PregnancyWOMAPNCT06965270
Woman Mental Health and Addictions on Pregnancy
A study testing Standardized clinical intervention, Internet/App intervention and Treatment as usual in people with Pregnancy and Mental Disorder, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Mental Disorder, Substance Abuse
- What is being tested?
- Standardized clinical intervention, Internet/App intervention and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,014 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read more
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
- Being tested
- Standardized clinical intervention, Internet/App intervention, Treatment as usual
- Keywords
- Mental Health, Substance abuse, smoking, Dual disorders, Pregnancy
- Medical subject headings
- Mental Disorders, Substance-Related Disorders, Psychological Well-Being, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized clinical interventionBehavioural
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 interventionBehavioural
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 usualBehavioural
Patient will recieve the usual intervention provided by the Health system
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | Patients in this arm received the usual treatment provided by the health system Receives: Behavioral: Treatment as usual |
| Telematic intervention | Experimental | Patients in this arm received an App/internet-based psychotherapeutic intervention. Receives: Behavioral: Internet/App intervention |
| Standardized clinical intervention | Experimental | Patients in this arm received a standardized telephonic psychotherapeutic intervention. Receives: Behavioral: Standardized clinical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 months after enrollment
Secondary outcomes (7)
Obstetric outcomes (Gestational week at birth)
After birth, we measured the gestational week at the time of birth (number of weeks)
Measured: 12 months after enrollment
Obstetric outcomes (route of delivery)
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.
Measured: 12 months after enrollment
Obstetric outcomes (puerperal complications )
After birth, we evaluated the presence of puerperal complications (Yes/no)
Measured: 12 months after enrollment
Child Perinatal outcomes (Fetal birth weight)
After birth, we measured fetal birth weight (gr)
Measured: 12 months after enrollment
Child Perinatal outcomes (Apgar score)
After birth, we measured Apgar score, assessed at one and five minutes.
Measured: 12 months after enrollment
Child Perinatal outcomes (Arterial pH)
After birth, we measured Arterial pH
Measured: 12 months after enrollment
Child Perinatal outcomes (resuscitation)
After birth, we measured the Need (Yes/no) and type of resuscitation (0-V)
Measured: 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study startJul 2016
- Primary completionDec 2019
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 2,014 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- Plan Nacional sobre Drogas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965270
- Sponsor's protocol ID
- 2015I073
- Acronym
- WOMAP
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Carmona Camacho R, Lopez Carpintero N, Barrigon ML, Albarracin Garcia L, Barahona I, Baca-Garcia E, Ruiz Nogales C, Menendez I, Sanchez Alonso M, Vidal Marino C, Rodriguez Blanco L, Campos Soler SM, Diaz Rosell M, Le Cook B, Alegria M, Caro Canizares I. Evaluation of an e-health integrated intervention for pregnant women with co-occurring mental health and substance use symptoms: an exploratory randomized clinical trial. BMC Pregnancy Childbirth. 2026 Jun 20. doi: 10.1186/s12884-026-09436-z. Online ahead of print.
PubMed 42321702Lopez Carpintero N, Caro-Canizares I, Barrigon ML, Giraldez-Garcia C, Carmona Camacho R. Impact of the severity of maternal depression, anxiety, and post-traumatic stress disorder, as well as alcohol consumption, on perinatal outcomes. BMC Pregnancy Childbirth. 2026 Apr 30;26(1):511. doi: 10.1186/s12884-026-09179-x.
PubMed 42062994
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Woman Mental Health and Addictions on Pregnancy
- ClinicalTrials.gov ID
- NCT06965270
- Acronym / sponsor ID
- WOMAP / 2015I073
- Conditions
- Pregnancy, Mental Disorder, Substance Abuse
- Keywords
- Mental Health, Substance abuse, smoking, Dual disorders, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,014 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- Plan Nacional sobre Drogas
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Behavioral: Treatment as usualPatients in this arm received the usual treatment provided by the health system |
| Telematic intervention | Experimental | Behavioral: Internet/App interventionPatients in this arm received an App/internet-based psychotherapeutic intervention. |
| Standardized clinical intervention | Experimental | Behavioral: Standardized clinical interventionPatients in this arm received a standardized telephonic psychotherapeutic intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized clinical interventionThis 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. | Behavioural | Standardized clinical intervention |
| Internet/App interventionUsing 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. | Behavioural | Telematic intervention |
| Treatment as usualPatient will recieve the usual intervention provided by the Health system | Behavioural | Treatment as usual |
Primary outcome
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
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
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.
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.
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.
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.
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
7 secondary outcomes
Obstetric outcomes (Gestational week at birth)
Time frame: 12 months after enrollment
Obstetric outcomes (route of delivery)
Time frame: 12 months after enrollment
Obstetric outcomes (puerperal complications )
Time frame: 12 months after enrollment
Child Perinatal outcomes (Fetal birth weight)
Time frame: 12 months after enrollment
Child Perinatal outcomes (Apgar score)
Time frame: 12 months after enrollment
Child Perinatal outcomes (Arterial pH)
Time frame: 12 months after enrollment
Child Perinatal outcomes (resuscitation)
Time frame: 12 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Derived from this study: PubMed 42321702Carmona Camacho R, Lopez Carpintero N, Barrigon ML, Albarracin Garcia L, Barahona I, Baca-Garcia E, Ruiz Nogales C, Menendez I, Sanchez Alonso M, Vidal Marino C, Rodriguez Blanco L, Campos Soler SM, Diaz Rosell M, Le Cook B, Alegria M, Caro Canizares I. Evaluation of an e-health integrated intervention for pregnant women with co-occurring mental health and substance use symptoms: an exploratory randomized clinical trial. BMC Pregnancy Childbirth. 2026 Jun 20. doi: 10.1186/s12884-026-09436-z. Online ahead of print.
- Derived from this study: PubMed 42062994Lopez Carpintero N, Caro-Canizares I, Barrigon ML, Giraldez-Garcia C, Carmona Camacho R. Impact of the severity of maternal depression, anxiety, and post-traumatic stress disorder, as well as alcohol consumption, on perinatal outcomes. BMC Pregnancy Childbirth. 2026 Apr 30;26(1):511. doi: 10.1186/s12884-026-09179-x.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized clinical intervention, Internet/App intervention and Treatment as usual in people with Pregnancy and Mental Disorder, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression symptoms (time frame: 12 months after enrollment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06965270, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.