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NCT05397925: ADSProgram

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

Completed NA Last updated 19 September 2024
What this trial tests

NA trial testing ADSProgram - Self management for substance dependence program in Substance Related Disorders in 60 participants. Completed in 31 January 2024.

Timeline
1 May 2022
Primary endpoint
31 December 2023
31 January 2024

Quick facts

Lead sponsorNursing School of Lisbon
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposesupportive care
Enrollment60
Start date1 May 2022
Primary completion31 December 2023
Estimated completion31 January 2024
Sites2 locations across Portugal

Drugs / interventions tested

Conditions studied

Sponsor

Nursing School of Lisbon

Who can join

18 and older, any sex, with Substance Related Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing