SchizophreniaNCT06474195
Cue-based Intervention in Prospective Memory and Medication Adherence.
A study testing Cue based intervention and Treatment as Usual in people with Schizophrenia, run by University of Pittsburgh at 1 site in India.
Trial summary
Medication adherence is a major challenge while treating patients with major mental illnesses like schizophrenia and schizoaffective disorder. This interventional study aims to assess the improvement in prospective memory and thus medication adherence by giving time and event-based cues to the participants. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cue based intervention and Treatment as Usual
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jun 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and Female age 18 - 60 years
- Diagnosed with Schizophrenia as per DSM V Criteria
- Insight of grade 3 or more.
- At least 10th standard level of education in the English language
Who cannot join
- Comorbid chronic medical illnesses.
- Psychoactive substance use in harmful use pattern or in dependence pattern.
- Co-existing neurodevelopmental disorders or learning disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Cue-based Intervention in Improving Prospective Memory by Enhancing Medication Adherence in Patients With Schizophrenia and Schizoaffective Disorder: A Randomized Controlled Trial
Medication adherence is a major challenge while treating patients with major mental illnesses like schizophrenia and schizoaffective disorder. This interventional study aims to assess the improvement in prospective memory and thus medication adherence by giving time and event-based cues to the participants.
Read the detailed description
According to available evidence, prospective memory (PM) is important in daily functioning but is impaired in schizophrenia. However, there were hardly any Indian studies on this topic. Medication adherence is one of the challenges which clinicians often face during treatment. Our study aims to enhance medication adherence and prospective memory using a cue-based intervention.
Aims:
To assess the improvement in prospective memory using cue-based intervention to enhance medication adherence and basic functional skills.
Objective:
- To correlate prospective memory and medication adherence with executive function and cognitive insight.
- To correlate the medication adherence with basic functional skills
Hypotheses to be tested:
- Statistically significant difference between prospective memory improvement with intervention in the intervention group and treatment as usual group.
- A Statistically significant correlation between prospective memory score and medication adherence score.
- A Statistically significant correlation between medication adherence and basic functional skills.
The study will have two arms with two arms (n=52 in each group) the intervention arm and the TAU arm. Participants in both arms will receive standard medical care as advised by the treating psychiatrist. The treating psychiatrist will be blinded about which group the patient belongs to and they will be encouraged to prescribe stable medication throughout the study process unless it would affect the treatment outcome or prognosis of the patient. The intervention arm will receive the cues in the form of daily repeating reminders for a time period of 30 days. The reminders will be set on participants' mobile phone to receive at least 1 hour prior to the prescribed oral antipsychotic medication. The same reminder will be repeated after 10minutes duration to ensure that participant does not miss the cue and the uniformity of the cue will be ensured by setting the same emoji or the same phrase on the participants own mobile phone. The participants will also be encouraged to close their eyes for 5-7 seconds and imagine themselves to be taking the medication at the prescribed time when they see the reminder. The family members or the caretaker of the patient will be provided with a adherence chart which will be reviewed during the follow up visits. During the baseline assessment Independent Living Skills Survey (ILSS) questionnaire will be administered to obtain a baseline score of living skills and the domain with least score will be addressed by individual based intervention using similar cue-based intervention by repeated reminders will be done to improve that domain and during the follow up visit the improvement will be assessed by comparing the follow up scores of (ILSS) with baseline scores. Subsequently on first follow up the medication adherence will be assessed using Brief Adherence Rating Scale (BARS) and prospective memory will be assessed using Memory for Intentions Screening Test (MIST) and the score will be briefed to the patients and patients will be motivated to comply with study process till the second follow up. The second follow up assessment will be done after 90 days from baseline assessment. During the time period between first and second follow up the participants will not receive any cue. Participants will be assessed using Memory for Intentions Screening Test (MIST), Brief Adherence Rating Scale (BARS), Trail Making Test (TMT), Beck Cognitive Insight Scale (BCIS) and Independent Living Skills Survey (ILSS) during baseline, first follow up and second follow up. During each sessions patients as well as family will be enquired if they suffered from any distress related to the study, both psychological and physical. In that case it will be explored in detail and if required necessary intervention will be given after after consulting with the treating psychiatrists.
- Conditions
- Schizophrenia
- Being tested
- Cue based intervention, Treatment as Usual
- Keywords
- Adherence, Schizophrenia, Cue based
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cue based interventionBehavioural
The intervention arm will receive the cues in the form of daily repeating reminders for a time period of 30 days. The reminders will be set on participants' mobile phones to receive at least 1 hour prior to the prescribed oral antipsychotic medication. The same reminder will be repeated after 10 minutes duration to ensure that the participant does not miss the cue and the uniformity of the cue will be ensured by setting the same emoji or the same phrase on the participant's own mobile phone. The participant will also be asked a task of daily routine during the same time of medication.
Treatment as UsualBehavioural
Also called TAU
This group will not get any intervention but the usual treatment all assessments will continue
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | . The intervention arm will receive the cues in the form of daily repeating reminders for a time period of 30 days. The reminders will be set on participants' mobile phones to receive at least 1 hour prior to the prescribed oral antipsychotic medication. The same reminder will be repeated after 10 minutes duration to ensure that the participant does not miss the cue and the uniformity of the cue will be ensured by setting the same emoji or the same phrase on the participant's own mobile phone. The participant will also be asked a task of daily routine during the same time of medication. Receives: Behavioral: Cue based intervention |
| Treatment as Usual | Active comparator | Treatment as Usual (TAU) Arm will not get any reminders but the baseline assessment will be similar to the intervention arm. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospective memory
Change in prospective memory in intervention arm as measured by compared to TAU The Memory for Intentions Screening Test(MIST) score as compared to TAU
Measured: Baseline, After 30days' intervention
Prospective memory (sustainability)
Change in prospective memory in intervention arm as measured by compared to TAU The Memory for Intentions Screening Test (MIST) score as compared to TAU
Measured: Baseline, 90 days after baseline assessment
Medication adherence
Change in medication adherence in intervention arm as measured by Brief Adherence Rating Scale (BARS) score as compared to TAU
Measured: Baseline, After 30days' intervention
Medication adherence (Sustainability)
Change in medication adherence in intervention arm as measured by Brief Adherence Rating Scale (BARS) score as compared to TAU
Measured: Baseline, 90 days after baseline assessment
Secondary outcomes (6)
Cognition
Change in cognition in intervention arm as measured by Trail Making Test (TMT) score as compared to TAU
Measured: Baseline, After 30days' intervention
Cognition (Sustainability)
Change in cognition in intervention arm as measured by Trail Making Test (TMT) score as compared to TAU
Measured: Baseline, 90 days after baseline assessment
Independent living skills score
Change in Independent living skills score in intervention arm as measured by Independent living skills scale (ILSS) score as compared to TAU
Measured: Baseline, After 30days' intervention
Independent living skills score (Sustainability)
Change in Independent living skills score in intervention arm as measured by Independent living skills scale (ILSS) score as compared to TAU
Measured: Baseline, 90 days after baseline assessment
Cognitive Insight
Change in Independent living skills score in intervention arm as measured by Cognitive Insight Scale (BCIS) score as compared to TAU
Measured: Baseline, After 30days' intervention
Cognitive Insight (Sustainabilty)
Change in Independent living skills score in intervention arm as measured by Cognitive Insight Scale (BCIS) score as compared to TAU
Measured: Baseline,90 days after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start15 Jun 2024
- Primary completion15 Nov 2025
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled study. The participants will be randomly assigned to treatment as usual arm or intervention arm. The intervention arm will receive the cues in the form of daily repeating reminders for a time period of 30 days. The participant will also be asked a task of daily routine during the same time of medication. The Treatment as Usual (TAU) Arm will not get any reminders but the baseline assessment will be similar to the intervention arm. There will be 2 follow-ups, 1st follow-up will be 30 days after the baseline assessment and the second will be 90 days after the baseline assessment. repeated during both follow-up visits. TAU will also be followed up at 30 days and 90 days after baseline assessment.
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, St.John's Medical College and Hospital
- Responsible party
- Principal investigator, Vishwajit Nimgaonkar, MD PhD, University of Pittsburgh
- Investigators
- Vishwajit L Nimgaonkar, MD, PhD, Principal investigator, University of Pittburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474195
- Sponsor's protocol ID
- STUDY22120098
- Other IDs
- D43TW009114
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cue-based Intervention in Improving Prospective Memory by Enhancing Medication Adherence in Patients With Schizophrenia and Schizoaffective Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06474195
- Acronym / sponsor ID
- STUDY22120098
- Conditions
- Schizophrenia
- Keywords
- Adherence, Schizophrenia, Cue based
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, St.John's Medical College and Hospital
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 25 Jun 2024 (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.
Medication adherence is a major challenge while treating patients with major mental illnesses like schizophrenia and schizoaffective disorder. This interventional study aims to assess the improvement in prospective memory and thus medication adherence by giving time and event-based cues to the participants.
Detailed description
According to available evidence, prospective memory (PM) is important in daily functioning but is impaired in schizophrenia. However, there were hardly any Indian studies on this topic. Medication adherence is one of the challenges which clinicians often face during treatment. Our study aims to enhance medication adherence and prospective memory using a cue-based intervention.
Aims:
To assess the improvement in prospective memory using cue-based intervention to enhance medication adherence and basic functional skills.
Objective:
- To correlate prospective memory and medication adherence with executive function and cognitive insight.
- To correlate the medication adherence with basic functional skills
Hypotheses to be tested:
- Statistically significant difference between prospective memory improvement with intervention in the intervention group and treatment as usual group.
- A Statistically significant correlation between prospective memory score and medication adherence score.
- A Statistically significant correlation between medication adherence and basic functional skills.
The study will have two arms with two arms (n=52 in each group) the intervention arm and the TAU arm. Participants in both arms will receive standard medical care as advised by the treating psychiatrist. The treating psychiatrist will be blinded about which group the patient belongs to and they will be encouraged to prescribe stable medication throughout the study process unless it would affect the treatment outcome or prognosis of the patient. The intervention arm will receive the cues in the form of daily repeating reminders for a time period of 30 days. The reminders will be set on participants' mobile phone to receive at least 1 hour prior to the prescribed oral antipsychotic medication. The same reminder will be repeated after 10minutes duration to ensure that participant does not miss the cue and the uniformity of the cue will be ensured by setting the same emoji or the same phrase on the participants own mobile phone. The participants will also be encouraged to close their eyes for 5-7 seconds and imagine themselves to be taking the medication at the prescribed time when they see the reminder. The family members or the caretaker of the patient will be provided with a adherence chart which will be reviewed during the follow up visits. During the baseline assessment Independent Living Skills Survey (ILSS) questionnaire will be administered to obtain a baseline score of living skills and the domain with least score will be addressed by individual based intervention using similar cue-based intervention by repeated reminders will be done to improve that domain and during the follow up visit the improvement will be assessed by comparing the follow up scores of (ILSS) with baseline scores. Subsequently on first follow up the medication adherence will be assessed using Brief Adherence Rating Scale (BARS) and prospective memory will be assessed using Memory for Intentions Screening Test (MIST) and the score will be briefed to the patients and patients will be motivated to comply with study process till the second follow up. The second follow up assessment will be done after 90 days from baseline assessment. During the time period between first and second follow up the participants will not receive any cue. Participants will be assessed using Memory for Intentions Screening Test (MIST), Brief Adherence Rating Scale (BARS), Trail Making Test (TMT), Beck Cognitive Insight Scale (BCIS) and Independent Living Skills Survey (ILSS) during baseline, first follow up and second follow up. During each sessions patients as well as family will be enquired if they suffered from any distress related to the study, both psychological and physical. In that case it will be explored in detail and if required necessary intervention will be given after after consulting with the treating psychiatrists.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized controlled study. The participants will be randomly assigned to treatment as usual arm or intervention arm. The intervention arm will receive the cues in the form of daily repeating reminders for a time period of 30 days. The participant will also be asked a task of daily routine during the same time of medication. The Treatment as Usual (TAU) Arm will not get any reminders but the baseline assessment will be similar to the intervention arm. There will be 2 follow-ups, 1st follow-up will be 30 days after the baseline assessment and the second will be 90 days after the baseline assessment. repeated during both follow-up visits. TAU will also be followed up at 30 days and 90 days after baseline assessment.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Cue based intervention. The intervention arm will receive the cues in the form of daily repeating reminders for a time period of 30 days. The reminders will be set on participants' mobile phones to receive at least 1 hour prior to the prescribed oral antipsychotic medication. The same reminder will be repeated after 10 minutes duration to ensure that the participant does not miss the cue and the uniformity of the cue will be ensured by setting the same emoji or the same phrase on the participant's own mobile phone. The participant will also be asked a task of daily routine during the same time of medication. |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualTreatment as Usual (TAU) Arm will not get any reminders but the baseline assessment will be similar to the intervention arm. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and Female age 18 - 60 years
Key exclusion criteria (3 listed)
- Comorbid chronic medical illnesses.
- Psychoactive substance use in harmful use pattern or in dependence pattern.
- Co-existing neurodevelopmental disorders or learning disorders.
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 |
|---|---|---|
| Cue based interventionThe intervention arm will receive the cues in the form of daily repeating reminders for a time period of 30 days. The reminders will be set on participants' mobile phones to receive at least 1 hour prior to the prescribed oral antipsychotic medication. The same reminder will be repeated after 10 minutes duration to ensure that the participant does not miss the cue and the uniformity of the cue will be ensured by setting the same emoji or the same phrase on the participant's own mobile phone. The participant will also be asked a task of daily routine during the same time of medication. | Behavioural | Intervention |
| Treatment as UsualAlso: TAUThis group will not get any intervention but the usual treatment all assessments will continue | Behavioural | Treatment as Usual |
Primary outcome
Prospective memory
Time frame: Baseline, After 30days' intervention
Change in prospective memory in intervention arm as measured by compared to TAU The Memory for Intentions Screening Test(MIST) score as compared to TAU
Prospective memory (sustainability)
Time frame: Baseline, 90 days after baseline assessment
Change in prospective memory in intervention arm as measured by compared to TAU The Memory for Intentions Screening Test (MIST) score as compared to TAU
Medication adherence
Time frame: Baseline, After 30days' intervention
Change in medication adherence in intervention arm as measured by Brief Adherence Rating Scale (BARS) score as compared to TAU
Medication adherence (Sustainability)
Time frame: Baseline, 90 days after baseline assessment
Change in medication adherence in intervention arm as measured by Brief Adherence Rating Scale (BARS) score as compared to TAU
6 secondary outcomes
Cognition
Time frame: Baseline, After 30days' intervention
Cognition (Sustainability)
Time frame: Baseline, 90 days after baseline assessment
Independent living skills score
Time frame: Baseline, After 30days' intervention
Independent living skills score (Sustainability)
Time frame: Baseline, 90 days after baseline assessment
Cognitive Insight
Time frame: Baseline, After 30days' intervention
Cognitive Insight (Sustainabilty)
Time frame: Baseline,90 days after baseline assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
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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.
Vishwajit L Nimgaonkar, MD, PhD principal investigator
University of Pittburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cue based intervention and Treatment as Usual in people with Schizophrenia, run by University of Pittsburgh at 1 site in India.
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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. 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 India. 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?
This study is still under way. Results are not available in the source record yet.
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?
Prospective memory (time frame: Baseline, After 30days' intervention). The study lists 4 primary outcomes in all. 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 5 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.