Schizophrenia; PsychosisNCT07165821
Effects of an Interpersonal Communication Skills Training Program on Medication Adherence of Schizophrenic Patients
A study testing Interpersonal Communication Skills Training Program in people with Schizophrenia; Psychosis and Remission, run by Suranaree University of Technology at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 59 years, men only
- Conditions the study is for
- Schizophrenia; Psychosis, Remission, Non-Adherence, Medication
- What is being tested?
- Interpersonal Communication Skills Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients with other psychiatric comorbidities(e.g., depression, bipolar disorder, anxiety, or substance-induced psychosis)
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Prasrimahabhodi Psychiatric Hospital, ,Thailand
Nai Muang, Changwat Ubon Ratchathani, 34000
About this study
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.
Read the 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.
- Being tested
- Interpersonal Communication Skills Training Program, Usual care
- Keywords
- Medication Adherence, Schizophrenia, Interpersonal Communication Skills Training
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Communication Skills Training ProgramBehavioural
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 careBehavioural
Received routine psychiatric nursing care
| Study group | Role | What they receive |
|---|---|---|
| Experiment group | Experimental | The group of patients who received Interpersonal Communication Skills Training Program Receives: Behavioral: Interpersonal Communication Skills Training Program |
| Control group | Other | The group of patients who received routine psychiatric nursing care Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before the intervention, Immediately after the intervention , 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Jun 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia; PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suranaree University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sakda Khumkom, Suranaree University of Technology
- Investigators
- Arunee Roongrusamee, Dip.N.S., Study chair, Prasrimahabhodi Psychiatric Hospital, Ubon Ratchathani, 34000, ThailandPalida Phalasak, M.N.S, Principal investigator, Prasrimahabhodi Psychiatric Hospital, Ubon Ratchathani, 34000, ThailandAungkhana Chaiyarak, Dip.N.S., Principal investigator, Prasrimahabhodi Psychiatric Hospital, Ubon Ratchathani, 34000, ThailandSakda Khumkom, Ph.D., Principal investigator, Institute of Nursing, Suranaree University of Technology, Nakhon Ratchasima, 30000, ThailandThanakamon Leesri, Ph.D., Principal investigator, Institute of Nursing, Suranaree University of Technology, Nakhon Ratchasima, 30000, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165821
- Sponsor's protocol ID
- NursingSUT
- Status last verified
- Sep 2025
- First submitted
- 24 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 31928566Charlson 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.
PubMed 29762765Semahegn 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.
PubMed 31948489While 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.
PubMed 33030359Tan 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.
PubMed 34503497Riedl 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.
PubMed 32210849Combs 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.
PubMed 17293083Park 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.
PubMed 30029708Maassen 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.
PubMed 34858263Uzun 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.
PubMed 35461642
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Interpersonal Communication Skills Training Program on Medication Adherence of Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT07165821
- Acronym / sponsor ID
- NursingSUT
- Keywords
- Medication Adherence, Schizophrenia, Interpersonal Communication Skills Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Suranaree University of TechnologyUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment group | Experimental | Behavioral: Interpersonal Communication Skills Training ProgramThe group of patients who received Interpersonal Communication Skills Training Program |
| Control group | Other | Behavioral: Usual careThe group of patients who received routine psychiatric nursing care |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with other psychiatric comorbidities(e.g., depression, bipolar disorder, anxiety, or substance-induced psychosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpersonal Communication Skills Training ProgramThis 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. | Behavioural | Experiment group |
| Usual careReceived routine psychiatric nursing care | Behavioural | Control group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Results publication: PubMed 31928566He 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.
- Results publication: PubMed 29762765Charlson 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.
- Results publication: PubMed 31948489Semahegn 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.
- Results publication: PubMed 33030359While 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.
- Results publication: PubMed 34503497Tan 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.
- Results publication: PubMed 32210849Riedl 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.
- Results publication: PubMed 17293083Combs 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.
- Results publication: PubMed 30029708Park 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.
- Results publication: PubMed 34858263Maassen 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.
- Results publication: PubMed 35461642Uzun 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.
- fact- sheets of schizophrenia from WHOLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arunee Roongrusamee, Dip.N.S. study chair
Prasrimahabhodi Psychiatric Hospital, Ubon Ratchathani, 34000, Thailand
Palida Phalasak, M.N.S principal investigator
Prasrimahabhodi Psychiatric Hospital, Ubon Ratchathani, 34000, Thailand
Aungkhana Chaiyarak, Dip.N.S. principal investigator
Prasrimahabhodi Psychiatric Hospital, Ubon Ratchathani, 34000, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Communication Skills Training Program in people with Schizophrenia; Psychosis and Remission, run by Suranaree University of Technology at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence Behavior (time frame: Before the intervention, Immediately after the intervention , 1 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07165821, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.