Woman Mental Health and Addictions on Pregnancy (WOMAP)

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Status: Completed

Conditions: Mental Disorder; Substance Abuse; Pregnancy

Treatments: Behavioral: Treatment as usual; Behavioral: Internet/App intervention; Behavioral: Standardized clinical intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06965270

2015I073

Details and patient eligibility

About

The study intend to achieve the following objectives

Objective 1: Develop a collaborative infrastructure among different hospital services to support research that improves the accessibility, quality, and outcomes of integrated mental health services for pregnant women for tobacco, benzodiazepine, and other substance use and/or mental health problems.

Objective 2: To evaluate the effect and test the application of computer/smart phone based tools that can assist in the goal of achieving broader effect, improved accessibility and outcomes of substance abuse/mental health services in at-risk populations.

Objective 3: Conduct research on mental health services that: (a) emphasize rapid screening and referral; (b) test the feasibility, acceptability, and effectiveness of two different comprehensive behavioral treatment approaches (standardized clinical intervention and smart phone/computer-based intervention) for pregnant women with tobacco, benzodiazepine, and other substance use problems and mental health disorders; and (c) measure and decrease the obstetric, pediatric, and mental health consequences of these problems on the mother and child.

To achieve these objectives, investigators propose a system of evaluation and recruitment of patients in five Gynecology Departments that annually attend 3700 deliveries. A telematic intervention system based on a platform that we have used for other studies (Memind) and finally a randomized blinded clinical trial of 3 branches with 100 patients per branch (usual treatment, telematic intervention and standardized clinical intervention).

Enrollment: 2,014 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Two or more positive responses to the AC-OK-Mental Health (AC-OK MH)subscale AND
2. One or more positive responses to the AC-OK-Substance Abuse (AC-OK SA) subscale and/or reported smoking more than once a month AND
3. No use of specialized services, defined as not having an appointment in the following month and have not seen a clinician in the past three months and
4. if the Paykel Suicide Scale was administered, they answered NO to questions 4 and 5.

Exclusion criteria

1. Had received a diagnosis of psychotic or bipolar-related disorders or
2. Lacked capacity to consent, as determined by not being able to answer questions of the study purpose or process.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,014 participants in 3 patient groups

Treatment as usual

Active Comparator group

Description:

Patients in this arm received the usual treatment provided by the health system

Treatment:

Behavioral: Treatment as usual

Telematic intervention

Experimental group

Description:

Patients in this arm received an App/internet-based psychotherapeutic intervention.

Treatment:

Behavioral: Internet/App intervention

Standardized clinical intervention

Experimental group

Description:

Patients in this arm received a standardized telephonic psychotherapeutic intervention.

Treatment:

Behavioral: Standardized clinical intervention