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| Name | Class |
|---|---|
| Plan Nacional sobre Drogas | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as usual | Active Comparator | Patients in this arm received the usual treatment provided by the health system |
|
| Telematic intervention | Experimental | Patients in this arm received an App/internet-based psychotherapeutic intervention. |
|
| Standardized clinical intervention | Experimental | Patients in this arm received a standardized telephonic psychotherapeutic intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Obstetric outcomes (Gestational week at birth) | After birth, we measured the gestational week at the time of birth (number of weeks) | 12 months after enrollment |
| Obstetric outcomes (route of delivery) |
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Inclusion criteria:
Exclusion criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42321702 | Derived | 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. | |
| 42062994 |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
| D000092862 | Psychological Well-Being |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| 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 |
|
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 |
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.
| 12 months after enrollment |
| Obstetric outcomes (puerperal complications ) | After birth, we evaluated the presence of puerperal complications (Yes/no) | 12 months after enrollment |
| Child Perinatal outcomes (Fetal birth weight) | After birth, we measured fetal birth weight (gr) | 12 months after enrollment |
| Child Perinatal outcomes (Apgar score) | After birth, we measured Apgar score, assessed at one and five minutes. | 12 months after enrollment |
| Child Perinatal outcomes (Arterial pH) | After birth, we measured Arterial pH | 12 months after enrollment |
| Child Perinatal outcomes (resuscitation) | After birth, we measured the Need (Yes/no) and type of resuscitation (0-V) | 12 months after enrollment |
| Derived |
| Lopez 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. |