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

NCT05397925 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Center for Health Technology and Services Research

    collaborator OTHER
  • Nursing School of Lisbon

    lead OTHER

Principal Investigators

  • Paulo R Seabra · Nursing School of Lisbon

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2023-12-31
Completion
2024-01-31

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05397925 on ClinicalTrials.gov