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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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.

India1 site
  • St. John's Medical College and Hospital

    Bengaluru, Karnataka

Other trials in India

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:

  1. To correlate prospective memory and medication adherence with executive function and cognitive insight.
  2. To correlate the medication adherence with basic functional skills

Hypotheses to be tested:

  1. Statistically significant difference between prospective memory improvement with intervention in the intervention group and treatment as usual group.
  2. A Statistically significant correlation between prospective memory score and medication adherence score.
  3. 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 groups in NCT06474195
Study groupRoleWhat they receive
InterventionExperimental. 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 UsualActive comparatorTreatment 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.

  1. 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

  2. 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

  3. 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

  4. 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)
  1. Cognition

    Change in cognition in intervention arm as measured by Trail Making Test (TMT) score as compared to TAU

    Measured: Baseline, After 30days' intervention

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted25 Jun 2024
  2. Study start15 Jun 2024
  3. Primary completion15 Nov 2025
  4. Study completion30 Sep 2026 (estimated)

Resources

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)
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).

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.

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