Depressive SymptomsNCT04830527
EMA Baseline Screening System for Therapists Who Treat Youths With Depressive Symptoms
A study testing EMA prompting for patients and PDF Reports for therapists in people with Depressive Symptoms, run by Vania Martínez-Nahuel at 1 site in Chile.
Trial summary
Youth depression is a matter of concern worldwide. It affects an important part of the young population around the world and its consequences both physically and mentally make this issue an important research field for psychologists and other health related professionals (Zuckerbrot, Cheung, Jensen, Stein \& Laraque… Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- EMA prompting for patients and PDF Reports for therapists
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChile
- Study dates
- 24 Nov 2020to 30 Nov 2021
- 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 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Owning a mobile phone with permanent access to the internet,
- Scoring from eleven to nineteen points in the PHQ-9 questionnaire.
- Having completed the eighth grade of basic education.
- Having 1 or more years of clinical experience.
Who cannot join
- Being diagnosed with Depression with psychotic symptoms,
- Having a depressive episode as part of a bipolar disorder diagnosis
- Having suicidal thoughts and/or behaviour as measured by the PHQ-9 and evaluated by the physician.
- Alcohol and/or substance abuse.
- Having less than 1 year of clinical experience.
- Having participated in the design of PDF reports.
Trial locations and contacts
1 site in 1 country.
Chile1 site
CEMERA, Faculty of Medicine, Universidad de Chile
Santiago, Santiago Metropolitan, 8380455
About this study
Official title: Development and Evaluation of an Ecological Momentary Assessment (EMA) Baseline Screening System for Therapists Who Treat Youths With Depressive Symptoms
Youth depression is a matter of concern worldwide. It affects an important part of the young population around the world and its consequences both physically and mentally make this issue an important research field for psychologists and other health related professionals (Zuckerbrot, Cheung, Jensen, Stein \& Laraque, 2018). Two of the biggest challenges that clinicians and researchers face when dealing with youth depression are adherence and the establishment of a therapeutic alliance (TA; Nock \& Ferriter, 2005). While several treatments are available to relief depressive symptomatology in youths, a significant number do not access them for a variety of reasons (DiMatteo, Lepper \& Corgan, 2000). In the last decades, substantial research has been conducted on how youths and the general population perceive therapy, and different methods have been developed to assess clients and therapists in order to improve outcomes and other aspects of the psychotherapy process, such as feedback tools and real-time measurements like Ecological Momentary Assessment (EMA) (Shiffman, et al., 2008). With the aid of Information Communication Technologies (ICTs) and eMental Health strategies, feedback and assessment tools can be presented in a friendly manner, providing a novel way to possibly improving adherence rates and TA scores. This study aims to develop and test the effectiveness of an Ecological Momentary Assessment mobile application to improve initial adherence and TA in psychotherapy for youths with depression.
The hypotheses for this trial are:
- Applying an EMA baseline screening application one week before the beginning of treatment for youth depression will significantly improve the TA.
- Applying an EMA baseline screening application one week before the beginning of treatment for youth depression will significantly improve initial adherence.
- Conditions
- Depressive Symptoms
- Being tested
- EMA prompting for patients, PDF Reports for therapists
- Keywords
- depression, therapeutic alliance, youth, Ecological Momentary Assessment, e-mental Health, e-Health, adherence
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMA prompting for patientsBehavioural
EMA prompting will consist of the delivery of the PHQ-4 and PANAS questionnaires, as well as basic identification, therapy motivations and expectations, location, current activity and social interactions.
These prompts will be presented to patients during a 7 day period, 5 times per day.
PDF Reports for therapistsBehavioural
After the patients' EMA data is collected, a previously designed R script will summarize and transform the data into a brief and graphic report for therapists in the experimental arm of the study. These reports are intended to provide detailed information about the patients' mood, anxiety levels, positive and negative affects, as well as crossed data such as mood according to location, anxiety according to activity, etc.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients in experimental group will receive EMA prompts. Therapists in this group will receive a summarized PDF report before the beginning of the first psychotherapy session. The report will include graphic summarized data from the EMA prompts. Receives: Behavioral: EMA prompting for patients; Behavioral: PDF Reports for therapists |
| Control group | Active comparator | Patients in control group will receive the EMA prompts in the same manner as patients in the experimental group.
Therapists in this group will not receive the PDF reports, and instead will get raw scores from a screening evaluation conducted with patients in the recruitment phase of the study. Receives: Behavioral: EMA prompting for patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working Alliance Inventory, Patient Form (WAI-P)
Likert scale with answers that range from 1 to 7. Higher scores suggest a better perception of the Therapeutic Alliance.
Measured: Immediately after the end of first three psychotherapy sessions.
Secondary outcomes (2)
Working Alliance Inventory, Therapist Form (WAI-T)
Likert scale with answers that range from 1 to 7. Higher scores suggest a better perception of the Therapeutic Alliance.
Measured: Immediately after the end of first three psychotherapy sessions.
Assistance to sessions
Assistance to sessions will be registered by therapists as a measurement of initial adherence.
Measured: Immediately after the end of first three psychotherapy sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start24 Nov 2020
- Primary completion24 Nov 2021
- Study completion30 Nov 2021
Why it stopped: The study was terminated early due to the difficulty in recruiting cases during a pandemic period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vania Martínez-Nahuel
- Sponsor type
- University, hospital or other
- Collaborators
- ANID - Millennium Science Initiative Program - NCS17_03 Millennium Nucleus to Improve the Mental Health of Adolescents and Youths (Imhay), Santiago, Chile, Millennium Institute on Immunology and Immunotherapy, Center for Psychotherapy Research, University Hospital Heidelberg, Heidelberg, Germany
- Responsible party
- Sponsor-investigator, Vania Martínez-Nahuel, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830527
- Sponsor's protocol ID
- 030-2020
- Status last verified
- May 2022
- First submitted
- 30 Mar 2021
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abras, C., Maloney-Krichmar, D., Preece, J. (2004) User-Centered Design. In Bainbridge, W. Encyclopedia of Human-Computer Interaction. Thousand Oaks: Sage Publications.
Borghero F, Martinez V, Zitko P, Vohringer PA, Cavada G, Rojas G. [Screening depressive episodes in adolescents. Validation of the Patient Health Questionnaire-9 (PHQ-9)]. Rev Med Chil. 2018 Apr;146(4):479-486. doi: 10.4067/s0034-98872018000400479. Spanish.
PubMed 29999123Cipriani A, Zhou X, Del Giovane C, Hetrick SE, Qin B, Whittington C, Coghill D, Zhang Y, Hazell P, Leucht S, Cuijpers P, Pu J, Cohen D, Ravindran AV, Liu Y, Michael KD, Yang L, Liu L, Xie P. Comparative efficacy and tolerability of antidepressants for major depressive disorder in children and adolescents: a network meta-analysis. Lancet. 2016 Aug 27;388(10047):881-90. doi: 10.1016/S0140-6736(16)30385-3. Epub 2016 Jun 8.
PubMed 27289172Clark MS, Jansen KL, Cloy JA. Treatment of childhood and adolescent depression. Am Fam Physician. 2012 Sep 1;86(5):442-8.
PubMed 22963063Cox GR, Callahan P, Churchill R, Hunot V, Merry SN, Parker AG, Hetrick SE. Psychological therapies versus antidepressant medication, alone and in combination for depression in children and adolescents. Cochrane Database Syst Rev. 2014 Nov 30;2014(11):CD008324. doi: 10.1002/14651858.CD008324.pub3.
PubMed 25433518David-Ferdon C, Kaslow NJ. Evidence-based psychosocial treatments for child and adolescent depression. J Clin Child Adolesc Psychol. 2008 Jan;37(1):62-104. doi: 10.1080/15374410701817865.
PubMed 18444054Eapen V, Crncec R. Strategies and challenges in the management of adolescent depression. Curr Opin Psychiatry. 2012 Jan;25(1):7-13. doi: 10.1097/YCO.0b013e32834de3bd.
PubMed 22156932Fernández, O., Pérez, C., Gloger, S., Krause, M., (2015) Importancia de los cambios iniciales en psicoterapia con jovenes, Terapia Psicológica, (33)3, pp. 247 - 255.
Fernández, O. M., Herrera-Salinas, P. & Escobar-Martínez, M. J. (2016). youthes en Psicoterapia: Su Representación de la Relación Terapéutica. Revista Latinoamericana de Ciencias Sociales, Niñez y Juventud, 14 (1), pp. 559-575.
Fernandez, O.M., Krause, M., & Pérez, J.C. (2016). Therapeutic alliance in the initial phase of psychotherapy with ado- lescents: different perspectives and their association with therapeutic outcomes. Research in Psychotherapy: Psychopathology, Process and Outcome, 19(1), 1-9. doi: 10.4081/ripppo.2016.180
Goodyer IM, Reynolds S, Barrett B, Byford S, Dubicka B, Hill J, Holland F, Kelvin R, Midgley N, Roberts C, Senior R, Target M, Widmer B, Wilkinson P, Fonagy P. Cognitive-behavioural therapy and short-term psychoanalytic psychotherapy versus brief psychosocial intervention in adolescents with unipolar major depression (IMPACT): a multicentre, pragmatic, observer-blind, randomised controlled trial. Health Technol Assess. 2017 Mar;21(12):1-94. doi: 10.3310/hta21120.
PubMed 28394249Hatcher, R., & Gillaspy, J., (2006) Development and validation of a revised short version of the working alliance inventory, Psychotherapy Research, 16:1, 12-25, DOI: 10.1080/10503300500352500
Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.
PubMed 14583691Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.
PubMed 17339617Kelders SM, Kok RN, Ossebaard HC, Van Gemert-Pijnen JE. Persuasive system design does matter: a systematic review of adherence to web-based interventions. J Med Internet Res. 2012 Nov 14;14(6):e152. doi: 10.2196/jmir.2104.
PubMed 23151820
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an Ecological Momentary Assessment (EMA) Baseline Screening System for Therapists Who Treat Youths With Depressive Symptoms
- ClinicalTrials.gov ID
- NCT04830527
- Acronym / sponsor ID
- 030-2020
- Conditions
- Depressive Symptoms
- Keywords
- depression, therapeutic alliance, youth, Ecological Momentary Assessment, e-mental Health, e-Health, adherence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to the difficulty in recruiting cases during a pandemic period.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vania Martínez-NahuelUniversity, hospital or other
- Collaborators
- ANID - Millennium Science Initiative Program - NCS17_03 Millennium Nucleus to Improve the Mental Health of Adolescents and Youths (Imhay), Santiago, Chile, Millennium Institute on Immunology and Immunotherapy, Center for Psychotherapy Research, University Hospital Heidelberg, Heidelberg, Germany
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 5 Apr 2021 (actual)
- 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.
Youth depression is a matter of concern worldwide. It affects an important part of the young population around the world and its consequences both physically and mentally make this issue an important research field for psychologists and other health related professionals (Zuckerbrot, Cheung, Jensen, Stein \& Laraque, 2018). Two of the biggest challenges that clinicians and researchers face when dealing with youth depression are adherence and the establishment of a therapeutic alliance (TA; Nock \& Ferriter, 2005). While several treatments are available to relief depressive symptomatology in youths, a significant number do not access them for a variety of reasons (DiMatteo, Lepper \& Corgan, 2000). In the last decades, substantial research has been conducted on how youths and the general population perceive therapy, and different methods have been developed to assess clients and therapists in order to improve outcomes and other aspects of the psychotherapy process, such as feedback tools and real-time measurements like Ecological Momentary Assessment (EMA) (Shiffman, et al., 2008). With the aid of Information Communication Technologies (ICTs) and eMental Health strategies, feedback and assessment tools can be presented in a friendly manner, providing a novel way to possibly improving adherence rates and TA scores. This study aims to develop and test the effectiveness of an Ecological Momentary Assessment mobile application to improve initial adherence and TA in psychotherapy for youths with depression.
The hypotheses for this trial are:
- Applying an EMA baseline screening application one week before the beginning of treatment for youth depression will significantly improve the TA.
- Applying an EMA baseline screening application one week before the beginning of treatment for youth depression will significantly improve initial adherence.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: EMA prompting for patients, Behavioral: PDF Reports for therapistsPatients in experimental group will receive EMA prompts. Therapists in this group will receive a summarized PDF report before the beginning of the first psychotherapy session. The report will include graphic summarized data from the EMA prompts. |
| Control group | Active comparator | Behavioral: EMA prompting for patientsPatients in control group will receive the EMA prompts in the same manner as patients in the experimental group. Therapists in this group will not receive the PDF reports, and instead will get raw scores from a screening evaluation conducted with patients in the recruitment phase of the study. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Owning a mobile phone with permanent access to the internet,
- Scoring from eleven to nineteen points in the PHQ-9 questionnaire.
- Having completed the eighth grade of basic education.
- Having 1 or more years of clinical experience.
Key exclusion criteria (6 listed)
- Being diagnosed with Depression with psychotic symptoms,
- Having a depressive episode as part of a bipolar disorder diagnosis
- Having suicidal thoughts and/or behaviour as measured by the PHQ-9 and evaluated by the physician.
- Alcohol and/or substance abuse.
- Having less than 1 year of clinical experience.
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 |
|---|---|---|
| EMA prompting for patientsEMA prompting will consist of the delivery of the PHQ-4 and PANAS questionnaires, as well as basic identification, therapy motivations and expectations, location, current activity and social interactions. These prompts will be presented to patients during a 7 day period, 5 times per day. | Behavioural | Control group, Intervention group |
| PDF Reports for therapistsAfter the patients' EMA data is collected, a previously designed R script will summarize and transform the data into a brief and graphic report for therapists in the experimental arm of the study. These reports are intended to provide detailed information about the patients' mood, anxiety levels, positive and negative affects, as well as crossed data such as mood according to location, anxiety according to activity, etc. | Behavioural | Intervention group |
Primary outcome
Working Alliance Inventory, Patient Form (WAI-P)
Time frame: Immediately after the end of first three psychotherapy sessions.
Likert scale with answers that range from 1 to 7. Higher scores suggest a better perception of the Therapeutic Alliance.
2 secondary outcomes
Working Alliance Inventory, Therapist Form (WAI-T)
Time frame: Immediately after the end of first three psychotherapy sessions.
Assistance to sessions
Time frame: Immediately after the end of first three psychotherapy sessions.
Results and safety
The study was stopped early (reason given: The study was terminated early due to the difficulty in recruiting cases during a pandemic period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- BackgroundAbras, C., Maloney-Krichmar, D., Preece, J. (2004) User-Centered Design. In Bainbridge, W. Encyclopedia of Human-Computer Interaction. Thousand Oaks: Sage Publications.
- Background: PubMed 29999123Borghero F, Martinez V, Zitko P, Vohringer PA, Cavada G, Rojas G. [Screening depressive episodes in adolescents. Validation of the Patient Health Questionnaire-9 (PHQ-9)]. Rev Med Chil. 2018 Apr;146(4):479-486. doi: 10.4067/s0034-98872018000400479. Spanish.
- Background: PubMed 27289172Cipriani A, Zhou X, Del Giovane C, Hetrick SE, Qin B, Whittington C, Coghill D, Zhang Y, Hazell P, Leucht S, Cuijpers P, Pu J, Cohen D, Ravindran AV, Liu Y, Michael KD, Yang L, Liu L, Xie P. Comparative efficacy and tolerability of antidepressants for major depressive disorder in children and adolescents: a network meta-analysis. Lancet. 2016 Aug 27;388(10047):881-90. doi: 10.1016/S0140-6736(16)30385-3. Epub 2016 Jun 8.
- Background: PubMed 22963063Clark MS, Jansen KL, Cloy JA. Treatment of childhood and adolescent depression. Am Fam Physician. 2012 Sep 1;86(5):442-8.
- Background: PubMed 25433518Cox GR, Callahan P, Churchill R, Hunot V, Merry SN, Parker AG, Hetrick SE. Psychological therapies versus antidepressant medication, alone and in combination for depression in children and adolescents. Cochrane Database Syst Rev. 2014 Nov 30;2014(11):CD008324. doi: 10.1002/14651858.CD008324.pub3.
- Background: PubMed 18444054David-Ferdon C, Kaslow NJ. Evidence-based psychosocial treatments for child and adolescent depression. J Clin Child Adolesc Psychol. 2008 Jan;37(1):62-104. doi: 10.1080/15374410701817865.
- Background: PubMed 22156932Eapen V, Crncec R. Strategies and challenges in the management of adolescent depression. Curr Opin Psychiatry. 2012 Jan;25(1):7-13. doi: 10.1097/YCO.0b013e32834de3bd.
- BackgroundFernández, O., Pérez, C., Gloger, S., Krause, M., (2015) Importancia de los cambios iniciales en psicoterapia con jovenes, Terapia Psicológica, (33)3, pp. 247 - 255.
- BackgroundFernández, O. M., Herrera-Salinas, P. & Escobar-Martínez, M. J. (2016). youthes en Psicoterapia: Su Representación de la Relación Terapéutica. Revista Latinoamericana de Ciencias Sociales, Niñez y Juventud, 14 (1), pp. 559-575.
- BackgroundFernandez, O.M., Krause, M., & Pérez, J.C. (2016). Therapeutic alliance in the initial phase of psychotherapy with ado- lescents: different perspectives and their association with therapeutic outcomes. Research in Psychotherapy: Psychopathology, Process and Outcome, 19(1), 1-9. doi: 10.4081/ripppo.2016.180
- Background: PubMed 28394249Goodyer IM, Reynolds S, Barrett B, Byford S, Dubicka B, Hill J, Holland F, Kelvin R, Midgley N, Roberts C, Senior R, Target M, Widmer B, Wilkinson P, Fonagy P. Cognitive-behavioural therapy and short-term psychoanalytic psychotherapy versus brief psychosocial intervention in adolescents with unipolar major depression (IMPACT): a multicentre, pragmatic, observer-blind, randomised controlled trial. Health Technol Assess. 2017 Mar;21(12):1-94. doi: 10.3310/hta21120.
- BackgroundHatcher, R., & Gillaspy, J., (2006) Development and validation of a revised short version of the working alliance inventory, Psychotherapy Research, 16:1, 12-25, DOI: 10.1080/10503300500352500
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMA prompting for patients and PDF Reports for therapists in people with Depressive Symptoms, run by Vania Martínez-Nahuel at 1 site in Chile.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 23 May 2022. 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 Chile. 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 was stopped early (reason given: The study was terminated early due to the difficulty in recruiting cases during a pandemic period.). Results are not available in the source record.
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?
Working Alliance Inventory, Patient Form (WAI-P) (time frame: Immediately after the end of first three psychotherapy sessions.). 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 NCT04830527, which also lists 32 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 23 May 2022.