- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07165821
- Original Trial
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
- 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.
- 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Changwat Ubon Ratchathani
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Nai Muang, Changwat Ubon Ratchathani, Thailand, 34000
- Prasrimahabhodi Psychiatric Hospital, ,Thailand
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experiment group
The group of patients who received 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)
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.
|
|
Other: Control group
The group of patients who received routine psychiatric nursing care
|
Received routine psychiatric nursing care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Before the intervention, Immediately after the intervention , 1 month follow-up
|
Collaborators and Investigators
Investigators
- Study Chair: Arunee Roongrusamee, Dip.N.S., Prasrimahabhodi Psychiatric Hospital, Ubon Ratchathani, 34000, Thailand
- Principal Investigator: 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
Publications and helpful links
General Publications
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NursingSUT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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