychotherapy + improved treatment as usual by GP.
Self-guided Internet-delivered psychotherapy	Other	Other: Self-guided Internet delivered psychotherapySelf-guided Internet-delivered psychotherapy + improved treatment as usual
Improved treatment as usual by GP	Other	Other: Improved treatment as usual

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (2 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Low Intensity Internet-delivered psychotherapyPatients will be contacted by a researcher trained in psychotherapy. Patients can ask for questions or advice to psychotherapists during the study	Other	Low intensity Internet-delivered psychotherapy
Self-guided Internet delivered psychotherapyNo contact with the therapists over the treatment period will be done.	Other	Self-guided Internet-delivered psychotherapy
Improved treatment as usualAny kind of treatment administered by the GP to the patient with depression	Other	Improved treatment as usual by GP

Primary outcome

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.

19 secondary outcomes

Socio-demographic variables.
Time frame: At Baseline
Mini-International Neuropsychiatric Interview (MINI).
Time frame: At Baseline
EuroQoL-5D questionnaire (EQ-5D - Spanish version)
Time frame: At Baseline
Client Service Receipt Inventory - adapted (CSRI - Spanish version)
Time frame: At baseline
Overall Depression Severity and Impairment Scale
Time frame: At baseline
Positive and Negative Affect Scale (PANAS)
Time frame: At Baseline
Credibility/expectancy questionnaire
Time frame: At Baseline
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.
EuroQoL-5D questionnaire (EQ-5D - Spanish version)
Time frame: 3 months after completing the psychotherapy program
EuroQoL-5D questionnaire (EQ-5D - Spanish version)
Time frame: 12 months after completing the psychotherapy program
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
Client Service Receipt Inventory - adapted (CSRI - Spanish version)
Time frame: 3 months after completing the psychotherapy program
Client Service Receipt Inventory - adapted (CSRI - Spanish version)
Time frame: 12 months after completing the psychotherapy program
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.
Overall Depression Severity and Impairment Scale
Time frame: 3 months after completing the psychotherapy program
Overall Depression Severity and Impairment Scale
Time frame: 12 months after completing the psychotherapy program
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.
Positive and Negative Affect Scale (PANAS)
Time frame: 3 months after completing the psychotherapy program
Positive and Negative Affect Scale (PANAS)
Time frame: 12 months after completing the psychotherapy program

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
Background: PubMed 20357307Fernandez A, Saameno JA, Pinto-Meza A, Luciano JV, Autonell J, Palao D, Salvador-Carulla L, Campayo JG, Haro JM, Serrano A; DASMAP investigators. Burden of chronic physical conditions and mental disorders in primary care. Br J Psychiatry. 2010 Apr;196(4):302-9. doi: 10.1192/bjp.bp.109.074211.
Background: PubMed 18945396Cuijpers P, van Straten A, van Oppen P, Andersson G. Are psychological and pharmacologic interventions equally effective in the treatment of adult depressive disorders? A meta-analysis of comparative studies. J Clin Psychiatry. 2008 Nov;69(11):1675-85; quiz 1839-41. doi: 10.4088/jcp.v69n1102. Epub 2008 Aug 12.
Background: PubMed 15172947Andrews G, Issakidis C, Sanderson K, Corry J, Lapsley H. Utilising survey data to inform public policy: comparison of the cost-effectiveness of treatment of ten mental disorders. Br J Psychiatry. 2004 Jun;184:526-33. doi: 10.1192/bjp.184.6.526.
Background: PubMed 18757972Kaltenthaler E, Parry G, Beverley C, Ferriter M. Computerised cognitive-behavioural therapy for depression: systematic review. Br J Psychiatry. 2008 Sep;193(3):181-4. doi: 10.1192/bjp.bp.106.025981.
Background: PubMed 19327027Marks I, Cavanagh K. Computer-aided psychological treatments: evolving issues. Annu Rev Clin Psychol. 2009;5:121-41. doi: 10.1146/annurev.clinpsy.032408.153538.
Background: PubMed 20183695Andersson G, Cuijpers P. Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther. 2009;38(4):196-205. doi: 10.1080/16506070903318960.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Javier García Campayo, PhD principal investigator

Miguel Servet Hospital & University of Zaragoza, Spain

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severity of depressive symptomatology measured by Beck Depression Inventory II (time frame: At baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01611818, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.