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

NCT05397925 | Completed

• 1 other identifier: 6649/CES/2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Substance Related Disorders

Keywords

Substance Related Disorder; Nursing Interventions; self management; training program; opiate substitution treatment

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Sections attendance rate

  Up to 21 weeks

• Nursing diagnoses status improvement

  Up to 21 weeks

Other Outcomes (4)

• Sex of paticipants

  Baseline

• Age of participants

  Baseline

• Type of the program

  Baseline

Study Arms (2)

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

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

Behavioral: Treatment as usual - Regular nursing consultation on a medication-based program

Interventions

ADSProgram - Self management for substance dependence program BEHAVIORAL

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.

ADSProgram

Treatment as usual - Regular nursing consultation on a medication-based program BEHAVIORAL

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.

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with impairment of thinking and perception
• Aggressive behaviour
• Psychomotor agitation.
• Patient with severe cognitive impairment (\<17 on Montreal Cognitive Assessment (MoCA))

Sponsors & Collaborators

• Nursing School of Lisbon: lead
• Center for Health Technology and Services Research: collaborator

Study Sites (2)

ETET Barreiro

Barreiro, Portugal

Location

Setubal Peninsula Integrated Response Center - THE REGIONAL HEALTH ADMINISTRATION OF LISBON AND VALE DO TEJO

Barreiro, Portugal

Location

Related Publications (6)

• 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.

  PMID: 30111209 BACKGROUND

• 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;

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 27200500 BACKGROUND

• 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.

  PMID: 31315862 BACKGROUND

• 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.

  PMID: 28359426 RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Paulo R Seabra

  Nursing School of Lisbon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Eligible participants will be recruited by the nurses of each institution. A baseline assessment will be carried out and the instruments will be applied after informed consent by participants. Participants will be randomly allocated to ADSProgram (experimental group). The control group will receive the treatment as usual (TAU). In both groups will be maintained the TAU. All participants will be re-assessed at the end of the program by assistant researchers. Principal Investigator will receive documental anonymized data.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 31, 2022
• Study Start: May 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)