NCT07080827

Brief Summary

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. 1.an online intervention group receiving a 5-week TTM-based treatment adherence psychoeducation program via WhatsApp;
  2. 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. 3.a control group that received no educational intervention, only assessments.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

July 11, 2025

Last Update Submit

July 20, 2025

Conditions

Keywords

Treatment Compliance and ComplianceMental Health NursingOnline Psychoeducation

Outcome Measures

Primary Outcomes (2)

  • Medication Adherence (Treatment adherence)

    Score on a 5-point Likert scale

    Baseline (Week 0) and Post-Intervention (Week 5)

  • Change in Medication Adherence Scores (MARS-5)

    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

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

Study Arms (3)

Online TTM-Based Psychoeducation

EXPERIMENTAL
Behavioral: TTM-Based Online Psychoeducation Program

Face-to-Face Standard Psychoeducation

ACTIVE COMPARATOR
Behavioral: Standard Face-to-Face Psychoeducation Program

Delayed Online Psychoeducation Group

ACTIVE COMPARATOR
Other: TTM-Based Online Psychoeducation Program

Interventions

A 3-week conventional psychoeducation program delivered face-to-face at the Community Mental Health Center. The program focused on general treatment adherence without utilizing the Transtheoretical Model and included verbal education, printed materials, and discussions.

Face-to-Face Standard Psychoeducation

A 5-week structured psychoeducation program based on the Transtheoretical Model (TTM), delivered via WhatsApp. Educational content was tailored to the participant's stage of change and included videos, texts, and interactive materials to promote treatment adherence in individuals with psychosis.

Online TTM-Based Psychoeducation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Under 18 or over 65 years of age
  • Acute psychotic episode at the time of recruitment
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balıkesir Provincial Health Directorate, Community Mental Health Center

Balıkesir, Balıkesir, 10050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient CompliancePsychotic Disorders

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Researcher

Study Record Dates

First Submitted

July 11, 2025

First Posted

July 23, 2025

Study Start

March 1, 2025

Primary Completion

April 1, 2025

Study Completion

November 30, 2025

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations