Feasibility and Acceptability Study of "Mamá, te Entiendo": an App-based Intervention for Reducing Depressive Symptoms in Postpartum Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 66
- Primary Endpoint
- Satisfaction with the intervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Mamá, te entiendo (Mom, I get you) (Behavioral)
Waitlist
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.
Outcomes
Primary 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.
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.
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.
Secondary Outcomes
- 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))
- Change in satisfaction and self-efficacy regarding motherhood(T0 (Baseline) and T2 (follow-up: 12-weeks))
- Mental Healthcare Services Use from T0 to T1(T1 (post test: 8-weeks))
- Mental Healthcare Services Use from T1 to T2(T2 (follow-up: 12-weeks))
Investigators
Pamela Franco
Principal Investigator
Pontificia Universidad Catolica de Chile