Motivational InterviewingNCT04022577
Effects of Adherence Therapy on Medication Adherence in Patients With Schizophrenia Spectrum Disorder
A study testing Adherence Therapy in people with Motivational Interviewing and Schizophrenia Spectrum Disorder, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
This study will explore the effect of Adherence Therapy(AT) on medication adherence in patients with schizophrenia spectrum disorder. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Motivational Interviewing, Schizophrenia Spectrum Disorder, Medication Adherence
- What is being tested?
- Adherence Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2018to 30 Sep 2019
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 20-64
- were Chinese speaking or Taiwanese speaking;
- diagnosed with schizophrenia or schizoaffective disorder
- recent history of non-adherence to antipsychotic medication.
- Non-adherence to medication was defined as a recent history of cessation of psychiatric admission for more than one month at a time
- The patient recently (half year) relapse of mental illness
- Family and Health care worker state that the patient has taken irregular medication
- demonstrated cognitive understanding of the research plan and provided consent.
Who cannot join
- discharged from hospital for at least 3 months
- no intellectual disability, organic brain diseases or Cognitive impairment
- no alcohol or sub-stance abuse problems
- were not attending medication management program .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Adherence Therapy on Medication Adherence in Patients With Schizophrenia Spectrum Disorder: A Randomized Controlled Trial
This study will explore the effect of Adherence Therapy(AT) on medication adherence in patients with schizophrenia spectrum disorder.
Read the detailed description
A single-blind, randomized controlled trial with a repeated-measures, two parallel groups design will be conducted for 120 participants with schizophrenia spectrum in regional hospital in northern Taiwan. After baseline data collection finished, the blocked randomization will be employed to assign participants to two groups. The experimental group will participate in a eight session course of Adherence Therapy. The control group received routine care. The data will be collected for baseline(T0) and after 4 session interim analysis(T1；9-12 weeks) and 8 session after intervention(T2；21-28 weeks). A structured Questionnaire will use to collect data on the Medication Adherence Rating Scale, Schedule for the Assessment of Insight, Internalized Stigma of Mental Illness Scale, Self-Appraisal of Illness Questionnaire and Positive and Negative Syndrome Scale. Data analysis will employ Statistical Package for the Social Sciences 20.0 with Generalized estimating equations approach to examine effects of Adherence Therapy and routine care on medication adherence.
- Being tested
- Adherence Therapy, control group
- Keywords
- Adherence Therapy, Insight, Medication Adherence, Motivational Interviewing, Schizophrenia Spectrum Disorder, Symptom severity, Randomized controlled trial
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence TherapyBehavioural
Also called Motivational interviewing
Motivational interviewing-based AT in this study was based on Chien et al., (2016) and Gray et al., (2010) eight-session AT using the motivational interviewing technique (and principles of cognitive behavioral therapy).
control groupBehavioural
The control group received routine care
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The experimental group will participate in a eight session course of Adherence Therapy Receives: Behavioral: Adherence Therapy |
| control group | Placebo comparator | The control group received routine care Receives: Behavioral: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence Rating Scale
The Medication Adherence Rating Scale was developed by Thompson et al. (2000). It evaluates the adherence behavior and attitude of the patient within the previous week. There are 10 close-ended questions (yes/no answers) in the questionnaire.
Measured: for two study groups at baseline(T0) and after 4 session interim analysis (T1；9-12 weeks) and 8 session after intervention (T2；21-28 weeks).
Secondary outcomes (3)
Schedule for the Assessment of Insight, SAI
The Schedule of Assessment of Insight (SAI) measures multiple dimensions of insight, including compliance with treatment, recognition of illness, re-labeling of psychotic phenomena, and awareness of changes in mental functioning and psychosocial consequences of the illness.The maximum score of the SAI is 14, with higher SAI scores indicating greater insight. The Cronbach alpha for the SAI was 0.96, and inter-rater reliability (r) between the two research psychiatrists was .92 in the present study.
Measured: for two study groups at baseline(T0) and after 4 session interim analysis(T1；9-12 weeks) and 8 session after intervention(T2；21-28 weeks).
Positive and Negative Syndrome Scale, PANSS
PANSS assessed the severity of psychotic symptoms in terms of three subscales, including positive symptoms (hallucinations,delusional beliefs, and 30-item 7point Likert scale (from 1-'Absent' to 7-'Extremely').
Measured: for two study groups at baseline(T0) and after 4 session interim analysis(T1；9-12 weeks) and 8 session after intervention(T2；21-28 weeks).
Self-Appraisal of Illness Questionnaire, SAIQ
The Self-Appraisal of Illness Questionnaire (SAIQ) was used to assess patients' insight into their illness.The need for treatment and presence/outcome of illness subscales of SAIQ have been used as brief screening instruments for schizophrenic patients who may be at risk for treatment noncompliance. Lower SAIQ subscale scores indicate reduced awareness of the psychiatric illness. This scale is a self reporting instrument composed of 17 items in which participants are asked to rate the extent to which they agreed with each statement by using a 4-point Likert scale ranging from 0 (ie, "do not agree at all") to 3 (ie, "agree completely").
The internal consistency of the scale was 0.867, and the retest reliability was 0.82.
Measured: for two study groups at baseline(T0) and after 4 session interim analysis(T1；9-12 weeks) and 8 session after intervention(T2；21-28 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 Oct 2018
- Primary completion30 Aug 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motivational InterviewingStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Responsible party
- Sponsor
- Investigators
- Yan Laing Chen, BSN, Study chair, Institute of Community Health Care National Yang-Ming University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022577
- Sponsor's protocol ID
- YM108024E
- Status last verified
- Oct 2023
- First submitted
- 10 Jul 2019
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adherence Therapy on Medication Adherence in Patients With Schizophrenia Spectrum Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04022577
- Acronym / sponsor ID
- YM108024E
- Keywords
- Adherence Therapy, Insight, Medication Adherence, Motivational Interviewing, Schizophrenia Spectrum Disorder, Symptom severity, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 17 Jul 2019 (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 study will explore the effect of Adherence Therapy(AT) on medication adherence in patients with schizophrenia spectrum disorder.
Detailed description
A single-blind, randomized controlled trial with a repeated-measures, two parallel groups design will be conducted for 120 participants with schizophrenia spectrum in regional hospital in northern Taiwan. After baseline data collection finished, the blocked randomization will be employed to assign participants to two groups. The experimental group will participate in a eight session course of Adherence Therapy. The control group received routine care. The data will be collected for baseline(T0) and after 4 session interim analysis(T1；9-12 weeks) and 8 session after intervention(T2；21-28 weeks). A structured Questionnaire will use to collect data on the Medication Adherence Rating Scale, Schedule for the Assessment of Insight, Internalized Stigma of Mental Illness Scale, Self-Appraisal of Illness Questionnaire and Positive and Negative Syndrome Scale. Data analysis will employ Statistical Package for the Social Sciences 20.0 with Generalized estimating equations approach to examine effects of Adherence Therapy and routine care on medication adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Adherence TherapyThe experimental group will participate in a eight session course of Adherence Therapy |
| control group | Placebo comparator | Behavioral: control groupThe control group received routine care |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- aged 20-64
- were Chinese speaking or Taiwanese speaking;
- diagnosed with schizophrenia or schizoaffective disorder
- recent history of non-adherence to antipsychotic medication.
- demonstrated cognitive understanding of the research plan and provided consent.
Key exclusion criteria (4 listed)
- discharged from hospital for at least 3 months
- no intellectual disability, organic brain diseases or Cognitive impairment
- no alcohol or sub-stance abuse problems
- were not attending medication management program .
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 |
|---|---|---|
| Adherence TherapyAlso: Motivational interviewingMotivational interviewing-based AT in this study was based on Chien et al., (2016) and Gray et al., (2010) eight-session AT using the motivational interviewing technique (and principles of cognitive behavioral therapy). | Behavioural | experimental group |
| control groupThe control group received routine care | Behavioural | control group |
Primary outcome
Medication Adherence Rating Scale
Time frame: for two study groups at baseline(T0) and after 4 session interim analysis (T1；9-12 weeks) and 8 session after intervention (T2；21-28 weeks).
The Medication Adherence Rating Scale was developed by Thompson et al. (2000). It evaluates the adherence behavior and attitude of the patient within the previous week. There are 10 close-ended questions (yes/no answers) in the questionnaire.
3 secondary outcomes
Schedule for the Assessment of Insight, SAI
Time frame: for two study groups at baseline(T0) and after 4 session interim analysis(T1；9-12 weeks) and 8 session after intervention(T2；21-28 weeks).
Positive and Negative Syndrome Scale, PANSS
Time frame: for two study groups at baseline(T0) and after 4 session interim analysis(T1；9-12 weeks) and 8 session after intervention(T2；21-28 weeks).
Self-Appraisal of Illness Questionnaire, SAIQ
Time frame: for two study groups at baseline(T0) and after 4 session interim analysis(T1；9-12 weeks) and 8 session after intervention(T2；21-28 weeks).
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 7 Mar 2024.
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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.
Yan Laing Chen, BSN study chair
Institute of Community Health Care National Yang-Ming University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adherence Therapy in people with Motivational Interviewing and Schizophrenia Spectrum Disorder, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 4 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 7 Mar 2024. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 Rating Scale (time frame: for two study groups at baseline(T0) and after 4 session interim analysis (T1；9-12 weeks) and 8 session after intervention (T2；21-28 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2024.