Clinical trial NCT05643898: "Mamá, te Entiendo" App-based Intervention for Reducing Depressive Symptoms in Postpartum Women
Official title: Feasibility and Acceptability Study of "Mamá, te Entiendo": an App-based Intervention for Reducing Depressive Symptoms in Postpartum Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Minor Depressive Disorder
Major Depressive Disorder
Post Partum Depression
Keywords: e-health
postpartum depression
guided
internet-based
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Agencia Nacional de Investigación y Desarrollo
name: Instituto Milenio para Investigación en Depresión y Personalidad
First posted: 2022-12-09
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

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,
* 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).

Exclusion Criteria:

Participants exclusion criteria will be the following: illiteracy, risk of suicide, alcohol or substance abuse, bipolar disorder, and psychotic disorder.

Primary outcomes:
measure: Intervention's acceptability by credibility/expectancy
timeFrame: T0: baseline
measure: Satisfaction with the intervention
timeFrame: T1 (post test: 8 weeks)
measure: Participants' adherence to the intervention
timeFrame: T1 (post test: 8 weeks)
measure: Participants' usability of the intervention
timeFrame: T1 (post test: 8 weeks)
measure: Participants' adherence to the homework exercises
timeFrame: T1 (post test: 8 weeks)
measure: Engagement with the intervention
timeFrame: T1 (post test: 8 weeks)
measure: Intervention's acceptability by participant's experience
timeFrame: After T2 (follow-up: 12 weeks)
measure: Resources needed to complete the intervention
timeFrame: Through the study, in average 8 months
Secondary outcomes:
measure: Change in depression diagnosis
timeFrame: T0 (Baseline), T1 (post test: 8-weeks) and T2 (follow-up: 12-weeks)
measure: Change in depressive symptoms
timeFrame: T0 (Baseline), T1 (post test: 8-weeks) and T2 (follow-up: 12-weeks)
measure: Change in postpartum depressive symptoms
timeFrame: T0 (Baseline), T1 (post test: 8-weeks) and T2 (follow-up: 12-weeks)
measure: Change in perceived social support
timeFrame: T0 (Baseline) and T2 (follow-up: 12-weeks)
measure: Change in mother-infant bonding
timeFrame: T0 (Baseline) and T2 (follow-up: 12-weeks)
measure: Change in satisfaction and self-efficacy regarding motherhood
timeFrame: T0 (Baseline) and T2 (follow-up: 12-weeks)
measure: Mental Healthcare Services Use from T0 to T1
timeFrame: T1 (post test: 8-weeks)
measure: Mental Healthcare Services Use from T1 to T2
timeFrame: T2 (follow-up: 12-weeks)
Other outcomes:
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