Mild Cognitive Impairment (MCI)NCT07469618
Efficacy of Cognitive Stimulation Therapy Integrated With Stress Reduction Intervention for Adults With Mild Cognitive Impairment
A study testing Cognitive Stimulation Therapy integrated with Stress Reduction Intervention and Cognitive Stimulation Therapy in people with Mild Cognitive Impairment (MCI), run by University of the Punjab.
Trial summary
The aim of this study is to determine if integrating a culturally congruent indigenous stress reduction intervention into Cognitive Stimulation Therapy (CST) enhances cognitive outcomes in Pakistani adults with Mild Cognitive Impairment (MCI). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Cognitive Stimulation Therapy integrated with Stress Reduction Intervention and Cognitive Stimulation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Jun 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 45 years and above
- Individuals with education up to Matric
- Individuals who obtain a score lower than 23 on Montreal Cognitive Assessment (MoCA) suggesting the presence of cognitive decline.
- Individuals who obtain a score of 14 or more on the Perceived Stress Scale suggesting increased levels of perceived stress (moderate and high)
- Individuals who obtain score ranged from 13 to 25 (Poor to Adequate) on Quality of Life in Alzheimer's Disease (Qol-AD)
Who cannot join
- Diagnosis of dementia or major neurocognitive disorder
- Presence of severe psychiatric illness (e.g., psychosis, major depressive episode)
- Significant hearing or visual impairments that interfere with participation
- Currently undergoing psychological or cognitive therapy
- Any neurological condition that may interfere with cognitive assessment (e.g., stroke, Parkinson's disease)
About this study
The aim of this study is to determine if integrating a culturally congruent indigenous stress reduction intervention into Cognitive Stimulation Therapy (CST) enhances cognitive outcomes in Pakistani adults with Mild Cognitive Impairment (MCI).
Read the detailed description
Mild Cognitive Impairment (MCI) is characterized by noticeable decline in cognitive functioning that is greater than expected for normal aging but does not significantly interfere with daily functioning. Cognitive Stimulation Therapy (CST) has been shown to improve cognitive functioning through structured activities that stimulate memory, attention, and problem-solving abilities. However, psychological stress is an important factor that may contribute to cognitive decline and reduced engagement in cognitive activities. The present randomized controlled trial aims to evaluate whether integrating a culturally congruent indigenous stress reduction intervention with CST enhances cognitive outcomes and reduces perceived stress among Pakistani adults with MCI. Participants will be randomly assigned to one of three groups: (1) CST integrated with a CBT-based stress reduction intervention, (2) CST only, and (3) a no-intervention control group. The interventions will be delivered over a period of seven weeks. Cognitive functioning will be assessed using the Montreal Cognitive Assessment (MoCA), and perceived stress will be assessed using the Perceived Stress Scale (PSS). Assessments will be conducted at baseline and after completion of the intervention period. The study aims to determine whether the integrated intervention provides greater benefits in improving cognitive functioning as compared to CST alone.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Cognitive Stimulation Therapy integrated with Stress Reduction Intervention, Cognitive Stimulation Therapy
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Stimulation Therapy integrated with Stress Reduction InterventionBehavioural
Participants in this Arm will receive Cognitive Stimulation Therapy integrated with Stress Reduction Intervention for 7 weeks, combining structured cognitive exercises targeting memory, attention, and problem-solving with guided stress reduction techniques.
Cognitive Stimulation TherapyBehavioural
Participants in this Arm will attend Cognitive Stimulation Therapy sessions only for 7 weeks, including structured cognitive exercises targeting memory, attention, and problem-solving in a group format.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Stimulation Therapy integrated with Stress Reduction Intervention | Experimental | Participants receive Cognitive Stimulation Therapy integrated with Stress Reduction Intervention for 7 weeks. Receives: Behavioral: Cognitive Stimulation Therapy integrated with Stress Reduction Intervention |
| Cognitive Stimulation Therapy (CST) | Active comparator | Participants receive Cognitive Stimulation Therapy sessions for 7 weeks. Receives: Behavioral: Cognitive Stimulation Therapy |
| Control Group | No intervention | Participants will not receive any structured therapy during the 7 week study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montreal Cognitive Assessment (MoCA) total score from baseline to 7 weeks
The Montreal Cognitive Assessment (MoCA) will be used to assess overall cognitive functioning, including attention, memory, language, executive functions, and visuospatial abilities. The MoCA total score ranges from 0 to 30, with higher scores indicating better cognitive functioning. Assessments will be conducted at baseline and after completion of the 7-week intervention period.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Punjab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saliha Moazzam, University of the Punjab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469618
- Sponsor's protocol ID
- D/14/FIMS
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cognitive Stimulation Therapy Integrated With Stress Reduction Intervention for Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07469618
- Acronym / sponsor ID
- D/14/FIMS
- Conditions
- Mild Cognitive Impairment (MCI)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of the PunjabUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Mar 2026 (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.
The aim of this study is to determine if integrating a culturally congruent indigenous stress reduction intervention into Cognitive Stimulation Therapy (CST) enhances cognitive outcomes in Pakistani adults with Mild Cognitive Impairment (MCI).
Detailed description
Mild Cognitive Impairment (MCI) is characterized by noticeable decline in cognitive functioning that is greater than expected for normal aging but does not significantly interfere with daily functioning. Cognitive Stimulation Therapy (CST) has been shown to improve cognitive functioning through structured activities that stimulate memory, attention, and problem-solving abilities. However, psychological stress is an important factor that may contribute to cognitive decline and reduced engagement in cognitive activities. The present randomized controlled trial aims to evaluate whether integrating a culturally congruent indigenous stress reduction intervention with CST enhances cognitive outcomes and reduces perceived stress among Pakistani adults with MCI. Participants will be randomly assigned to one of three groups: (1) CST integrated with a CBT-based stress reduction intervention, (2) CST only, and (3) a no-intervention control group. The interventions will be delivered over a period of seven weeks. Cognitive functioning will be assessed using the Montreal Cognitive Assessment (MoCA), and perceived stress will be assessed using the Perceived Stress Scale (PSS). Assessments will be conducted at baseline and after completion of the intervention period. The study aims to determine whether the integrated intervention provides greater benefits in improving cognitive functioning as compared to CST alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Stimulation Therapy integrated with Stress Reduction Intervention | Experimental | Behavioral: Cognitive Stimulation Therapy integrated with Stress Reduction InterventionParticipants receive Cognitive Stimulation Therapy integrated with Stress Reduction Intervention for 7 weeks. |
| Cognitive Stimulation Therapy (CST) | Active comparator | Behavioral: Cognitive Stimulation TherapyParticipants receive Cognitive Stimulation Therapy sessions for 7 weeks. |
| Control Group | No intervention | –Participants will not receive any structured therapy during the 7 week study period. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 45 years and above
- Individuals with education up to Matric
- Individuals who obtain a score lower than 23 on Montreal Cognitive Assessment (MoCA) suggesting the presence of cognitive decline.
- Individuals who obtain a score of 14 or more on the Perceived Stress Scale suggesting increased levels of perceived stress (moderate and high)
- Individuals who obtain score ranged from 13 to 25 (Poor to Adequate) on Quality of Life in Alzheimer's Disease (Qol-AD)
Key exclusion criteria (5 listed)
- Diagnosis of dementia or major neurocognitive disorder
- Presence of severe psychiatric illness (e.g., psychosis, major depressive episode)
- Significant hearing or visual impairments that interfere with participation
- Currently undergoing psychological or cognitive therapy
- Any neurological condition that may interfere with cognitive assessment (e.g., stroke, Parkinson's disease)
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 |
|---|---|---|
| Cognitive Stimulation Therapy integrated with Stress Reduction InterventionParticipants in this Arm will receive Cognitive Stimulation Therapy integrated with Stress Reduction Intervention for 7 weeks, combining structured cognitive exercises targeting memory, attention, and problem-solving with guided stress reduction techniques. | Behavioural | Cognitive Stimulation Therapy integrated with Stress Reduction Intervention |
| Cognitive Stimulation TherapyParticipants in this Arm will attend Cognitive Stimulation Therapy sessions only for 7 weeks, including structured cognitive exercises targeting memory, attention, and problem-solving in a group format. | Behavioural | Cognitive Stimulation Therapy (CST) |
Primary outcome
Change in Montreal Cognitive Assessment (MoCA) total score from baseline to 7 weeks
Time frame: 7 weeks
The Montreal Cognitive Assessment (MoCA) will be used to assess overall cognitive functioning, including attention, memory, language, executive functions, and visuospatial abilities. The MoCA total score ranges from 0 to 30, with higher scores indicating better cognitive functioning. Assessments will be conducted at baseline and after completion of the 7-week intervention period.
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 13 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Stimulation Therapy integrated with Stress Reduction Intervention and Cognitive Stimulation Therapy in people with Mild Cognitive Impairment (MCI), run by University of the Punjab.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Montreal Cognitive Assessment (MoCA) total score from baseline to 7 weeks (time frame: 7 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 13 Mar 2026.