Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2014 participants
INTERVENTIONAL
2016-07-31
2020-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment as usual
Patients in this arm received the usual treatment provided by the health system
Treatment as usual
Patient will recieve the usual intervention provided by the Health system
Telematic intervention
Patients in this arm received an App/internet-based psychotherapeutic intervention.
Internet/App intervention
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.
Standardized clinical intervention
Patients in this arm received a standardized telephonic psychotherapeutic intervention.
Standardized clinical intervention
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.
Interventions
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Standardized clinical intervention
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
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
Patient will recieve the usual intervention provided by the Health system
Eligibility Criteria
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Inclusion Criteria
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
2. Lacked capacity to consent, as determined by not being able to answer questions of the study purpose or process.
18 Years
FEMALE
No
Sponsors
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Plan Nacional sobre Drogas
UNKNOWN
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
OTHER
Responsible Party
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Other Identifiers
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2015I073
Identifier Type: -
Identifier Source: org_study_id
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