Efficacy of Cognitive Stimulation Therapy Integrated With Stress Reduction Intervention for Adults With Mild Cognitive Impairment

March 10, 2026 updated by: Saliha Moazzam, University of the Punjab
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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Stimulation Therapy integrated with Stress Reduction Intervention
Participants receive Cognitive Stimulation Therapy integrated with Stress Reduction Intervention for 7 weeks.
Behavioral: Cognitive Stimulation Therapy integrated with Stress Reduction Intervention
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.
Active Comparator: Cognitive Stimulation Therapy (CST)
Participants receive Cognitive Stimulation Therapy sessions for 7 weeks.
Behavioral: Cognitive Stimulation Therapy
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.
No Intervention: Control Group
Participants will not receive any structured therapy during the 7 week study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Punjab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D/14/FIMS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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