Substance Related DisordersADSProgramNCT05397925
Effectiveness of a Training Program for Self-management of the Substance Addiction Consequences - a Study Protocol
A study testing ADSProgram - Self management for substance dependence program and Treatment as usual - Regular nursing consultation on a medication-based program in people with Substance Related Disorders, run by Nursing School of Lisbon at 2 sites in Portugal.
Trial summary
The substance dependent population has many health needs in which it is necessary to invest in competent approaches with more evidence. The main needs can be minimized when people are trained for self-care (abstinence, risk reduction and harm minimization) and for the necessary adaptations to the impact that these… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Related Disorders
- What is being tested?
- ADSProgram - Self management for substance dependence program and Treatment as usual - Regular nursing consultation on a medication-based program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPortugal
- Study dates
- 1 May 2022to 31 Jan 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years of age or older.
- Included in a medication-based program for at least 5 weeks in a specialized unit
- Accept to be followed in a nursing consultation.
- Severe severity (=<48 on Substance addiction Consequences (SAC) scale
Who cannot join
- Patients with impairment of thinking and perception
- Aggressive behaviour
- Psychomotor agitation.
- Patient with severe cognitive impairment (<17 on Montreal Cognitive Assessment (MoCA))
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
ETET Barreiro
Barreiro
Setubal Peninsula Integrated Response Center - THE REGIONAL HEALTH ADMINISTRATION OF LISBON AND VALE DO TEJO
Barreiro
About this study
Official title: Effectiveness of a Training Program for Self-management of the Substance Addiction Consequences - Protocol for a Randomized Controlled Trial
The substance dependent population has many health needs in which it is necessary to invest in competent approaches with more evidence. The main needs can be minimized when people are trained for self-care (abstinence, risk reduction and harm minimization) and for the necessary adaptations to the impact that these addictive behaviors and dependencies have on their lives and their families' lives.
Nursing can play a leading role in interventions aimed at reducing stigma and self-stigma, increasing users' knowledge for recovery, responding to the needs of older consumers, and helping training for self-management of substance dependence. However, about "nursing intervention programs" with people dependent on substances, the evidence is scarce. In many chronic illness situations, people need programs to train and develop a better capacity for self-management of their health situation.
Read more
Nurses in the Addictive Behaviors area globally closely linked to medication-based programs, hold consultations, manage programs and there is evidence of results that are sensitive to nursing care, however, professionals can and should seek new systematic approaches in response to people's needs and should seek to increase the level of evidence of the result of the interventions.
This complex phenomenon can be accompanied by the ability of individuals to manage the severity of the consequences. Based on all this, the following research question emerge: How effective could be an intervention program for training people to manage substance addiction consequences?
A randomized controlled trial that will be realized in one specialized unit on addictions, in Lisbon area. Pilot study will be carried out initially. The total sample will be constituted by individuals with substance use disorders, in a medication-based outpatient program, that will be receiving the ADSProgram (experimental group (n=30) and control group receiving treatment as usual (n=30). Both will be aplied for 21 weeks maximum.
The General Objective for this research is "To evaluate the effectiveness of a training program for self-management of the substance addiction consequences, with people integrated in medication-based programs".
The hypotheses to be tested is that this program is effective to reduce substance addiction consequences.
Read the detailed description
The substance dependent population has many health needs in which it is necessary to invest in competent approaches, with more evidence. The main needs can be minimized when people are trained for self-care (abstinence, risk reduction and harm minimization) and for the necessary adaptations to the impact that these addictive behaviors and dependencies have on their lives and their families' lives. It should be noted that people with addictive behavior, who have health needs, call for a more active role for nurses in their follow-up processes, value respect for care and value their co-decision on the care plan.
Nursing can play a leading role in interventions aimed to reduce stigma and self-stigma, increasing users' knowledge for recovery, responding to the needs of older consumers, and help to train for self-management of substance dependence. However, about "nursing intervention programs" with people dependent on substances, the evidence is scarce. In many chronic illness situations, people need programs to train and develop a better capacity for self-management of their health situation.
Nurses in the Addictive Behaviors area globally closely linked to medication-based programs, hold consultations, manage programs and there is evidence of results that are sensitive to nursing care, however, professionals can and should seek new systematic approaches in response to people's needs and should seek to increase the level of evidence of the outcomes of the interventions.
This complex phenomenon can be accompanied by the ability of individuals to manage the severity of the consequences, for which there are instruments to assess, and to improve "positive mental health" aimed to deepening persons state of health and changes that occur over time. Positive Mental Health can be defined as a value in itself (feeling good), a way of interpreting the environment in which participants find themselves to adapt and carry out changes that allow this adaptation. Mental health can be seen as an indicator of integration and adaptation and is often impaired by substance use.
Based on all this, the following research question emerge: How effective could be an intervention program for training people to manage substance addiction consequences?
The General Objective for this research is "To evaluate the effectiveness of a training program for self-management of the substance addiction consequences, with people integrated in medication-based programs".
The hypotheses to be tested is that this program is effective to reduce substance addiction consequences.
Based on these assumptions, investigators intend to carry out, a pilot (first) and a rondomized control study following the methodological recommendations for the development of complex interventions by the Medical Research Council - FEASIBILITY AND PILOTING - Testing, application and evaluation - Pilot study with the implementation of the training program for self-management of substance addiction consequences and ASSESSMENT (Randomized controlled experimental study).
A randomized controlled trial that will be realized in one specialized unit on addictions, in Lisbon area. Pilot study will be carried out initially with individuals with substance use disorders, in a medication-based outpatient program, that will be receiving the ADSProgram (experimental group (n=15) and control group receiving treatment as usual (n=15). In experimental group the ADSProgram will be applied for 21 weeks maximum for each patient. After pilot study research team intend to perform the RCT with experimental group (n=30) and control group (n=30) also.
From the day on which the selection of participants begins, participants will be randomly invited to participate in the study, starting with the first user evaluated in consultation after checking their criterion value on the substance addiction consequences scale (<=48). Some participants will be evaluated during the chronological course of the regular medication-based program, assisted in the nursing consultations and by the remaining professionals (control group). Others (with the same regular interventions) will be cumulatively invited to participate in the study, integrating the sample that will receive the interventions of the program (experimental group). Randomization will be done by previous determination of selected numbers by an online randomization application. Two sets of numbers will be created - the first set to control group and the second set to experimental group. Sample numbers will be created because when someone refuses to participate, nurses will select the next number in the randomized sets to different study arms. The enrollment will be strict since the first one in consultation and for those who accept to participate.
Also the sample will be theoretical randomized in face the homogenous comparative sample (sex, age groups, type of medication program and length on the program).
When completing the sample of 15 participants in the control group and 15 in the experimental group, the data will be analyzed comparing the effect between groups in reducing the substance addiction consequences. The size of the dropouts and their extension will also be analyzed in relation to the variables established for the homogeneity of the samples. After this evaluation of the results of the pilot study, the selection of participants will proceed until 30+30, with the initial sample being able to integrate the final study if the parallel sample remains with similar characteristics.
Descriptive, inferential, and multivariable statistical analyses will be used to describe participants, determine the effect size change and to determine which variables are related to better or worst severity. Missing data will be managed case by case due to the different variables under study.
- Conditions
- Substance Related Disorders
- Being tested
- ADSProgram - Self management for substance dependence program, Treatment as usual - Regular nursing consultation on a medication-based program
- Keywords
- Substance Related Disorder, Nursing Interventions, self management, training program, opiate substitution treatment
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADSProgram - Self management for substance dependence programBehavioural
GENERAL STRUCTURE OF THE MODEL - 8 sessions: One initial - assessment; 1 to 6 Intermediates - empowerment (Flexible number of intermediate sessions according to the person's need and accessibility, interlude 1 week minimum, up to a maximum of 3 weeks); 1 Final - autonomy; Duration of sessions: 20-60 min; Context: Outpatient specialized addictions unit. Private room needed; Preferred approach: Individual, face-to-face or virtual consultation. Complementary approach: In groups of up to 4 people, when peer support or sharing feelings are needed: Clinical focus 1 - Concerning the problematic use of substances, 2 - Related to health knowledge in general, 3 - Related to health-seeking behavior and adherence, 4 - Related to self-knowledge and well-being, 5 - Related to social role and personal dignity, 6 - Related to the family process.
Treatment as usual - Regular nursing consultation on a medication-based programBehavioural
Regular individual assessment on: substance used (kind of substance, consumption way, frequency), way of living, social relationship, health status nursing diagnoses. To support on this, therapeutic interventions, medication delivery and management support.
| Study group | Role | What they receive |
|---|---|---|
| ADSProgram | Experimental | This is the experimental arm of the study. This includes receiving the novel/experimental ADSProgram. Therapy description withheld to protect the integrity of the study.
Intervention: ADSprogram Receives: Behavioral: ADSProgram - Self management for substance dependence program |
| Treatment as usual | Active comparator | This is the control arm of the study. This includes receiving the standard of care on nursing Consultations on a medication-based program and multidisciplinary regular care. Therapy description withheld to protect the integrity of the study.
Intervention: Nursing Consultation Receives: Behavioral: Treatment as usual - Regular nursing consultation on a medication-based program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance Addiction Consequences Scale
It has 16 items, with a 5-point Likert scale (1-5), between severe and none, the higher the value, the lower the severity. The possible response range is between 16 and 80, with the value 48 referring to 50% of the possible range. Made up of four dimensions (psychological and family factors, physical and cognitive factors, economic and labor factors and self-care factors). The average of each item can be obtained in the range 1-5, with the midpoint 2.5. In each dimension, investigators calculate the average adjusted to the number of items.
Measured: Up to 21 weeks
Positive Mental Health Questionary
The questionnaire contains a series of statements about the way of thinking, feeling and acting, presenting 39 questions grouped into six dimensions (personal satisfaction; prosocial attitude; self-control; autonomy; problem-solving ability and personal fulfillment; interpersonal relationship skills). Is rated on a Likert scale from 1 to 4 points, with the following response possibilities: always or almost always (1 point), most of the time (2 points), sometimes (3 points) ), rarely or never (4 points). Higher the value, better the Positive Mental Health (PMH).
Measured: Up to 21 weeks
Secondary outcomes (2)
Sections attendance rate
(Number of attendance/Number of programed sections) x 100
Measured: Up to 21 weeks
Nursing diagnoses status improvement
(Number of participants who improve the status on half of diagnoses/Total sample who finalized the program) x 100
Measured: Up to 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 May 2022
- Primary completion31 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Substance Related DisordersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- ADSProgram - Program for self-management of Substance Dependence. It is a program based on a holistic view of the person and the ability to help people to reach their full potential based on their personal resources. It is also based on the need to focus interventions on the assessment and monitoring of substance addiction consequences. Is a harm reduction paradigm program to support self-management of this chronic condition. Aim: Training for self-management of substance addiction consequences; Promote adherence to the therapeutic project; Promote positive mental health. Therapeutic strategies - The principles of motivational interviewing, brief interventions with cognitive behavioral orientation and based on the assumptions of "helping relationship" to support the process of change.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nursing School of Lisbon
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Health Technology and Services Research
- Responsible party
- Principal investigator, Paulo Rosário Carvalho Seabra, Nursing School of Lisbon
- Investigators
- Paulo R Seabra, Principal investigator, Nursing School of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397925
- Sponsor's protocol ID
- 6649/CES/2020
- Acronym
- ADSProgram
- Status last verified
- Sep 2024
- First submitted
- 18 May 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seabra PRC, Amendoeira JJP, Sa LO, Capelas MLV. Clinical Validation of the Portuguese Version of "Substance Addiction Consequences" Derived from the Nursing Outcomes Classification. Issues Ment Health Nurs. 2018 Sep;39(9):779-785. doi: 10.1080/01612840.2018.1462870. Epub 2018 Aug 15.
PubMed 30111209Seabra PRC, Brantes ALG, Sequeira RMR, Sequeira ACOA, Simoes ASA, Nunes IDCBR, Amaral PE, Sequeira CAC. Acceptability and applicability of an intervention programme with substance addicts. Cien Saude Colet. 2023 Apr;28(4):1175-1186. doi: 10.1590/1413-81232023284.11732022. Epub 2022 Sep 30. English, Portuguese.
PubMed 37042898Sequeira C, Carvalho JC, Sampaio F, Sá L, Lluch-Canut T, Roldán-Merino J. Avaliação das propriedades psicométricas do Questionário de Saúde Mental Positiva em estudantes portugueses do ensino superior. Rev Port Enferm Saúde Ment. 2014;(11):45-53.
van Schie D, Castelein S, van der Bijl J, Meijburg R, Stringer B, van Meijel B. Systematic review of self-management in patients with schizophrenia: psychometric assessment of tools, levels of self-management and associated factors. J Adv Nurs. 2016 Nov;72(11):2598-2611. doi: 10.1111/jan.13023. Epub 2016 Jun 13.
PubMed 27200500Van de Velde D, De Zutter F, Satink T, Costa U, Janquart S, Senn D, De Vriendt P. Delineating the concept of self-management in chronic conditions: a concept analysis. BMJ Open. 2019 Jul 16;9(7):e027775. doi: 10.1136/bmjopen-2018-027775.
PubMed 31315862Sampaio FM, Sequeira C, Lluch Canut T. Content Validity of a Psychotherapeutic Intervention Model in Nursing: A Modified e-Delphi Study. Arch Psychiatr Nurs. 2017 Apr;31(2):147-156. doi: 10.1016/j.apnu.2016.09.007. Epub 2016 Sep 14.
PubMed 28359426
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Training Program for Self-management of the Substance Addiction Consequences - Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05397925
- Acronym / sponsor ID
- ADSProgram / 6649/CES/2020
- Conditions
- Substance Related Disorders
- Keywords
- Substance Related Disorder, Nursing Interventions, self management, training program, opiate substitution treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nursing School of LisbonUniversity, hospital or other
- Collaborators
- Center for Health Technology and Services Research
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 31 May 2022 (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 substance dependent population has many health needs in which it is necessary to invest in competent approaches with more evidence. The main needs can be minimized when people are trained for self-care (abstinence, risk reduction and harm minimization) and for the necessary adaptations to the impact that these addictive behaviors and dependencies have on their lives and their families' lives.
Nursing can play a leading role in interventions aimed at reducing stigma and self-stigma, increasing users' knowledge for recovery, responding to the needs of older consumers, and helping training for self-management of substance dependence. However, about "nursing intervention programs" with people dependent on substances, the evidence is scarce. In many chronic illness situations, people need programs to train and develop a better capacity for self-management of their health situation.
Nurses in the Addictive Behaviors area globally closely linked to medication-based programs, hold consultations, manage programs and there is evidence of results that are sensitive to nursing care, however, professionals can and should seek new systematic approaches in response to people's needs and should seek to increase the level of evidence of the result of the interventions.
This complex phenomenon can be accompanied by the ability of individuals to manage the severity of the consequences. Based on all this, the following research question emerge: How effective could be an intervention program for training people to manage substance addiction consequences?
A randomized controlled trial that will be realized in one specialized unit on addictions, in Lisbon area. Pilot study will be carried out initially. The total sample will be constituted by individuals with substance use disorders, in a medication-based outpatient program, that will be receiving the ADSProgram (experimental group (n=30) and control group receiving treatment as usual (n=30). Both will be aplied for 21 weeks maximum.
The General Objective for this research is "To evaluate the effectiveness of a training program for self-management of the substance addiction consequences, with people integrated in medication-based programs".
The hypotheses to be tested is that this program is effective to reduce substance addiction consequences.
Detailed description
The substance dependent population has many health needs in which it is necessary to invest in competent approaches, with more evidence. The main needs can be minimized when people are trained for self-care (abstinence, risk reduction and harm minimization) and for the necessary adaptations to the impact that these addictive behaviors and dependencies have on their lives and their families' lives. It should be noted that people with addictive behavior, who have health needs, call for a more active role for nurses in their follow-up processes, value respect for care and value their co-decision on the care plan.
Nursing can play a leading role in interventions aimed to reduce stigma and self-stigma, increasing users' knowledge for recovery, responding to the needs of older consumers, and help to train for self-management of substance dependence. However, about "nursing intervention programs" with people dependent on substances, the evidence is scarce. In many chronic illness situations, people need programs to train and develop a better capacity for self-management of their health situation.
Nurses in the Addictive Behaviors area globally closely linked to medication-based programs, hold consultations, manage programs and there is evidence of results that are sensitive to nursing care, however, professionals can and should seek new systematic approaches in response to people's needs and should seek to increase the level of evidence of the outcomes of the interventions.
This complex phenomenon can be accompanied by the ability of individuals to manage the severity of the consequences, for which there are instruments to assess, and to improve "positive mental health" aimed to deepening persons state of health and changes that occur over time. Positive Mental Health can be defined as a value in itself (feeling good), a way of interpreting the environment in which participants find themselves to adapt and carry out changes that allow this adaptation. Mental health can be seen as an indicator of integration and adaptation and is often impaired by substance use.
Based on all this, the following research question emerge: How effective could be an intervention program for training people to manage substance addiction consequences?
The General Objective for this research is "To evaluate the effectiveness of a training program for self-management of the substance addiction consequences, with people integrated in medication-based programs".
The hypotheses to be tested is that this program is effective to reduce substance addiction consequences.
Based on these assumptions, investigators intend to carry out, a pilot (first) and a rondomized control study following the methodological recommendations for the development of complex interventions by the Medical Research Council - FEASIBILITY AND PILOTING - Testing, application and evaluation - Pilot study with the implementation of the training program for self-management of substance addiction consequences and ASSESSMENT (Randomized controlled experimental study).
A randomized controlled trial that will be realized in one specialized unit on addictions, in Lisbon area. Pilot study will be carried out initially with individuals with substance use disorders, in a medication-based outpatient program, that will be receiving the ADSProgram (experimental group (n=15) and control group receiving treatment as usual (n=15). In experimental group the ADSProgram will be applied for 21 weeks maximum for each patient. After pilot study research team intend to perform the RCT with experimental group (n=30) and control group (n=30) also.
From the day on which the selection of participants begins, participants will be randomly invited to participate in the study, starting with the first user evaluated in consultation after checking their criterion value on the substance addiction consequences scale (<=48). Some participants will be evaluated during the chronological course of the regular medication-based program, assisted in the nursing consultations and by the remaining professionals (control group). Others (with the same regular interventions) will be cumulatively invited to participate in the study, integrating the sample that will receive the interventions of the program (experimental group). Randomization will be done by previous determination of selected numbers by an online randomization application. Two sets of numbers will be created - the first set to control group and the second set to experimental group. Sample numbers will be created because when someone refuses to participate, nurses will select the next number in the randomized sets to different study arms. The enrollment will be strict since the first one in consultation and for those who accept to participate.
Also the sample will be theoretical randomized in face the homogenous comparative sample (sex, age groups, type of medication program and length on the program).
When completing the sample of 15 participants in the control group and 15 in the experimental group, the data will be analyzed comparing the effect between groups in reducing the substance addiction consequences. The size of the dropouts and their extension will also be analyzed in relation to the variables established for the homogeneity of the samples. After this evaluation of the results of the pilot study, the selection of participants will proceed until 30+30, with the initial sample being able to integrate the final study if the parallel sample remains with similar characteristics.
Descriptive, inferential, and multivariable statistical analyses will be used to describe participants, determine the effect size change and to determine which variables are related to better or worst severity. Missing data will be managed case by case due to the different variables under study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- ADSProgram - Program for self-management of Substance Dependence. It is a program based on a holistic view of the person and the ability to help people to reach their full potential based on their personal resources. It is also based on the need to focus interventions on the assessment and monitoring of substance addiction consequences. Is a harm reduction paradigm program to support self-management of this chronic condition. Aim: Training for self-management of substance addiction consequences; Promote adherence to the therapeutic project; Promote positive mental health. Therapeutic strategies - The principles of motivational interviewing, brief interventions with cognitive behavioral orientation and based on the assumptions of "helping relationship" to support the process of change.
| Arm | Type | Receives |
|---|---|---|
| ADSProgram | Experimental | Behavioral: ADSProgram - Self management for substance dependence programThis is the experimental arm of the study. This includes receiving the novel/experimental ADSProgram. Therapy description withheld to protect the integrity of the study. Intervention: ADSprogram |
| Treatment as usual | Active comparator | Behavioral: Treatment as usual - Regular nursing consultation on a medication-based programThis is the control arm of the study. This includes receiving the standard of care on nursing Consultations on a medication-based program and multidisciplinary regular care. Therapy description withheld to protect the integrity of the study. Intervention: Nursing Consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults 18 years of age or older.
- Included in a medication-based program for at least 5 weeks in a specialized unit
- Accept to be followed in a nursing consultation.
- Severe severity (=<48 on Substance addiction Consequences (SAC) scale
Key exclusion criteria (4 listed)
- Patients with impairment of thinking and perception
- Aggressive behaviour
- Psychomotor agitation.
- Patient with severe cognitive impairment (<17 on Montreal Cognitive Assessment (MoCA))
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 |
|---|---|---|
| ADSProgram - Self management for substance dependence programGENERAL STRUCTURE OF THE MODEL - 8 sessions: One initial - assessment; 1 to 6 Intermediates - empowerment (Flexible number of intermediate sessions according to the person's need and accessibility, interlude 1 week minimum, up to a maximum of 3 weeks); 1 Final - autonomy; Duration of sessions: 20-60 min; Context: Outpatient specialized addictions unit. Private room needed; Preferred approach: Individual, face-to-face or virtual consultation. Complementary approach: In groups of up to 4 people, when peer support or sharing feelings are needed: Clinical focus 1 - Concerning the problematic use of substances, 2 - Related to health knowledge in general, 3 - Related to health-seeking behavior and adherence, 4 - Related to self-knowledge and well-being, 5 - Related to social role and personal dignity, 6 - Related to the family process. | Behavioural | ADSProgram |
| Treatment as usual - Regular nursing consultation on a medication-based programRegular individual assessment on: substance used (kind of substance, consumption way, frequency), way of living, social relationship, health status nursing diagnoses. To support on this, therapeutic interventions, medication delivery and management support. | Behavioural | Treatment as usual |
Primary outcome
Substance Addiction Consequences Scale
Time frame: Up to 21 weeks
It has 16 items, with a 5-point Likert scale (1-5), between severe and none, the higher the value, the lower the severity. The possible response range is between 16 and 80, with the value 48 referring to 50% of the possible range. Made up of four dimensions (psychological and family factors, physical and cognitive factors, economic and labor factors and self-care factors). The average of each item can be obtained in the range 1-5, with the midpoint 2.5. In each dimension, investigators calculate the average adjusted to the number of items.
Positive Mental Health Questionary
Time frame: Up to 21 weeks
The questionnaire contains a series of statements about the way of thinking, feeling and acting, presenting 39 questions grouped into six dimensions (personal satisfaction; prosocial attitude; self-control; autonomy; problem-solving ability and personal fulfillment; interpersonal relationship skills). Is rated on a Likert scale from 1 to 4 points, with the following response possibilities: always or almost always (1 point), most of the time (2 points), sometimes (3 points) ), rarely or never (4 points). Higher the value, better the Positive Mental Health (PMH).
2 secondary outcomes
Sections attendance rate
Time frame: Up to 21 weeks
Nursing diagnoses status improvement
Time frame: Up to 21 weeks
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 19 Sep 2024.
- Background: PubMed 30111209Seabra PRC, Amendoeira JJP, Sa LO, Capelas MLV. Clinical Validation of the Portuguese Version of "Substance Addiction Consequences" Derived from the Nursing Outcomes Classification. Issues Ment Health Nurs. 2018 Sep;39(9):779-785. doi: 10.1080/01612840.2018.1462870. Epub 2018 Aug 15.
- Background: PubMed 37042898Seabra PRC, Brantes ALG, Sequeira RMR, Sequeira ACOA, Simoes ASA, Nunes IDCBR, Amaral PE, Sequeira CAC. Acceptability and applicability of an intervention programme with substance addicts. Cien Saude Colet. 2023 Apr;28(4):1175-1186. doi: 10.1590/1413-81232023284.11732022. Epub 2022 Sep 30. English, Portuguese.
- BackgroundSequeira C, Carvalho JC, Sampaio F, Sá L, Lluch-Canut T, Roldán-Merino J. Avaliação das propriedades psicométricas do Questionário de Saúde Mental Positiva em estudantes portugueses do ensino superior. Rev Port Enferm Saúde Ment. 2014;(11):45-53.
- Background: PubMed 27200500van Schie D, Castelein S, van der Bijl J, Meijburg R, Stringer B, van Meijel B. Systematic review of self-management in patients with schizophrenia: psychometric assessment of tools, levels of self-management and associated factors. J Adv Nurs. 2016 Nov;72(11):2598-2611. doi: 10.1111/jan.13023. Epub 2016 Jun 13.
- Background: PubMed 31315862Van de Velde D, De Zutter F, Satink T, Costa U, Janquart S, Senn D, De Vriendt P. Delineating the concept of self-management in chronic conditions: a concept analysis. BMJ Open. 2019 Jul 16;9(7):e027775. doi: 10.1136/bmjopen-2018-027775.
- Results publication: PubMed 28359426Sampaio FM, Sequeira C, Lluch Canut T. Content Validity of a Psychotherapeutic Intervention Model in Nursing: A Modified e-Delphi Study. Arch Psychiatr Nurs. 2017 Apr;31(2):147-156. doi: 10.1016/j.apnu.2016.09.007. Epub 2016 Sep 14.
- Individual participant dataSharing planned: No
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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.
Paulo R Seabra principal investigator
Nursing School of Lisbon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADSProgram - Self management for substance dependence program and Treatment as usual - Regular nursing consultation on a medication-based program in people with Substance Related Disorders, run by Nursing School of Lisbon at 2 sites in Portugal.
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 4 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Substance Addiction Consequences Scale (time frame: Up to 21 weeks). The study lists 2 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 NCT05397925, which also lists 6 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 19 Sep 2024.