Effectiveness of a Training Program for Self-management of the Substance Addiction Consequences - Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Positive Mental Health Questionary
研究概览
简要总结
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.
详细描述
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients with impairment of thinking and perception
- •Aggressive behaviour
- •Psychomotor agitation.
- •Patient with severe cognitive impairment (<17 on Montreal Cognitive Assessment (MoCA))
研究组 & 干预措施
ADSProgram
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
干预措施: ADSProgram - Self management for substance dependence program (Behavioral)
Treatment as usual
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
干预措施: Treatment as usual - Regular nursing consultation on a medication-based program (Behavioral)
结局指标
主要结局
Positive Mental Health Questionary
时间窗: 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).
Substance Addiction Consequences Scale
时间窗: 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.
次要结局
- Nursing diagnoses status improvement(Up to 21 weeks)
- Sections attendance rate(Up to 21 weeks)
研究者
Paulo Rosário Carvalho Seabra
Prof.
Nursing School of Lisbon