Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-29 @ 11:58 PM
Study NCT ID:
NCT07469618
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Cognitive Stimulation Therapy Integrated With Stress Reduction Intervention for Adults With Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Montreal Cognitive Assessment (MoCA) total score from baseline to 7 weeks', 'timeFrame': '7 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment (MCI)']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 45 years and above\n* Individuals with education up to Matric\n* Individuals who obtain a score lower than 23 on Montreal Cognitive Assessment (MoCA) suggesting the presence of cognitive decline.\n* Individuals who obtain a score of 14 or more on the Perceived Stress Scale suggesting increased levels of perceived stress (moderate and high)\n* Individuals who obtain score ranged from 13 to 25 (Poor to Adequate) on Quality of Life in Alzheimer's Disease (Qol-AD)\n\nExclusion Criteria:\n\n* Diagnosis of dementia or major neurocognitive disorder\n* Presence of severe psychiatric illness (e.g., psychosis, major depressive episode)\n* Significant hearing or visual impairments that interfere with participation\n* Currently undergoing psychological or cognitive therapy\n* Any neurological condition that may interfere with cognitive assessment (e.g., stroke, Parkinson's disease)"}, 'identificationModule': {'nctId': 'NCT07469618', 'briefTitle': 'Efficacy of Cognitive Stimulation Therapy Integrated With Stress Reduction Intervention for Adults With Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'University of the Punjab'}, 'officialTitle': 'Efficacy of Cognitive Stimulation Therapy Integrated With Stress Reduction Intervention for Adults With Mild Cognitive Impairment', 'orgStudyIdInfo': {'id': 'D/14/FIMS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Stimulation Therapy integrated with Stress Reduction Intervention', 'description': 'Participants receive Cognitive Stimulation Therapy integrated with Stress Reduction Intervention for 7 weeks.', 'interventionNames': ['Behavioral: Cognitive Stimulation Therapy integrated with Stress Reduction Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Stimulation Therapy (CST)', 'description': 'Participants receive Cognitive Stimulation Therapy sessions for 7 weeks.', 'interventionNames': ['Behavioral: Cognitive Stimulation Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants will not receive any structured therapy during the 7 week study period.'}], 'interventions': [{'name': 'Cognitive Stimulation Therapy integrated with Stress Reduction Intervention', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Cognitive Stimulation Therapy integrated with Stress Reduction Intervention']}, {'name': 'Cognitive Stimulation Therapy', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Cognitive Stimulation Therapy (CST)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of the Punjab', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Student', 'investigatorFullName': 'Saliha Moazzam', 'investigatorAffiliation': 'University of the Punjab'}}}}