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Not yet recruiting NCT07469618

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

No phase Interventional Mild Cognitive Impairment (MCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive Stimulation Therapy integrated with Stress Reduction Intervention, Cognitive Stimulation Therapy.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment (MCI). Basic parameters: from 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Change in Montreal Cognitive Assessment (MoCA) total score from baseline to 7 weeks [Time frame: 7 weeks]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07469618 · D/14/FIMS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗