Skip to main content
OpenTrials
Completed

NCT Number: NCT06965270

Woman Mental Health and Addictions on Pregnancy

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Behavior Chemically-Induced Disorders Mental Disorder Mental Disorders Personal Satisfaction Psychological Well-Being Smoking Substance Abuse Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Two or more positive responses to the AC-OK-Mental Health (AC-OK MH)subscale AND
  • 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
  • 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
  • if the Paykel Suicide Scale was administered, they answered NO to questions 4 and 5.

Exclusion criteria

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

Treatment and study plan

Standardized clinical intervention

Behavioral

This manualized intervention consists of 8 sessions of evidence-based treatments for substance abuse and mental health problems.

Session 1: Introduction, Psychoeducation, Assessment and Safety: Introduces what the patient's clinical assessment suggests about strengths and needs.

Session 2: Relaxation, Mindfulness and cognitive distortions in CBT. Session 3: Getting started in Cognitive Restructuring (CR): thought challenge and action plan.

Session 4: Craving management practice: includes challenging and replacing thoughts that lead to drug and alcohol use.

Session 5: CR practice exercises and motivation: introduction to risk behaviors and triggers for drug and alcohol use. Relapse prevention.

Session 6: Assertiveness and refusal techniques. Session 7: Problem solving, practice and reinforcement: CR skills, relaxation and relapse prevention applied in current circumstances.

Session 8: Care plan and end of program.

Internet/App intervention

Behavioral

Using an already developed Internet/App platform (MeMind), patients will have access to the same therapeutic components as in the standardized intervention arm, arranged in sessions by modules.

Components will be released weekly and reminded via push notifications. Patients will also receive two counseling calls at weeks 1 and 8 to help with technical issues and review problems with the program modules.

Treatment as Usual

Behavioral

Patient will recieve the usual intervention provided by the Health system

Primary outcomes

  1. Depression symptoms

    Time frame: 12 months after enrollment

    Changes in the following scale were measured at 2,4,8,and 12 months:

    • Patient Health Questionnaire (PHQ-9) which addresses the nine DSM-IV diagnostic criteria for major depressive disorder. The range of scores goes from 0 to 27 points depending on the severity

  2. Anxiety symptoms

    Time frame: 12 months after enrollment

    Changes in the following scale were measured at 2,4,8,and 12 months:

    • General Anxiety Disorder 7-item screener (GAD-7) for anxiety . The range of scores goes from 0 to 21 points depending on the severity

  3. Post-Traumatic Stress Disorder symptoms

    Time frame: 12 months after enrollment

    Changes in the following scale were measured at 2,4,8,and 12 months:

    • Post-Traumatic Stress Disorder Checklist (PCL-5), a self-report measure for the 17 DSM-IV symptoms of PTSD. Scores above 33 are considered at risk.

  4. Alcohol Use Disorders

    Time frame: 12 months after enrollment

    Changes in the following scale were measured at 2,4,8,and 12 months:

    Alcohol Use Disorders Identification Test (AUDIT), a screener developed by the World Health Organization (WHO). Patients with scores greater than or equal to 3 are considered at risk.

  5. Drug Abuse Disorders

    Time frame: 12 months after enrollment

    Changes in the following scale were measured at 2,4,8,and 12 months:

    Drug Abuse Screening Test (DAST), a brief self-report instrument designed for drug abuse and dependence disorders detection. Patients with scores greater than or equal to 3 are considered at risk.

  6. Smoking Dependence

    Time frame: 12 months after enrollment

    Changes in the following scale were measured at 2,4,8,and 12 months:

    Fagerström Test for Nicotine Dependence: A six item instrument that evaluates the amount of cigarette consumption, compulsion to smoke, and smoking dependence. The range of scores goes from 0 to 10 points depending on the dependence degree.

  7. Substance use intensity

    Time frame: 12 months after enrollment

    At 2,4,8,and 12 months, women were asked about the number of days in the last month they used the following substances: alcohol, opioids, barbiturates, benzodiazepines, cocaine, amphetamines, cannabis, hallucinogens and inhalants

Secondary outcomes

  1. Obstetric outcomes (Gestational week at birth)

    Time frame: 12 months after enrollment

    After birth, we measured the gestational week at the time of birth (number of weeks)

  2. Obstetric outcomes (route of delivery)

    Time frame: 12 months after enrollment

    After birth, we evaluated the route of delivery (euthocic vaginal or instrumental delivery or cesarean section) and the reason for the indication of cesarean section.

  3. Obstetric outcomes (puerperal complications )

    Time frame: 12 months after enrollment

    After birth, we evaluated the presence of puerperal complications (Yes/no)

  4. Child Perinatal outcomes (Fetal birth weight)

    Time frame: 12 months after enrollment

    After birth, we measured fetal birth weight (gr)

  5. Child Perinatal outcomes (Apgar score)

    Time frame: 12 months after enrollment

    After birth, we measured Apgar score, assessed at one and five minutes.

  6. Child Perinatal outcomes (Arterial pH)

    Time frame: 12 months after enrollment

    After birth, we measured Arterial pH

  7. Child Perinatal outcomes (resuscitation)

    Time frame: 12 months after enrollment

    After birth, we measured the Need (Yes/no) and type of resuscitation (0-V)

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Other

Collaborators

  • Plan Nacional sobre Drogas

Registry information

Acronym: WOMAP

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
May 11, 2025
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.