NCT07165821

Brief Summary

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. 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

August 24, 2025

Last Update Submit

September 2, 2025

Conditions

Keywords

Medication AdherenceSchizophreniaInterpersonal Communication Skills Training

Outcome Measures

Primary Outcomes (1)

  • Medication Adherence Behavior

    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

    Before the intervention, Immediately after the intervention , 1 month follow-up

Study Arms (2)

Experiment group

EXPERIMENTAL

The group of patients who received Interpersonal Communication Skills Training Program

Behavioral: Interpersonal Communication Skills Training Program

Control group

OTHER

The group of patients who received routine psychiatric nursing care

Behavioral: Usual care

Interventions

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.

Experiment group
Usual careBEHAVIORAL

Received routine psychiatric nursing care

Control group

Eligibility Criteria

Age20 Years - 59 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prasrimahabhodi Psychiatric Hospital, ,Thailand

Nai Muang, Changwat Ubon Ratchathani, 34000, Thailand

Location

Related Publications (10)

  • He H, Liu Q, Li N, Guo L, Gao F, Bai L, Gao F, Lyu J. Trends in the incidence and DALYs of schizophrenia at the global, regional and national levels: results from the Global Burden of Disease Study 2017. Epidemiol Psychiatr Sci. 2020 Jan 13;29:e91. doi: 10.1017/S2045796019000891.

  • Charlson FJ, Ferrari AJ, Santomauro DF, Diminic S, Stockings E, Scott JG, McGrath JJ, Whiteford HA. Global Epidemiology and Burden of Schizophrenia: Findings From the Global Burden of Disease Study 2016. Schizophr Bull. 2018 Oct 17;44(6):1195-1203. doi: 10.1093/schbul/sby058.

  • Semahegn A, Torpey K, Manu A, Assefa N, Tesfaye G, Ankomah A. Psychotropic medication non-adherence and its associated factors among patients with major psychiatric disorders: a systematic review and meta-analysis. Syst Rev. 2020 Jan 16;9(1):17. doi: 10.1186/s13643-020-1274-3.

  • While A. Medication adherence: understanding the issues and finding solutions. Br J Community Nurs. 2020 Oct 2;25(10):474-479. doi: 10.12968/bjcn.2020.25.10.474.

  • Tan XH, Foo MA, Lim SLH, Lim MBXY, Chin AMC, Zhou J, Chiam M, Krishna LKR. Teaching and assessing communication skills in the postgraduate medical setting: a systematic scoping review. BMC Med Educ. 2021 Sep 9;21(1):483. doi: 10.1186/s12909-021-02892-5.

  • Riedl L, Nagels A, Sammer G, Straube B. A Multimodal Speech-Gesture Training Intervention for Patients With Schizophrenia and Its Neural Underpinnings - the Study Protocol of a Randomized Controlled Pilot Trial. Front Psychiatry. 2020 Mar 6;11:110. doi: 10.3389/fpsyt.2020.00110. eCollection 2020.

  • Combs DR, Adams SD, Penn DL, Roberts D, Tiegreen J, Stem P. Social Cognition and Interaction Training (SCIT) for inpatients with schizophrenia spectrum disorders: preliminary findings. Schizophr Res. 2007 Mar;91(1-3):112-6. doi: 10.1016/j.schres.2006.12.010. Epub 2007 Feb 12.

  • Park Y, Han K. Development and evaluation of a Communication Enhancement Program for People with Chronic Schizophrenia: A quasi-experimental pretest-posttest design study. Appl Nurs Res. 2018 Aug;42:1-8. doi: 10.1016/j.apnr.2018.04.007. Epub 2018 Apr 25.

  • Maassen E, Buttner M, Brocker AL, Stuke F, Bayer S, Hadzibegovic J, Just SA, Bertram G, Rau R, von Haebler D, Lempa G, Montag C. Measuring Emotional Awareness in Patients With Schizophrenia and Schizoaffective Disorders. Front Psychol. 2021 Nov 11;12:725787. doi: 10.3389/fpsyg.2021.725787. eCollection 2021.

  • Uzun G, Lok N. Effect of emotional awareness skills training on emotional awareness and communication skills in patients with schizophrenia: A Randomized Controlled Trial. Arch Psychiatr Nurs. 2022 Jun;38:14-20. doi: 10.1016/j.apnu.2022.01.005. Epub 2022 Jan 22.

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersMedication Adherence

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Arunee Roongrusamee, Dip.N.S.

    Prasrimahabhodi Psychiatric Hospital, Ubon Ratchathani, 34000, Thailand

    STUDY CHAIR
  • Palida Phalasak, M.N.S

    Prasrimahabhodi Psychiatric Hospital, Ubon Ratchathani, 34000, Thailand

    PRINCIPAL INVESTIGATOR
  • Aungkhana Chaiyarak, Dip.N.S.

    Prasrimahabhodi Psychiatric Hospital, Ubon Ratchathani, 34000, Thailand

    PRINCIPAL INVESTIGATOR
  • Sakda Khumkom, Ph.D.

    Institute of Nursing, Suranaree University of Technology, Nakhon Ratchasima, 30000, Thailand

    PRINCIPAL INVESTIGATOR
  • Thanakamon Leesri, Ph.D.

    Institute of Nursing, Suranaree University of Technology, Nakhon Ratchasima, 30000, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants who met the inclusion criteria were randomly assigned using a simple lottery method into an experimental group (n = 20) and a control group (n = 20).
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sakda Khumkom, Ph.D. , Asst.Prof., School of Psychiatric Nursing, Institue of Nursing, Suranaree University of Technology

Study Record Dates

First Submitted

August 24, 2025

First Posted

September 10, 2025

Study Start

June 1, 2024

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

IPD Sharing Statement: Individual participant data (IPD) will be made available following publication of the research article and will remain accessible for 10 years thereafter.

Shared Documents
STUDY PROTOCOL
Time Frame
10 years thereafter.
Access Criteria
Access instructions will be provided at that time

Locations