Effectiveness of a Training Program for Self-management of the Substance Addiction Consequences - a Study Protocol

Substance Related Disorders Clinical Trial

— ADSProgram  

Official title:

Effectiveness of a Training Program for Self-management of the Substance Addiction Consequences - Protocol for a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05397925
• Other study ID #: 6649/CES/2020
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: February 15, 2023

Study information

• Verified date: May 2022
• Source: Nursing School of Lisbon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: February 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients with impairment of thinking and perception

• Aggressive behaviour

• Psychomotor agitation.

• Patient with severe cognitive impairment (<17 on Montreal Cognitive Assessment (MoCA))

Related Conditions & MeSH terms

• Substance Related Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• ADSProgram - Self management for substance dependence program
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 program
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.

Locations

Country	Name	City	State
Portugal	Setubal Peninsula Integrated Response Center - THE REGIONAL HEALTH ADMINISTRATION OF LISBON AND VALE DO TEJO	Barreiro

Sponsors (2)

Lead Sponsor	Collaborator
Nursing School of Lisbon	Center for Health Technology and Services Research

Country where clinical trial is conducted

Portugal, 

References & Publications (6)

Sampaio 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. — View Citation

Seabra P, Amendoeira J, Sá L, Capelas M. Clinical Validation of the Portuguese Version of "Substance Addiction Consequences" Derived from the Nursing Outcomes Classification. Issues Ment Health Nurs [Internet]. 2018;39(8):779-85. Available from: https://doi.org/10.1080/01612840.2018.1462870

Seabra P, Brantes AL, Sequeira R, Sequeira A, Nunes I, Sequeira C. Aceitabilidade e aplicabilidade de um programa de intervenção com usuários dependentes de substâncias. Submitted. 2021;

Sequeira 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 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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sex of paticipants	sex	Baseline
Other	Age of participants	Age group	Baseline
Other	Type of the program	Type of medication program	Baseline
Other	Lengh of medication program	lengh on the program	Baseline
Primary	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.	Up to 21 weeks
Primary	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).	Up to 21 weeks
Secondary	Sections attendance rate	(Number of attendance/Number of programed sections) x 100	Up to 21 weeks
Secondary	Nursing diagnoses status improvement	(Number of participants who improve the status on half of diagnoses/Total sample who finalized the program) x 100	Up to 21 weeks