Clinical trial NCT06965270: Woman Mental Health and Addictions on Pregnancy
Official title: Woman Mental Health and Addictions on Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Mental Disorder
Substance Abuse
Keywords: Mental Health
Substance abuse
smoking
Dual disorders
Pregnancy
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
Collaborators: name: Plan Nacional sobre Drogas
First posted: 2025-05-11
Enrollment: 2014
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Depression symptoms
timeFrame: 12 months after enrollment
measure: Anxiety symptoms
timeFrame: 12 months after enrollment
measure: Post-Traumatic Stress Disorder symptoms
timeFrame: 12 months after enrollment
measure: Alcohol Use Disorders
timeFrame: 12 months after enrollment
measure: Drug Abuse Disorders
timeFrame: 12 months after enrollment
measure: Smoking Dependence
timeFrame: 12 months after enrollment
measure: Substance use intensity
timeFrame: 12 months after enrollment
Secondary outcomes:
measure: Obstetric outcomes (Gestational week at birth)
timeFrame: 12 months after enrollment
measure: Obstetric outcomes (route of delivery)
timeFrame: 12 months after enrollment
measure: Obstetric outcomes (puerperal complications )
timeFrame: 12 months after enrollment
measure: Child Perinatal outcomes (Fetal birth weight)
timeFrame: 12 months after enrollment
measure: Child Perinatal outcomes (Apgar score)
timeFrame: 12 months after enrollment
measure: Child Perinatal outcomes (Arterial pH)
timeFrame: 12 months after enrollment
measure: Child Perinatal outcomes (resuscitation)
timeFrame: 12 months after enrollment
Other outcomes:
Locations:
Study officials:
References: