Minor Depressive DisorderNCT05643898
"Mamá, te Entiendo" App-based Intervention for Reducing Depressive Symptoms in Postpartum Women
A study testing Mamá, te entiendo (Mom, I get you) in people with Minor Depressive Disorder and Major Depressive Disorder, run by Pontificia Universidad Catolica de Chile.
Trial summary
Title: "Feasibility and acceptability study of "Mamá, te entiendo": an app-based intervention for reducing depressive symptoms in postpartum women" Funding: This work was funded by the Chilean National Agency of Research and Development (ANID Doctorado Nacional 2019 - 21190745). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Minor Depressive Disorder, Major Depressive Disorder, Post Partum Depression
- What is being tested?
- Mamá, te entiendo (Mom, I get you)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Nov 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women will be included if they:
- have a < 6-month-old baby,
- have a PHQ-9 (Kroenke et al., 2001; Diez-Quevedo et al., 2001) score ≥ 5 points,
- have minor or major depression according to the Mini-International Neuropsychiatric Interview (MINI: Sheehan et al., 1999; Ferrando et al., 2000),
- are at least 18 years old,
- are Chilean residents,
Show all 10Show fewer
- are fluent in written and spoken Spanish,
- self-report ownership of a smartphone, and
- self-report regular access to the internet.
- Minor depression will be defined as the presence of two to four concurrent symptoms of depressive disorder (one of which is depressed mood or anhedonia) present most or all the time for at least two weeks, with symptoms causing dysfunction and negative impact on the individual's life (American Psychiatric Association, 2013). Major depression will be defined as the presence of five or more concurrent symptoms of depressive disorder (one of which is depressed mood or anhedonia) present most or all the time for at least two weeks, with symptoms causing dysfunction and a negative impact on the individual's life (American Psychiatric Association, 2013).
Who cannot join
- Participants exclusion criteria will be the following: illiteracy, risk of suicide, alcohol or substance abuse, bipolar disorder, and psychotic disorder.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility and Acceptability Study of "Mamá, te Entiendo": an App-based Intervention for Reducing Depressive Symptoms in Postpartum Women
Title: "Feasibility and acceptability study of "Mamá, te entiendo": an app-based intervention for reducing depressive symptoms in postpartum women"
Funding: This work was funded by the Chilean National Agency of Research and Development (ANID Doctorado Nacional 2019 - 21190745).
Read more
General objective: To assess the feasibility and acceptability of a guided 8-week cognitive-behavioral app-based intervention for Chilean postpartum women with depressive symptoms.
Design: A small-scale parallel 2-arms trial will be conducted. Postpartum women with minor or major depression will be randomized to the app-based intervention or waitlist. The primary outcomes are feasibility and acceptability variables, mainly; recruitment and eligibility rates, intervention and study adherence, and participants' intervention satisfaction, use, and engagement. Semi-structured interviews with a sub-sample will provide more information about the participants' experience with the intervention. Women's depression diagnostic status will be assessed at pre-treatment, post-treatment, and 1-month follow-up. Other secondary outcomes will include participants' perceived social support, mother-infant bonding, and maternal satisfaction and self-efficacy.
Read the detailed description
Background
Chile has a high prevalence of postpartum depression and a significant treatment gap. Some barriers to postpartum depression care uncover the need for more easily accessible and lower-cost interventions. Chile's high utilization of digital technologies across all social strata and the increased use of pregnancy and parenting apps open the possibility of delivering interventions through mobile devices. Cognitive-behavioral internet-based interventions have proven to be effective in reducing symptoms of depression in high-income countries. However, in Chile, this is an underdeveloped field. This trial aims to examine the feasibility and acceptability of a guided 8-week cognitive-behavioral app-based intervention for Chilean postpartum women with depressive symptoms.
Methods and design
Study Design
This is a mixed-methods feasibility and acceptability study of an app-based intervention for reducing postpartum depression symptoms. A two-arm, small-scale randomized controlled trial will be conducted with postpartum women with minor or major depression. Women will be randomly assigned to the intervention group (internet-based intervention: "Mamá, te entiendo" /"Mom, I get you") or the control group (waitlist: WL). The three primary data collection points for study participants in the intervention group and WL group are as follows: baseline (pre-treatment: T0), post-treatment (8 weeks from randomization: T1), and 1-month follow-up (12 weeks from randomization: T2). A sample size of 33 participants per group was set. A qualitative evaluation will be conducted to have more knowledge about participants' perspectives on the intervention and study procedures.
Recruitment
Recruitment will be conducted online through advertisements on social media platforms. The ads will include general information on the study aims and inclusion criteria and will be linked to a web-based depression symptomatology assessment. Potential participants will be contacted for further eligibility assessment. No incentives for participation will be provided so that the endpoint of participant acceptability will not be confounded.
Randomization
Women who meet inclusion criteria will be randomized to "Mamá, te entiendo" or WL. An independent person not involved in the study will generate the allocation sequence. Stratified randomization will be conducted according to depressive symptom severity. Researchers will be blind to the randomization process and will be notified through email regarding participant allocation by an independent researcher. Once randomized, participants and research personnel will not be blinded to group condition. Following the notification, participants will be contacted over the telephone to inform them of their assigned group (i.e., intervention or WL). The intervention group will receive instructions for registering into the app.
Intervention Condition: "Mamá, te entiendo" ("Mom, I get you")
Participants in this condition will receive a guided, app-based, cognitive-behavioral, 8-week intervention for postpartum depression symptoms. It also includes some elements from attachment and mentalization theories. "Mamá, te entiendo" was developed based on the CeHRes Roadmap through a participatory process that involved continuous evaluation cycles. Ten focus groups were conducted with perinatal women and healthcare professionals, and five usability interviews with potential end users. "Mamá, te entiendo" consists of the following sections :
- Main and optional modules. The intervention consists of six main sequential modules and three optional modules. The main modules address the following: Psychoeducation on depression, How the cognitive-behavioral approach works, Identifying thinking errors, Cognitive restructuring, Problem-solving, and Behavioral activation. The optional modules address: Psychoeducation on anxiety, Exposure strategies, and Communicational Skills. Five case examples of mothers illustrate depressive symptoms and techniques. There is also an introductory module describing the app's functioning (without therapeutic content), and a guide about maintaining changes is displayed when the last main module is completed.
- Homework exercises (Workbook). All modules except the two psychoeducational ones include homework. All homework exercises can be accessed through a specific section in the app called "Workbook". Participants will receive feedback from an e-coach. They also can contact the e-coach to solve doubts about the app content and exercises. The e-coaching protocol of the Caring Universities Project was adapted for this intervention.
- Infographics. Another section of the app includes infographics about other relevant topics: 1) Guide to healing, 2) How to strengthen the support network, 3) Postpartum rage, 4) The postpartum body, 5) Dealing with doubts/comparison/over information, 6) Mentalizing my baby, 7) The couple's relationship in the postpartum period, 8) Returning to work after the maternity leave.
- Reading for the support network. A shareable document with reading about how to support a loved one struggling with depression symptoms is included.
- Resources section. A resources section includes links to websites and documents of interest.
WL Condition
Participants in the WL condition will receive the same assessments as those in the intervention condition. Participants allocated to WL may access their local mental health services during their waiting period. In Chile, patients diagnosed with depression by a general practitioner have guaranteed access to treatment at low or no cost. Treatment varies according to depression severity, with group or individual therapy, alone or combined with pharmacotherapy. After the follow-up assessment, the WL group will be offered access to the intervention.
Data collection
All data will be collected online via video call (interviews) or web platform (self-report questionnaires). Semi-structured acceptability interviews will be recorded and transcribed.
Analyses
The primary outcomes are feasibility and acceptability variables, mainly; recruitment and eligibility rates, intervention and study adherence, and participants' intervention satisfaction, use, and engagement. Secondary outcomes include depression symptomatology and diagnosis, perceived social support, mother-infant bonding, and maternal satisfaction and self-efficacy.
Descriptive statistics will be reported, including the means and standard deviations (SDs) or medians and interquartile ranges for each questionnaire at T0, T1, and T2.
For preliminary efficacy, data will be analyzed following CONSORT guidelines; between-group comparisons will be by intention-to-treat. Comparison between groups will use repeated measures analysis of covariance (ANCOVA) with adjustment for baseline in a random-effects model. Interaction between time and group will be assessed (for changes in group effects with time), and, in the absence of such an interaction, the overall difference between groups across the two follow-up assessments will be calculated (95% CIs and p values).
The qualitative data from the interviews will be analyzed by two independent coders using thematic analysis. Themes will be identified, described, and subsequently categorized.
- Being tested
- Mamá, te entiendo (Mom, I get you)
- Keywords
- e-health, postpartum depression, guided, internet-based
- Medical subject headings
- Depressive Disorder, Major, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mamá, te entiendo (Mom, I get you)Behavioural
"Mamá, te entiendo" is a guided 8-week cognitive-behavioral app-based intervention that targets postpartum women with minor and major depression. The development of the intervention followed the "CeHRes Roadmap". It includes some elements from attachment and mentalization theories.
The intervention consists of six main sequential modules and three optional modules. All modules except the two psychoeducational ones include homework. Participants will receive feedback from an e-coach. They also can contact the e-coach to solve doubts about the app content and exercises. Other sections of the app include infographics about other relevant topics (for example, How to strengthen the couple relationship), a shareable document with reading about how to support a loved one struggling with depression and a resources section with links to websites and documents of interest.
| Study group | Role | What they receive |
|---|---|---|
| Mamá, te entiendo (Mom, I get you) | Experimental | Participants assigned to this arm will receive a guided 8-week cognitive-behavioral app-based intervention for reducing postpartum depressive symptoms. Receives: Behavioral: Mamá, te entiendo (Mom, I get you) |
| Waitlist | No intervention | Participants in the WL condition will receive the same assessments as those in the intervention condition. Participants allocated to WL may access their local mental health services during their waiting period. In Chile, patients diagnosed with depression by a general practitioner have guaranteed access to treatment at low or no cost. Treatment varies according to depression severity, with group or individual therapy, alone or combined with pharmacotherapy. After the follow-up assessment, the WL group will be offered access to the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention's acceptability by credibility/expectancy
The CEQ is used to assess treatment credibility and expectancy of benefit. The CEQ is a 6-item self-report questionnaire that measures treatment credibility, defined as "how believable, convincing, and logical the treatment is" and expectancy, defined as "improvements the client believes will be achieved". Scores range from 0 to 100 with higher scores indicating higher acceptability of the intervention. Therefore, higher scores mean better outcomes.
Measured: T0: baseline
Satisfaction with the intervention
The Client Satisfaction Questionnaire is used to assess satisfaction with the intervention. It is an 8-item self-report questionnaire that assesses the general level of satisfaction with a service received. The total score ranges from 8 to 32. Higher score indicates greater satisfaction.
Measured: T1 (post test: 8 weeks)
Participants' adherence to the intervention
Percentage of participants who completed all main modules.
Measured: T1 (post test: 8 weeks)
Participants' usability of the intervention
Average, range, and standard deviation of the number of main modules completed.
Measured: T1 (post test: 8 weeks)
Participants' adherence to the homework exercises
Average, range, and standard deviation of homework exercises sent to the e-coach.
Measured: T1 (post test: 8 weeks)
Engagement with the intervention
Engagement with the intervention is assess by the TWEETS. The TWEETS is a 9-item self-report measure that assesses engagement with an eHealth technology. Of the nine items, three are aimed at assessing behavioral engagement, three at cognitive engagement, and three at affective engagement. Each item is measured on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree". The total score ranges from 0 to 36. Higher scores indicate greater engagement.
Measured: T1 (post test: 8 weeks)
Intervention's acceptability by participant's experience
A sub-sample of participants from the intervention group will be invited to participate in semi-structured interviews. The interviews will explore positive and negative impressions and general experiences with the intervention and study procedures. The interviews will be analysed through thematic analysis.
Measured: After T2 (follow-up: 12 weeks)
Resources needed to complete the intervention
Length of time required for e-coaches to deliver the intervention.
Measured: Through the study, in average 8 months
Secondary outcomes (8)
Change in depression diagnosis
The Spanish version of the Mini-international neuropsychiatric interview will be used to assess eligibility (diagnosis of minor or major depression) and as an outcome measure. At T1 and T2, only the "Major Depressive Episode" section will be used.
Participants fulfilling five out of nine depressive symptoms for at least 2 weeks (with at least one symptom as depressed mood or loss of interest) will be diagnosed as having major depressive disorder. Those fulfilling two to four of the nine symptoms (with at least one symptom being depressed mood or loss of interest) will be diagnosed with minor depressive disorder. Those with less than two symptoms will be diagnosed as in remission.
Measured: T0 (Baseline), T1 (post test: 8-weeks) and T2 (follow-up: 12-weeks)
Change in depressive symptoms
The Patient Health Questionnaire -9 is used to meassure depressive symptoms. The PHQ-9 is a 9-item self-report measure of depressive symptoms experienced over the past two weeks. It is based on the Diagnostic Statistical Manual, fourth edition diagnostic criteria for major depressive disorder. Participants rate the frequency of symptoms (e.g., 'Feeling down, depressed, or hopeless') on a 4-point scale ranging from "not at all" to "nearly every day". Total scores range from 0 (no symptoms) to 27 (severe). Scores > 9 are indicative of a clinically significant level of depressive symptoms.
Measured: T0 (Baseline), T1 (post test: 8-weeks) and T2 (follow-up: 12-weeks)
Change in postpartum depressive symptoms
The Edinburgh Postpartum Depression Scale is used to assess postpartum depressive symptoms. It consists of ten multiple-choice questions on a 4-point scale ranging from 0 to 3 according to the severity of the symptoms. The total score goes from 0 (no symptoms) to 30 (severe symptoms). It has been validated in various countries and cultures, including Chile. Higher scores indicate more significant depressive symptoms, and three categories of depressive symptomatology are identified: no risk, probable risk, and probable depression.
Measured: T0 (Baseline), T1 (post test: 8-weeks) and T2 (follow-up: 12-weeks)
Change in perceived social support
The Multidimensional Scale of Perceived Social Support is used to measure perceived social support. It is a 12-item measure of perceived adequacy of social support from three sources: family, friends, and significant other. It was translated and validated in Chile. In the Chilean version, the questions are rated on a 4-point scale ranging from "rarely" to "always". Higher score indicates greater perceived social support.
Measured: T0 (Baseline) and T2 (follow-up: 12-weeks)
Change in mother-infant bonding
The Postpartum Bonding Questionnaire is used to measure mother-infant bonding. It is a 25-item self-report measure that assesses mother-infant bonding through the mother's feelings and attitudes toward her infant. The questions are rated on a 6-point Likert scale ranging from "not at all" to "always". A validated Spanish version of the PBQ will be used in this study. The total score ranges from 0 to 75. Higher score indicates greater mother-infant bonding.
Measured: T0 (Baseline) and T2 (follow-up: 12-weeks)
Change in satisfaction and self-efficacy regarding motherhood
The Escala de Evaluación Parental [Parental Assessment Scale] is used to measure satisfaction and self-efficacy regarding motherhood. It is a 10-item self-report measure that assesses satisfaction and self-efficacy regarding motherhood in women with children between 0 and 2 years of age. Each item is measured on a 10-point Likert-type scale, ranging from "totally Disagree" to "totally agree"). The scale was developed and validated in Chile. The total score ranges from 0 to 10. Higher score indicates greater satisfaction and self-efficacy regarding motherhood.
Measured: T0 (Baseline) and T2 (follow-up: 12-weeks)
Mental Healthcare Services Use from T0 to T1
Participants will be asked if they have use mental health services since T0 (baseline), i.e., whether the participant is currently undergoing any treatment (pharmacotherapy/psychotherapy/both/none).
Measured: T1 (post test: 8-weeks)
Mental Healthcare Services Use from T1 to T2
Participants will be asked if they have use mental health services since T1 (post test), i.e., whether the participant is currently undergoing any treatment (pharmacotherapy/psychotherapy/both/none).
Measured: T2 (follow-up: 12-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Mar 2023 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minor 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
- Model description
- The present study is a two-armed randomized controlled trial. A guided app-based intervention to reduce depressive symptoms and prevent major depression onset ("Mamá, te entiendo") will be compared to waitlist.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo, Instituto Milenio para Investigación en Depresión y Personalidad
- Responsible party
- Principal investigator, Pamela Franco, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643898
- Sponsor's protocol ID
- 210824004
- Status last verified
- Dec 2022
- First submitted
- 22 Nov 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability Study of "Mamá, te Entiendo": an App-based Intervention for Reducing Depressive Symptoms in Postpartum Women
- ClinicalTrials.gov ID
- NCT05643898
- Acronym / sponsor ID
- 210824004
- Keywords
- e-health, postpartum depression, guided, internet-based
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo, Instituto Milenio para Investigación en Depresión y Personalidad
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 9 Dec 2022 (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.
Title: "Feasibility and acceptability study of "Mamá, te entiendo": an app-based intervention for reducing depressive symptoms in postpartum women"
Funding: This work was funded by the Chilean National Agency of Research and Development (ANID Doctorado Nacional 2019 - 21190745).
General objective: To assess the feasibility and acceptability of a guided 8-week cognitive-behavioral app-based intervention for Chilean postpartum women with depressive symptoms.
Design: A small-scale parallel 2-arms trial will be conducted. Postpartum women with minor or major depression will be randomized to the app-based intervention or waitlist. The primary outcomes are feasibility and acceptability variables, mainly; recruitment and eligibility rates, intervention and study adherence, and participants' intervention satisfaction, use, and engagement. Semi-structured interviews with a sub-sample will provide more information about the participants' experience with the intervention. Women's depression diagnostic status will be assessed at pre-treatment, post-treatment, and 1-month follow-up. Other secondary outcomes will include participants' perceived social support, mother-infant bonding, and maternal satisfaction and self-efficacy.
Detailed description
Background
Chile has a high prevalence of postpartum depression and a significant treatment gap. Some barriers to postpartum depression care uncover the need for more easily accessible and lower-cost interventions. Chile's high utilization of digital technologies across all social strata and the increased use of pregnancy and parenting apps open the possibility of delivering interventions through mobile devices. Cognitive-behavioral internet-based interventions have proven to be effective in reducing symptoms of depression in high-income countries. However, in Chile, this is an underdeveloped field. This trial aims to examine the feasibility and acceptability of a guided 8-week cognitive-behavioral app-based intervention for Chilean postpartum women with depressive symptoms.
Methods and design
Study Design
This is a mixed-methods feasibility and acceptability study of an app-based intervention for reducing postpartum depression symptoms. A two-arm, small-scale randomized controlled trial will be conducted with postpartum women with minor or major depression. Women will be randomly assigned to the intervention group (internet-based intervention: "Mamá, te entiendo" /"Mom, I get you") or the control group (waitlist: WL). The three primary data collection points for study participants in the intervention group and WL group are as follows: baseline (pre-treatment: T0), post-treatment (8 weeks from randomization: T1), and 1-month follow-up (12 weeks from randomization: T2). A sample size of 33 participants per group was set. A qualitative evaluation will be conducted to have more knowledge about participants' perspectives on the intervention and study procedures.
Recruitment
Recruitment will be conducted online through advertisements on social media platforms. The ads will include general information on the study aims and inclusion criteria and will be linked to a web-based depression symptomatology assessment. Potential participants will be contacted for further eligibility assessment. No incentives for participation will be provided so that the endpoint of participant acceptability will not be confounded.
Randomization
Women who meet inclusion criteria will be randomized to "Mamá, te entiendo" or WL. An independent person not involved in the study will generate the allocation sequence. Stratified randomization will be conducted according to depressive symptom severity. Researchers will be blind to the randomization process and will be notified through email regarding participant allocation by an independent researcher. Once randomized, participants and research personnel will not be blinded to group condition. Following the notification, participants will be contacted over the telephone to inform them of their assigned group (i.e., intervention or WL). The intervention group will receive instructions for registering into the app.
Intervention Condition: "Mamá, te entiendo" ("Mom, I get you")
Participants in this condition will receive a guided, app-based, cognitive-behavioral, 8-week intervention for postpartum depression symptoms. It also includes some elements from attachment and mentalization theories. "Mamá, te entiendo" was developed based on the CeHRes Roadmap through a participatory process that involved continuous evaluation cycles. Ten focus groups were conducted with perinatal women and healthcare professionals, and five usability interviews with potential end users. "Mamá, te entiendo" consists of the following sections :
- Main and optional modules. The intervention consists of six main sequential modules and three optional modules. The main modules address the following: Psychoeducation on depression, How the cognitive-behavioral approach works, Identifying thinking errors, Cognitive restructuring, Problem-solving, and Behavioral activation. The optional modules address: Psychoeducation on anxiety, Exposure strategies, and Communicational Skills. Five case examples of mothers illustrate depressive symptoms and techniques. There is also an introductory module describing the app's functioning (without therapeutic content), and a guide about maintaining changes is displayed when the last main module is completed.
- Homework exercises (Workbook). All modules except the two psychoeducational ones include homework. All homework exercises can be accessed through a specific section in the app called "Workbook". Participants will receive feedback from an e-coach. They also can contact the e-coach to solve doubts about the app content and exercises. The e-coaching protocol of the Caring Universities Project was adapted for this intervention.
- Infographics. Another section of the app includes infographics about other relevant topics: 1) Guide to healing, 2) How to strengthen the support network, 3) Postpartum rage, 4) The postpartum body, 5) Dealing with doubts/comparison/over information, 6) Mentalizing my baby, 7) The couple's relationship in the postpartum period, 8) Returning to work after the maternity leave.
- Reading for the support network. A shareable document with reading about how to support a loved one struggling with depression symptoms is included.
- Resources section. A resources section includes links to websites and documents of interest.
WL Condition
Participants in the WL condition will receive the same assessments as those in the intervention condition. Participants allocated to WL may access their local mental health services during their waiting period. In Chile, patients diagnosed with depression by a general practitioner have guaranteed access to treatment at low or no cost. Treatment varies according to depression severity, with group or individual therapy, alone or combined with pharmacotherapy. After the follow-up assessment, the WL group will be offered access to the intervention.
Data collection
All data will be collected online via video call (interviews) or web platform (self-report questionnaires). Semi-structured acceptability interviews will be recorded and transcribed.
Analyses
The primary outcomes are feasibility and acceptability variables, mainly; recruitment and eligibility rates, intervention and study adherence, and participants' intervention satisfaction, use, and engagement. Secondary outcomes include depression symptomatology and diagnosis, perceived social support, mother-infant bonding, and maternal satisfaction and self-efficacy.
Descriptive statistics will be reported, including the means and standard deviations (SDs) or medians and interquartile ranges for each questionnaire at T0, T1, and T2.
For preliminary efficacy, data will be analyzed following CONSORT guidelines; between-group comparisons will be by intention-to-treat. Comparison between groups will use repeated measures analysis of covariance (ANCOVA) with adjustment for baseline in a random-effects model. Interaction between time and group will be assessed (for changes in group effects with time), and, in the absence of such an interaction, the overall difference between groups across the two follow-up assessments will be calculated (95% CIs and p values).
The qualitative data from the interviews will be analyzed by two independent coders using thematic analysis. Themes will be identified, described, and subsequently categorized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The present study is a two-armed randomized controlled trial. A guided app-based intervention to reduce depressive symptoms and prevent major depression onset ("Mamá, te entiendo") will be compared to waitlist.
| Arm | Type | Receives |
|---|---|---|
| Mamá, te entiendo (Mom, I get you) | Experimental | Behavioral: Mamá, te entiendo (Mom, I get you)Participants assigned to this arm will receive a guided 8-week cognitive-behavioral app-based intervention for reducing postpartum depressive symptoms. |
| Waitlist | No intervention | –Participants in the WL condition will receive the same assessments as those in the intervention condition. Participants allocated to WL may access their local mental health services during their waiting period. In Chile, patients diagnosed with depression by a general practitioner have guaranteed access to treatment at low or no cost. Treatment varies according to depression severity, with group or individual therapy, alone or combined with pharmacotherapy. After the follow-up assessment, the WL group will be offered access to the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- have a < 6-month-old baby,
- have a PHQ-9 (Kroenke et al., 2001; Diez-Quevedo et al., 2001) score ≥ 5 points,
- have minor or major depression according to the Mini-International Neuropsychiatric Interview (MINI: Sheehan et al., 1999; Ferrando et al., 2000),
- are at least 18 years old,
- are Chilean residents,
Key exclusion criteria (1 listed)
- Participants exclusion criteria will be the following: illiteracy, risk of suicide, alcohol or substance abuse, bipolar disorder, and psychotic disorder.
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 |
|---|---|---|
| Mamá, te entiendo (Mom, I get you)"Mamá, te entiendo" is a guided 8-week cognitive-behavioral app-based intervention that targets postpartum women with minor and major depression. The development of the intervention followed the "CeHRes Roadmap". It includes some elements from attachment and mentalization theories. The intervention consists of six main sequential modules and three optional modules. All modules except the two psychoeducational ones include homework. Participants will receive feedback from an e-coach. They also can contact the e-coach to solve doubts about the app content and exercises. Other sections of the app include infographics about other relevant topics (for example, How to strengthen the couple relationship), a shareable document with reading about how to support a loved one struggling with depression and a resources section with links to websites and documents of interest. | Behavioural | Mamá, te entiendo (Mom, I get you) |
Primary outcome
Intervention's acceptability by credibility/expectancy
Time frame: T0: baseline
The CEQ is used to assess treatment credibility and expectancy of benefit. The CEQ is a 6-item self-report questionnaire that measures treatment credibility, defined as "how believable, convincing, and logical the treatment is" and expectancy, defined as "improvements the client believes will be achieved". Scores range from 0 to 100 with higher scores indicating higher acceptability of the intervention. Therefore, higher scores mean better outcomes.
Satisfaction with the intervention
Time frame: T1 (post test: 8 weeks)
The Client Satisfaction Questionnaire is used to assess satisfaction with the intervention. It is an 8-item self-report questionnaire that assesses the general level of satisfaction with a service received. The total score ranges from 8 to 32. Higher score indicates greater satisfaction.
Participants' adherence to the intervention
Time frame: T1 (post test: 8 weeks)
Percentage of participants who completed all main modules.
Participants' usability of the intervention
Time frame: T1 (post test: 8 weeks)
Average, range, and standard deviation of the number of main modules completed.
Participants' adherence to the homework exercises
Time frame: T1 (post test: 8 weeks)
Average, range, and standard deviation of homework exercises sent to the e-coach.
Engagement with the intervention
Time frame: T1 (post test: 8 weeks)
Engagement with the intervention is assess by the TWEETS. The TWEETS is a 9-item self-report measure that assesses engagement with an eHealth technology. Of the nine items, three are aimed at assessing behavioral engagement, three at cognitive engagement, and three at affective engagement. Each item is measured on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree". The total score ranges from 0 to 36. Higher scores indicate greater engagement.
Intervention's acceptability by participant's experience
Time frame: After T2 (follow-up: 12 weeks)
A sub-sample of participants from the intervention group will be invited to participate in semi-structured interviews. The interviews will explore positive and negative impressions and general experiences with the intervention and study procedures. The interviews will be analysed through thematic analysis.
Resources needed to complete the intervention
Time frame: Through the study, in average 8 months
Length of time required for e-coaches to deliver the intervention.
8 secondary outcomes
Change in depression diagnosis
Time frame: T0 (Baseline), T1 (post test: 8-weeks) and T2 (follow-up: 12-weeks)
Change in depressive symptoms
Time frame: T0 (Baseline), T1 (post test: 8-weeks) and T2 (follow-up: 12-weeks)
Change in postpartum depressive symptoms
Time frame: T0 (Baseline), T1 (post test: 8-weeks) and T2 (follow-up: 12-weeks)
Change in perceived social support
Time frame: T0 (Baseline) and T2 (follow-up: 12-weeks)
Change in mother-infant bonding
Time frame: T0 (Baseline) and T2 (follow-up: 12-weeks)
Change in satisfaction and self-efficacy regarding motherhood
Time frame: T0 (Baseline) and T2 (follow-up: 12-weeks)
Mental Healthcare Services Use from T0 to T1
Time frame: T1 (post test: 8-weeks)
Mental Healthcare Services Use from T1 to T2
Time frame: T2 (follow-up: 12-weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
Related trials for Minor Depressive Disorder
Recruiting
Trauma-Focused Cognitive Behavioral Therapy in Unaccompanied Refugee Minors With PTSD in Greece: An RCT
Post-Traumatic Stress Disorder (PTSD), Depressive Symptoms
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.
Questions about this trial
What is this clinical trial studying?
A study testing Mamá, te entiendo (Mom, I get you) in people with Minor Depressive Disorder and Major Depressive Disorder, run by Pontificia Universidad Catolica de 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 10 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pamela Franco (+56999690230, pvfranco@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention's acceptability by credibility/expectancy (time frame: T0: baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2022.