Major Depressive DisorderPROMETEOIINCT02369393
Efficacy of Two Internet Delivered Intervention Programs for Depression: Behavioral Activation vs Physical Activity
A study testing Behavioral Activation and Physical Activity in people with Major Depressive Disorder, run by Universitat Jaume I at 1 site in Spain.
Trial summary
To compare the clinical and cost-effectiveness of Behavioral Activation (BA) and Physical Activity (PA) for adults with major depressive disorder (MDD) or adjustment disorder with depressive symptomatology with a wait list control group (WL) in Spanish population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Behavioral Activation and Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 2 Nov 2021to 1 Feb 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years of age or older
- Meet DSM-IV diagnostic criteria for MDD and adjustment disorder confirmed by MINI International Neuropsychiatric Interview version 5.0 and SCID I
- A score of 5 or higher on the PHQ-9 screening questionnaire.
Who cannot join
- Current high risk for suicide according to the MINI Interview section C
- Serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview
- Currently receiving psychological treatment for depression in primary or specialised mental health care
- Being unable to comprehend the spoken and written language (Spanish)
- Not having access to a PC and fast Internet connection (i.e. broadband or comparable).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Depression: Efficacy and Efficiency of Two Self-administered Online Intervention Protocols Based on Behavioral Activation and Physical Activity
To compare the clinical and cost-effectiveness of Behavioral Activation (BA) and Physical Activity (PA) for adults with major depressive disorder (MDD) or adjustment disorder with depressive symptomatology with a wait list control group (WL) in Spanish population.
Read the detailed description
Research shows that in 2030 (Mathers and Loncar, 2006) depression will become one of the three leading causes of disability. Depression is a common mental disorder with a negative impact on mental well-being, quality of life, and social and work-related functioning both in the short and longer term.
Additionally, depression is associated with increased morbidity, mortality, health care utilization and health care costs. On a population level, depression is one of the most costly diseases. The economic costs of depression were estimated at €136.3 billion (EU25) in 2010 in the EU and are still rising. European health care systems face the challenge of improving access to cost-effective treatments while simultaneously working to sustain budgetary stability in times of economic austerity.
Internet-based depression treatment appears a very promising alternative to current routine depression treatment strategies. Meta-analyses have demonstrated the clinical effectiveness and potential cost-effectiveness of Internet-based treatment for depression in controlled research setting. Internet-based treatment thus has the potential to keep depression treatment affordable, as it enables mental health care providers to reach out to large populations needing depression treatment at a better cost-effectiveness, but with similar levels of clinical efficacy and quality of care.
In Spain the trial will be carried out in a community sample, comparing the clinical and cost-effectiveness of BA or PA with WL for adults with major depressive disorder (MDD) and adjustment disorder with depressive symptomatology. Respondents will be followed until 6 months after baseline (measures will be taken at BL, 3 months, and 6 months).
- Conditions
- Major Depressive Disorder
- Being tested
- Behavioral Activation, Physical Activity
- Keywords
- Internet based treatment, Depression, Efficacy, Cost-effectiveness, Behavioral Activation, Self-applied, Ecological Momentary Assessment, Physical Activity
- Medical subject headings
- Depressive Disorder, Major, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
Behavioral Activation intervention promotes the involvement in meaningful activities close to personal values.
Physical ActivityBehavioural
Physical Activity intervention promotes the gradual increase of the frequency and intensity of PA levels, with special attention to motivational strategies.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation | Experimental | BA treatment for depression is a simple, cost-effective method. There is evidence that the behavioral component may be the active mechanism of change in cognitive-behavioral treatments of clinical depression. One of the main objectives of the treatment is to systematically increase exposure to positive activities, and thereby improve affect and corresponding cognitions. Treatment will be delivered through an Internet based treatment platform with mobile phone components (either integrated in the treatment platform or as a separate system). The core components are: 1) psycho-education, 2) identifying important values and significant activities, 3) activity structuring and scheduling, 4) relapse prevention. These will be delivered over 4 modules. There will be a minimal therapist support. Receives: Behavioral: Behavioral Activation |
| Waiting list control group | No intervention | In the waiting list control group (WL), subjects will receive no treatment during 8 weeks. We will not interfere but we will monitor carefully through self-report. Then participants will be randomised to the two treatment groups. |
| Physical Activity | Experimental | There is evidence to suggest that the addition of cognitive behavioral therapies, specifically exercise, can improve treatment outcomes for many patients. Exercise is a behavioral intervention that has shown great promise in alleviating symptoms of depression. The treatment will be delivered through an Internet based treatment platform with mobile phone components (either integrated in the treatment platform or as a separate system). The core components of the PA treatment are: 1) psychoeducation: understand the mental health benefits of physical activity, 2) learn about the types and amounts of physical activity recommended, 3) motivation to perform and maintain physical activities, 4) relapse prevention. These will be delivered over 4 modules. There will be a minimal therapist support. Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire-9
Measured: Change from baseline to 2 months, 5 months, and 8 months
Change in the Beck Depression Inventory
Measured: Change from baseline to 2 months, 5 months, and 8 months
Secondary outcomes (10)
Change in the EQ-5D-5L (EuroQol)
Measured: Change from baseline to 2 months, 5 months, and 8 months
Change in the Quality of Life (QLI)
Measured: Change from baseline to 2 months, 5 months, and 8 months
Change in the Overall Anxiety Severity and Impairment Scale (OASIS)
Measured: Change from baseline to 2 months, 5 months, and 8 months
Change in the Positive and Negative Affect Scale (PANAS)
Measured: Change from baseline to 2 months, 5 months, and 8 months
Change in the Happiness Scale (Fordyce)
Measured: Change from baseline to 2 months, 5 months, and 8 months
Change in the Satisfaction with Life Scale (SWLS, Diener)
Measured: Change from baseline to 2 months, 5 months, and 8 months
Change in the Ryff Scale of Psychological Wellbeing
Measured: Change from baseline to 2 months, 5 months, and 8 months
Change in the Behavioral Activation for Depression Scale - Short Form (BADS-SF)
Measured: Change from baseline to 2 months, 5 months, and 8 months
Change in the Environmental Reward Observation Scale (EROS)
Measured: Change from baseline to 2 months, 5 months, and 8 months
Change in Beck Depression Inventory (BDI-II)
Measured: Change from baseline to 2 months, 5 months, and 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study start2 Nov 2021
- Primary completion30 Apr 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valencia, Universitat Politècnica de València
- Responsible party
- Sponsor
- Investigators
- Cristina Botella, PhD, Principal investigator, Universitat Jaume I;CIBERObn ISC III, SpainRosa Baños, PhD, Principal investigator, Universitat de Valencia; CIBERObn ISC III, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369393
- Sponsor's protocol ID
- UJaimeI06
- Acronym
- PROMETEOII
- Status last verified
- Jul 2023
- First submitted
- 16 Feb 2015
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 20183695Cavanagh K, Shapiro DA. Computer treatment for common mental health problems. J Clin Psychol. 2004 Mar;60(3):239-51. doi: 10.1002/jclp.10261.
PubMed 14981789Coffman SJ, Martell CR, Dimidjian S, Gallop R, Hollon SD. Extreme nonresponse in cognitive therapy: can behavioral activation succeed where cognitive therapy fails? J Consult Clin Psychol. 2007 Aug;75(4):531-41. doi: 10.1037/0022-006X.75.4.531.
PubMed 17663608Davidson TM, Yuen EK, Felton JW, McCauley J, Gros KS, Ruggiero KJ. Feasibility assessment of a brief, web-based behavioral activation intervention for adolescents with depressed mood. Int J Psychiatry Med. 2014;48(1):69-82. doi: 10.2190/PM.48.1.f.
PubMed 25354927Sudak DM, Majeed MH, Youngman B. Behavioral activation: a strategy to enhance treatment response. J Psychiatr Pract. 2014 Jul;20(4):269-75. doi: 10.1097/01.pra.0000452563.05911.c9.
PubMed 25036582Cuijpers P, Donker T, van Straten A, Li J, Andersson G. Is guided self-help as effective as face-to-face psychotherapy for depression and anxiety disorders? A systematic review and meta-analysis of comparative outcome studies. Psychol Med. 2010 Dec;40(12):1943-57. doi: 10.1017/S0033291710000772. Epub 2010 Apr 21.
PubMed 20406528Soucy Chartier I, Provencher MD. Behavioural activation for depression: efficacy, effectiveness and dissemination. J Affect Disord. 2013 Mar 5;145(3):292-9. doi: 10.1016/j.jad.2012.07.023. Epub 2012 Aug 9.
PubMed 22884236Churchill R, Moore TH, Furukawa TA, Caldwell DM, Davies P, Jones H, Shinohara K, Imai H, Lewis G, Hunot V. 'Third wave' cognitive and behavioural therapies versus treatment as usual for depression. Cochrane Database Syst Rev. 2013 Oct 18;2013(10):CD008705. doi: 10.1002/14651858.CD008705.pub2.
PubMed 24142810Dimidjian S, Barrera M Jr, Martell C, Munoz RF, Lewinsohn PM. The origins and current status of behavioral activation treatments for depression. Annu Rev Clin Psychol. 2011;7:1-38. doi: 10.1146/annurev-clinpsy-032210-104535.
PubMed 21275642Dimidjian S, Hollon SD, Dobson KS, Schmaling KB, Kohlenberg RJ, Addis ME, Gallop R, McGlinchey JB, Markley DK, Gollan JK, Atkins DC, Dunner DL, Jacobson NS. Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression. J Consult Clin Psychol. 2006 Aug;74(4):658-70. doi: 10.1037/0022-006X.74.4.658.
PubMed 16881773Fitzsimons CF, Baker G, Gray SR, Nimmo MA, Mutrie N; Scottish Physical Activity Research Collaboration (SPARColl). Does physical activity counselling enhance the effects of a pedometer-based intervention over the long-term: 12-month findings from the Walking for Wellbeing in the west study. BMC Public Health. 2012 Mar 19;12:206. doi: 10.1186/1471-2458-12-206.
PubMed 22429600Azevedo Da Silva M, Singh-Manoux A, Brunner EJ, Kaffashian S, Shipley MJ, Kivimaki M, Nabi H. Bidirectional association between physical activity and symptoms of anxiety and depression: the Whitehall II study. Eur J Epidemiol. 2012 Jul;27(7):537-46. doi: 10.1007/s10654-012-9692-8. Epub 2012 May 24.
PubMed 22623145Loprinzi PD, Mahoney S. Concurrent occurrence of multiple positive lifestyle behaviors and depression among adults in the United States. J Affect Disord. 2014 Aug;165:126-30. doi: 10.1016/j.jad.2014.04.073. Epub 2014 May 5.
PubMed 24882189Goodwin RD. Association between physical activity and mental disorders among adults in the United States. Prev Med. 2003 Jun;36(6):698-703. doi: 10.1016/s0091-7435(03)00042-2.
PubMed 12744913Harvey SB, Hotopf M, Overland S, Mykletun A. Physical activity and common mental disorders. Br J Psychiatry. 2010 Nov;197(5):357-64. doi: 10.1192/bjp.bp.109.075176.
PubMed 21037212
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Depression: Efficacy and Efficiency of Two Self-administered Online Intervention Protocols Based on Behavioral Activation and Physical Activity
- ClinicalTrials.gov ID
- NCT02369393
- Acronym / sponsor ID
- PROMETEOII / UJaimeI06
- Conditions
- Major Depressive Disorder
- Keywords
- Internet based treatment, Depression, Efficacy, Cost-effectiveness, Behavioral Activation, Self-applied, Ecological Momentary Assessment, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Collaborators
- University of Valencia, Universitat Politècnica de València
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 23 Feb 2015 (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.
To compare the clinical and cost-effectiveness of Behavioral Activation (BA) and Physical Activity (PA) for adults with major depressive disorder (MDD) or adjustment disorder with depressive symptomatology with a wait list control group (WL) in Spanish population.
Detailed description
Research shows that in 2030 (Mathers and Loncar, 2006) depression will become one of the three leading causes of disability. Depression is a common mental disorder with a negative impact on mental well-being, quality of life, and social and work-related functioning both in the short and longer term.
Additionally, depression is associated with increased morbidity, mortality, health care utilization and health care costs. On a population level, depression is one of the most costly diseases. The economic costs of depression were estimated at €136.3 billion (EU25) in 2010 in the EU and are still rising. European health care systems face the challenge of improving access to cost-effective treatments while simultaneously working to sustain budgetary stability in times of economic austerity.
Internet-based depression treatment appears a very promising alternative to current routine depression treatment strategies. Meta-analyses have demonstrated the clinical effectiveness and potential cost-effectiveness of Internet-based treatment for depression in controlled research setting. Internet-based treatment thus has the potential to keep depression treatment affordable, as it enables mental health care providers to reach out to large populations needing depression treatment at a better cost-effectiveness, but with similar levels of clinical efficacy and quality of care.
In Spain the trial will be carried out in a community sample, comparing the clinical and cost-effectiveness of BA or PA with WL for adults with major depressive disorder (MDD) and adjustment disorder with depressive symptomatology. Respondents will be followed until 6 months after baseline (measures will be taken at BL, 3 months, and 6 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation | Experimental | Behavioral: Behavioral ActivationBA treatment for depression is a simple, cost-effective method. There is evidence that the behavioral component may be the active mechanism of change in cognitive-behavioral treatments of clinical depression. One of the main objectives of the treatment is to systematically increase exposure to positive activities, and thereby improve affect and corresponding cognitions. Treatment will be delivered through an Internet based treatment platform with mobile phone components (either integrated in the treatment platform or as a separate system). The core components are: 1) psycho-education, 2) identifying important values and significant activities, 3) activity structuring and scheduling, 4) relapse prevention. These will be delivered over 4 modules. There will be a minimal therapist support. |
| Waiting list control group | No intervention | –In the waiting list control group (WL), subjects will receive no treatment during 8 weeks. We will not interfere but we will monitor carefully through self-report. Then participants will be randomised to the two treatment groups. |
| Physical Activity | Experimental | Behavioral: Physical ActivityThere is evidence to suggest that the addition of cognitive behavioral therapies, specifically exercise, can improve treatment outcomes for many patients. Exercise is a behavioral intervention that has shown great promise in alleviating symptoms of depression. The treatment will be delivered through an Internet based treatment platform with mobile phone components (either integrated in the treatment platform or as a separate system). The core components of the PA treatment are: 1) psychoeducation: understand the mental health benefits of physical activity, 2) learn about the types and amounts of physical activity recommended, 3) motivation to perform and maintain physical activities, 4) relapse prevention. These will be delivered over 4 modules. There will be a minimal therapist support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being 18 years of age or older
- Meet DSM-IV diagnostic criteria for MDD and adjustment disorder confirmed by MINI International Neuropsychiatric Interview version 5.0 and SCID I
- A score of 5 or higher on the PHQ-9 screening questionnaire.
Key exclusion criteria (5 listed)
- Current high risk for suicide according to the MINI Interview section C
- Serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview
- Currently receiving psychological treatment for depression in primary or specialised mental health care
- Being unable to comprehend the spoken and written language (Spanish)
- Not having access to a PC and fast Internet connection (i.e. broadband or comparable).
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 |
|---|---|---|
| Behavioral ActivationBehavioral Activation intervention promotes the involvement in meaningful activities close to personal values. | Behavioural | Behavioral Activation |
| Physical ActivityPhysical Activity intervention promotes the gradual increase of the frequency and intensity of PA levels, with special attention to motivational strategies. | Behavioural | Physical Activity |
Primary outcome
Change in Patient Health Questionnaire-9
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in the Beck Depression Inventory
Time frame: Change from baseline to 2 months, 5 months, and 8 months
10 secondary outcomes
Change in the EQ-5D-5L (EuroQol)
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in the Quality of Life (QLI)
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in the Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in the Positive and Negative Affect Scale (PANAS)
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in the Happiness Scale (Fordyce)
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in the Satisfaction with Life Scale (SWLS, Diener)
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in the Ryff Scale of Psychological Wellbeing
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in the Behavioral Activation for Depression Scale - Short Form (BADS-SF)
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in the Environmental Reward Observation Scale (EROS)
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in Beck Depression Inventory (BDI-II)
Time frame: Change from baseline to 2 months, 5 months, and 8 months
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 11 Jul 2023.
- 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.
- Background: PubMed 14981789Cavanagh K, Shapiro DA. Computer treatment for common mental health problems. J Clin Psychol. 2004 Mar;60(3):239-51. doi: 10.1002/jclp.10261.
- Background: PubMed 17663608Coffman SJ, Martell CR, Dimidjian S, Gallop R, Hollon SD. Extreme nonresponse in cognitive therapy: can behavioral activation succeed where cognitive therapy fails? J Consult Clin Psychol. 2007 Aug;75(4):531-41. doi: 10.1037/0022-006X.75.4.531.
- Background: PubMed 25354927Davidson TM, Yuen EK, Felton JW, McCauley J, Gros KS, Ruggiero KJ. Feasibility assessment of a brief, web-based behavioral activation intervention for adolescents with depressed mood. Int J Psychiatry Med. 2014;48(1):69-82. doi: 10.2190/PM.48.1.f.
- Background: PubMed 25036582Sudak DM, Majeed MH, Youngman B. Behavioral activation: a strategy to enhance treatment response. J Psychiatr Pract. 2014 Jul;20(4):269-75. doi: 10.1097/01.pra.0000452563.05911.c9.
- Background: PubMed 20406528Cuijpers P, Donker T, van Straten A, Li J, Andersson G. Is guided self-help as effective as face-to-face psychotherapy for depression and anxiety disorders? A systematic review and meta-analysis of comparative outcome studies. Psychol Med. 2010 Dec;40(12):1943-57. doi: 10.1017/S0033291710000772. Epub 2010 Apr 21.
- Background: PubMed 22884236Soucy Chartier I, Provencher MD. Behavioural activation for depression: efficacy, effectiveness and dissemination. J Affect Disord. 2013 Mar 5;145(3):292-9. doi: 10.1016/j.jad.2012.07.023. Epub 2012 Aug 9.
- Background: PubMed 24142810Churchill R, Moore TH, Furukawa TA, Caldwell DM, Davies P, Jones H, Shinohara K, Imai H, Lewis G, Hunot V. 'Third wave' cognitive and behavioural therapies versus treatment as usual for depression. Cochrane Database Syst Rev. 2013 Oct 18;2013(10):CD008705. doi: 10.1002/14651858.CD008705.pub2.
- Background: PubMed 21275642Dimidjian S, Barrera M Jr, Martell C, Munoz RF, Lewinsohn PM. The origins and current status of behavioral activation treatments for depression. Annu Rev Clin Psychol. 2011;7:1-38. doi: 10.1146/annurev-clinpsy-032210-104535.
- Background: PubMed 16881773Dimidjian S, Hollon SD, Dobson KS, Schmaling KB, Kohlenberg RJ, Addis ME, Gallop R, McGlinchey JB, Markley DK, Gollan JK, Atkins DC, Dunner DL, Jacobson NS. Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression. J Consult Clin Psychol. 2006 Aug;74(4):658-70. doi: 10.1037/0022-006X.74.4.658.
- Background: PubMed 22429600Fitzsimons CF, Baker G, Gray SR, Nimmo MA, Mutrie N; Scottish Physical Activity Research Collaboration (SPARColl). Does physical activity counselling enhance the effects of a pedometer-based intervention over the long-term: 12-month findings from the Walking for Wellbeing in the west study. BMC Public Health. 2012 Mar 19;12:206. doi: 10.1186/1471-2458-12-206.
- Background: PubMed 22623145Azevedo Da Silva M, Singh-Manoux A, Brunner EJ, Kaffashian S, Shipley MJ, Kivimaki M, Nabi H. Bidirectional association between physical activity and symptoms of anxiety and depression: the Whitehall II study. Eur J Epidemiol. 2012 Jul;27(7):537-46. doi: 10.1007/s10654-012-9692-8. Epub 2012 May 24.
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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.
Cristina Botella, PhD principal investigator
Universitat Jaume I;CIBERObn ISC III, Spain
Rosa Baños, PhD principal investigator
Universitat de Valencia; CIBERObn ISC III, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation and Physical Activity in people with Major Depressive Disorder, run by Universitat Jaume I at 1 site in Spain.
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 3 inclusion and 5 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 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in Patient Health Questionnaire-9 (time frame: Change from baseline to 2 months, 5 months, and 8 months). The study lists 2 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 NCT02369393, which also lists 30 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 11 Jul 2023.