Woman Mental Health and Addictions on Pregnancy

NCT06965270 | Completed

• 1 other identifier: 2015I073
• Study Type: interventional
• Target: 2,014
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pregnancy; Mental Disorder; Substance Abuse

Keywords

Mental Health; Substance abuse; smoking; Dual disorders; Pregnancy

Outcome Measures

Primary Outcomes (7)

• Depression symptoms

  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

  12 months after enrollment

• Anxiety symptoms

  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

  12 months after enrollment

• Post-Traumatic Stress Disorder symptoms

  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.

  12 months after enrollment

• Alcohol Use Disorders

  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.

  12 months after enrollment

• Drug Abuse Disorders

  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.

  12 months after enrollment

• Smoking Dependence

  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.

  12 months after enrollment

• Substance use intensity

  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

  12 months after enrollment

Secondary Outcomes (7)

• Obstetric outcomes (Gestational week at birth)

  12 months after enrollment

• Obstetric outcomes (route of delivery)

  12 months after enrollment

• Obstetric outcomes (puerperal complications )

  12 months after enrollment

• Child Perinatal outcomes (Fetal birth weight)

  12 months after enrollment

• Child Perinatal outcomes (Apgar score)

  12 months after enrollment

Study Arms (3)

Treatment as usual

ACTIVE COMPARATOR

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

Behavioral: Treatment as usual

Telematic intervention

EXPERIMENTAL

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

Behavioral: Internet/App intervention

Standardized clinical intervention

EXPERIMENTAL

Patients in this arm received a standardized telephonic psychotherapeutic intervention.

Behavioral: Standardized clinical intervention

Interventions

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.

Standardized clinical intervention

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.

Telematic intervention

Treatment as usual BEHAVIORAL

Patient will recieve the usual intervention provided by the Health system

Treatment as usual

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead
• Plan Nacional sobre Drogas: collaborator

MeSH Terms

Conditions

Mental Disorders; Substance-Related Disorders; Psychological Well-Being; Smoking

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: May 11, 2025
• Study Start: July 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: May 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share