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临床试验/NCT07080827
NCT07080827进行中(未招募)不适用

The Effect of Transtheoretical Model-Based Psychoeducation Via Social Media on Treatment Adherence in Individuals Diagnosed With Psychosis

Istanbul University - Cerrahpasa2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
2
主要终点
Medication Adherence (Treatment adherence)

研究概览

简要总结

This doctoral research investigates the effect of a Transtheoretical Model (TTM)-based psychoeducation program delivered via social media on treatment adherence in individuals diagnosed with psychosis. The study follows a randomized controlled trial design with pretest, posttest, and three-month follow-up assessments.

A total of 60 participants were selected from among 354 individuals registered at the Balıkesir Community Mental Health Center (CMHC), based on predefined inclusion and exclusion criteria. Participants were randomly assigned into three groups:

  1. an online intervention group receiving a 5-week TTM-based treatment adherence psychoeducation program via WhatsApp;
  2. a face-to-face intervention group receiving a standard, non-TTM-based treatment adherence psychoeducation program over 3 weeks at the CMHC; and
  3. a control group that received no educational intervention, only assessments.

Data collection instruments include a Sociodemographic Information Form, the Stage of Change Identification Form, the Medication Adherence Report Scale (MARS-5), and the Clinical Global Impression-Severity Scale (CGI-S). Measurements were conducted at baseline, post-intervention, and three months after the intervention.

The study hypotheses are:

Research Hypotheses H1: The treatment adherence scale scores of individuals diagnosed with psychosis who participate in the TTM-based psychoeducation group administered via social media will differ compared to the scores of individuals who participate in the face-to-face treatment adherence psychoeducation group.

H2: The treatment adherence scale scores of individuals diagnosed with psychosis who participate in the TTM-based psychoeducation group administered via social media will differ compared to the scores of individuals who do not receive TTM-based psychoeducation.

This study aims to provide evidence for the efficacy of theory-based, technology-supported psychoeducation programs in enhancing treatment adherence among individuals with psychosis. Furthermore, it evaluates whether a model-based online psychoeducation program is more effective than a conventional treatment adherence education.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 65 years
  • Diagnosed with a psychotic disorder according to DSM-5 criteria, including:
  • Schizophrenia
  • Schizophreniform disorder
  • Schizoaffective disorder (with mild mood symptoms)
  • Brief psychotic disorder
  • Substance/medication-induced psychotic disorder (in remission)
  • Paranoid disorder
  • On the same prescribed psychiatric medication for at least one month
  • Able to communicate in Turkish
  • Has access to the internet and owns at least one active social media account (Instagram, Twitter, Facebook, WhatsApp, etc.)
  • Literate and able to complete self-report forms
  • Willing to participate and provide informed consent
  • Clinical Global Impression-Severity (CGI-S) score of 4 or below

排除标准

  • Under 18 or over 65 years of age
  • Acute psychotic episode at the time of recruitment
  • Comorbid psychiatric diagnoses not covered under the inclusion list
  • Diagnosed with neurocognitive disorders (e.g., dementia)
  • Diagnosed with intellectual disability (mental retardation)
  • Unable to use smartphone, tablet, or other digital communication tools
  • Missed more than 20% of the intervention sessions

结局指标

主要结局

Medication Adherence (Treatment adherence)

时间窗: Baseline (Week 0) and Post-Intervention (Week 5)

Score on a 5-point Likert scale

Change in Medication Adherence Scores (MARS-5)

时间窗: Baseline, Post-Intervention (Week 5), and 3-Month Follow-Up

Medication adherence will be assessed using the 5-item Medication Adherence Report Scale (MARS-5), originally developed by Horne and Hankins (2001). It is a generic, self-reported Likert-type scale validated across various chronic physical and psychiatric conditions, including bipolar disorder, hypertension, asthma, and schizophrenia. Each item is rated on a 5-point scale from 1 (always) to 5 (never), yielding a total score between 5 and 25. Higher scores indicate better adherence. The Turkish version of the scale was adapted by the investigators and demonstrated acceptable internal consistency (Cronbach's α = 0.78). Factor analyses supported a unidimensional structure (KMO = 0.79; CFI = 0.97; RMSEA = 0.089), consistent with the original. In this study, MARS-5 will be administered at three time points: prior to the intervention (baseline), immediately following the intervention (post-test), and three months after the intervention (follow-up) to assess changes in treatment adherence

次要结局

未报告次要终点

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ibrahim Aldemir, PhD

Doctoral Researcher

Istanbul University - Cerrahpasa

研究点 (2)

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