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Completed

NCT Number: NCT07165821

Effects of an Interpersonal Communication Skills Training Program on Medication Adherence of Schizophrenic Patients

This quasi-experimental two-group pretest-posttest study examined the effects of an interpersonal communication skills training program on medication adherence in patients with schizophrenia, measured at pre-intervention, post-intervention, and one-month follow-up.

Research Hypotheses

1. The experimental group receiving the interpersonal communication skills training program will show higher mean treatment adherence scores post-intervention and at one-month follow-up compared to baseline. 2. The experimental group will show higher mean treatment adherence scores post-intervention and at one-month follow-up than the control group receiving routine nursing care.

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Key information

Age range

20 year–59 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Prasrimahabhodi Psychiatric Hospital, ,Thailand

Nai Muang, Changwat Ubon Ratchathani, 34000, Thailand

About this study

Intervention : Interpersonal Communication Skills Training Program This program was developed based on DeVito's communication theory and integrated with the positive reinforcement-based interpersonal communication training developed by Thiengwiriyakul et al.(11) The program comprises six sessions: 1) Positive Communication 2) Equal Communication 3) Empathic Communication 4) Supportive Communication 5) Open Communication and 6) Relationship-Building Communication. The intervention was conducted three times per week, 60 minutes per session, over a two-week period.

Usual Care :

Usual care is defined as the provision of standard psychiatric nursing interventions consistent with usual clinical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male patients aged 20-59 with an ICD-10 schizophrenia diagnosis(F20.0-F20.9).
  • History of psychiatric readmission due to medication non-adherence
  • Mild psychiatric symptoms(Thai BPRS score ≤ 36).
  • Poor interpersonal communication skills(score ≤ 1.50 on Thiengviriya et al.'s assessment tool
  • Low to moderate medication adherence(score ≤ 42 on Uthaiphan & Daengdomyut's scale
  • Able to read, write, speak, and without hearing/visual impairments.
  • Had a primary caregiver post-discharge.
  • Provided informed consent voluntarily.

Exclusion criteria

Patients with other psychiatric comorbidities(e.g., depression, bipolar disorder, anxiety, or substance-induced psychosis)

Treatment and study plan

Interpersonal Communication Skills Training Program

Behavioral

This program was developed based on DeVito's communication theory and integrated with the positive reinforcement-based interpersonal communication training developed by Thiengwiriyakul et al.(11) This program was evaluated by a panel of three experts-a psychiatrist, a psychiatric nurse, and a psychiatric nursing academic-who assessed content relevance, appropriateness, and language clarity. After revisions based on their feedback, the program achieved a Content Validity Index (CVI) of 0.93, exceeding the acceptable threshold.

Usual Care

Behavioral

Received routine psychiatric nursing care

Primary outcomes

  1. Medication Adherence Behavior

    Time frame: Before the intervention, Immediately after the intervention , 1 month follow-up

    Treatment adherence refers to the extent to which patients with schizophrenia follow their prescribed medication regimen, assessed using the 16-item Treatment Adherence Behavior Assessment Scale (Uthaipan & Daengdomyut, 2013) It has been validated for content with a content validity index (CVI) of 0.88 and demonstrates good reliability with a Cronbach's alpha of 0.85. It consists of 16 items rated on a 4-point Likert scale (Always, Often, Occasionally, Never), divided into two parts: 1) Items 1-8: behaviors related to medication adherence. 2) Items 9-16: abilities to recognize and manage side effects. Seven items are negatively worded (Items 1, 2, 3, 7, 8, 12, 15), and nine items are positively worded (Items 4, 5, 6, 9, 10, 11, 13, 14, 16). The scoring is interpreted as follows: 1) ≤ 21 points: Low adherence 2) 21-42 points: Moderate adherence 3) ≥ 43 points: High adherence

Sponsors and collaborators

Lead sponsor

Suranaree University of Technology

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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