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临床试验/NCT06022497
NCT06022497已完成不适用

The Effect of Tidal Model-Based Emotion Regulation Nursing Interventions on Recovery in Individuals Diagnosed With Nursing Diagnosis of Impaired Mood Regulation

Izmir Katip Celebi University2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
2
主要终点
Difficulties in Emotion Regulation

研究概览

简要总结

The aim of this study is to investigate the effectiveness of Tidal Model-based emotion regulation interventions on recovery in individuals diagnosed with depression and nursing diagnosis of impaired mood regulation. The research was designed as a randomized controlled trial.

The main hypothesis; After nursing interventions for emotion regulation based on the Tidal Model, there is a significant difference between the recovery, difficulty in emotion regulation, depression levels and nursing outcome criteria of individuals in the intervention and control groups.

详细描述

The research carried out with patients followed in psychiatry outpatient clinics. As a result of the G-power analysis, the sample consisted of 23 interventions and 23 control groups. In the study, while the control group received only routine treatment, in the intervention group, Tidal Model-based nursing interventions were applied in addition to the routine treatment. Pre-tests administered before individuals were randomly assigned to the intervention and control groups. Randomization was created using the website randomizer.org. After this randomization was created, it was hidden from the physician who made the diagnosis of depression and from the researcher who conducted the interviews (allocation concealment). After the pre-tests were completed, the researcher (consulting faculty member) who knew the random assignment order was reached and the individuals were randomly assigned to the control or intervention group. Tidal Model-based nursing interventions were structured as 8 sessions in total. Each individual in the intervention group participated in a session for a total of 8 weeks, one session per week. In the eighth session, post-tests were applied to the individuals in the intervention group. Individuals in the control group were asked to come back 8 weeks after the first interviews and post-tests were applied. All interviews were conducted face to face. Recovery Assessment Scale (RAS), Difficulties in Emotion Regulation Scale (DERS), and Nursing Outcomes Criteria (NOC) were used.

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
None

入排标准

年龄范围
25 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of moderate Depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria
  • •Having a nursing diagnosis of Impaired Mood Regulation
  • •Psychiatrist prescribing serotonin reuptake inhibitor (SSRI)
  • •Man or Women aged 25-55
  • •Being followed by the psychiatry outpatient clinic
  • •Able to provide written informed consent

排除标准

  • •Presence of an additional mental illness
  • •Diagnosis of severe Depression according to DSM-V criteria
  • •Presence of suicidal attempts or thoughts
  • •Presence of another physical illness that affects cognition
  • •Have received any kind of therapy in the last six months
  • •Voluntary involvement in another study at the same time
  • •Inability to read and write

研究组 & 干预措施

Control Group

No Intervention

The control group received only routine treatment.

Intervention Group

Experimental

In the intervention group, Tidal Model-based emotion regulation nursing interventions were applied in addition to the routine treatment. Tidal Model-based emotion regulation nursing interventions were structured as eight sessions in total. Each individual in the intervention group participated in a session for a total of 8 weeks, one session per week. All interviews were conducted face to face.

干预措施: Tidal Model Based Emotion Regulation Interventions (Other)

结局指标

主要结局

Difficulties in Emotion Regulation

时间窗: before and end of the interventions (eight weeks)

Difficulties in Emotion Regulation was developed by Gratz and Roemer (2004), and adapted to Turkish by Rugancı and Gencoz (2010) who also carried out the validity and reliability. It consist of 36 items, 5 point likert type. A high score on the scale indicates difficulty in emotion regulation. Scale has six factors: Awareness, Clarity, Impulse, Goals, Non-acceptance, Strategies.

Hamilton Depression Rating Scale

时间窗: before and end of the interventions (eight weeks)

Hamilton Depression Rating Scale was developed Hamilton et al. (1960), and adapted to Turkish by Akdemir et al. (1997) who also carried out the validity and reliability. The highest 51 points can be obtained from the scale.A score of less than 7 indicates that there is no depression, 8 to 15 points of mild depression, 16-28 points of moderate level, and 29 points and above indicate severe depression.

Recovery Assesment Scale

时间窗: before and end of the interventions (eight weeks)

Recovery Assesment Scale was developed by Corrigan et al. (2004), and adapted to Turkish by Guler and Gurkan (2017) who also carried out the validity and reliability. It consist of 24 items, 5 point likert type. A high total score from the scale indicates a high level of improvement.Scale has five factors: personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and no domination by symptoms

次要结局

  • Nursing Outcome Criteria(before and end of the interventions (eight weeks))

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gulsenay TAS SOYLU

Principal Investigator

Izmir Katip Celebi University

研究点 (2)

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