"Mamá, te Entiendo" App-based Intervention for Reducing Depressive Symptoms in Postpartum Women

NCT05643898 | Unknown DMC

• 1 other identifier: 210824004
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Minor Depressive Disorder; Major Depressive Disorder; Post Partum Depression

Keywords

e-health; postpartum depression; guided; internet-based

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  T1 (post test: 8 weeks)

• Participants' adherence to the intervention

  Percentage of participants who completed all main modules.

  T1 (post test: 8 weeks)

• Participants' usability of the intervention

  Average, range, and standard deviation of the number of main modules completed.

  T1 (post test: 8 weeks)

• Participants' adherence to the homework exercises

  Average, range, and standard deviation of homework exercises sent to the e-coach.

  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.

  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.

  After T2 (follow-up: 12 weeks)

• Resources needed to complete the intervention

  Length of time required for e-coaches to deliver the intervention.

  Through the study, in average 8 months

Secondary Outcomes (8)

• Change in depression diagnosis

  T0 (Baseline), T1 (post test: 8-weeks) and T2 (follow-up: 12-weeks)

• Change in depressive symptoms

  T0 (Baseline), T1 (post test: 8-weeks) and T2 (follow-up: 12-weeks)

• Change in postpartum depressive symptoms

  T0 (Baseline), T1 (post test: 8-weeks) and T2 (follow-up: 12-weeks)

• Change in perceived social support

  T0 (Baseline) and T2 (follow-up: 12-weeks)

• Change in mother-infant bonding

  T0 (Baseline) and T2 (follow-up: 12-weeks)

Study Arms (2)

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.

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.

Interventions

Mamá, te entiendo (Mom, I get you) BEHAVIORAL

"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.

Mamá, te entiendo (Mom, I get you)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Agencia Nacional de Investigación y Desarrollo: collaborator
• Instituto Milenio para Investigación en Depresión y Personalidad: collaborator

MeSH Terms

Conditions

Depressive Disorder, Major; Depression, Postpartum

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Pamela Franco

CONTACT

+56999690230; pvfranco@uc.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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. Outcome interviews will be conducted by clinical psychologists that will be masked for the condition. It is not possible to mask personnel and participants to the treatment allocation because of the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 9, 2022
• Study Start: March 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: December 9, 2022

Record last verified: 2022-12