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Life sciences · Interventional Study
ClinicalTrials.gov · October 15, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07874685). This is a study registration, not published results. Lead sponsor: University of Madras. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 68 participants (ACTUAL). Conditions: Traumatic Brain Injury (TBI) Patients, Cognitive Impairment, Depression Disorder, Fatigue Severity Scale, Quality of Life (QOL). Interventions: BEHAVIORAL: Integrative Mindfulness Enhanced Neuropsychotherapy (IMENP). Primary outcome measures: Neurocognitive Functioning assessed by Montreal Cognitive Assessment (MoCA) , Baseline, post intervention at 3 months, and one month follow up; World Health Organization Quality of Life (WHOQOL-BREF) Total and Domain Scores , Baseline, post intervention at 3 months, and one month follow up. Brief summary: The goal of this clinical trial is to test the effectiveness of Integrative Mindfulness Enhanced Neuropsychotherapy (IMENP) in improving neurocognitive functioning and wellbeing among adults aged 18 to 44 years with mild to moderate Traumatic Brain Injury (TBI). The main questions it aims to answer are: * Does IMENP improve neurocognitive functioning in individuals with mild to moderate TBI? * Does IMENP improve quality of life, and reduce depression and fatigue in individuals with mild to moderate TBI? Researchers will compare participants who receive the 16 session IMENP programme to participants on a waitlist control condition to see if IMENP improves cognitive functioning and overall wellbeing. Participants in the experimental group will: Attend 16 sessions of IMENP delivered twice weekly over three months Complete mindfulness practices, cognitive rehabilitation exercises, and emotional regulation techniques during sessions Complete between session homework tasks including expressive writing, mindful activities, and reflective exercises Be assessed on neurocognitive functioning, quality of life, depression, and fatigue at baseline, post intervention, and one month follow up Participants in the waitlist control group will: Receive treatment as usual during the three month intervention period Be assessed at the same time points as the experimental group Receive three introductory IMENP sessions following study completion