An interventional study of Integrative Mindfulness Enhanced Neuropsychotherapy (IMENP) in Traumatic Brain Injury (TBI) Patients, Cognitive Impairment and Depression Disorder, sponsored by University of Madras. Completed at 1 site in India. Open to participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by University of Madras · Not applicable, Interventional, and Treatment
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:
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
Traumatic Brain Injury (TBI) is defined as an alteration in brain function caused by an external force. Post TBI, individuals face long term physical, behavioural, psychological, and financial burdens that significantly influence their overall quality of life. Beyond physical rehabilitation, TBI is frequently associated with psychiatric comorbidities including depression, anxiety, fatigue, and cognitive impairment, which compromise daily functioning and the ability to reintegrate into work and family life.
Existing interventions such as Cognitive Behaviour Therapy, Mindfulness Based Stress Reduction, Acceptance and Commitment Therapy, and cognitive remediation programmes each address specific emotional or cognitive sequelae of TBI in isolation. No existing intervention integrates neuropsychological rehabilitation, mindfulness based emotional regulation, and emotion focused psychotherapy within a single coherent therapeutic framework tailored specifically for TBI rehabilitation.
IMENP was developed to address this gap through a two phase study design. Phase I used a mixed methods sequential explanatory design to establish clinical need and develop the intervention. Part A involved a cross sectional survey of 74 TBI patients assessing neurocognitive functioning and quality of life. Part B involved semi structured interviews with TBI patients and clinical experts to identify key challenges, barriers, and intervention components. Six themes were identified through thematic analysis: challenges, psychological aspects, barriers, importance and perception, efficiency and outcome, and future recommendations. Part C involved expert validation of the developed intervention module using a Content Validity Index with six clinical experts rating each activity on a five point scale.
The 16 session IMENP programme developed from Phase I findings incorporates four core components:
Psychoeducation about TBI and neuroplasticity Mindfulness based emotional regulation including self compassion meditation, loving kindness meditation, grounding exercises, and the RAIN practice Neuropsychological cognitive rehabilitation targeting attention, memory, and executive functioning Emotion focused psychotherapy including identification and restructuring of maladaptive cognitive affective sequences
Sessions were delivered twice weekly over three months with individual sessions at Sessions 2, 8, and 16 for personalised goal formulation and review. Between session homework tasks were incorporated to sustain engagement and consolidate therapeutic gains.
Phase II evaluated IMENP effectiveness using a randomised waitlist controlled design. 68 participants with mild to moderate TBI aged 18 to 44 years were randomised to the experimental group (n=33) or waitlist control group (n=34). Outcome measures assessed at baseline, post intervention at three months, and one month follow up included neurocognitive functioning (Montreal Cognitive Assessment), quality of life (WHOQOL-BREF), depression (PHQ-9), and fatigue (Fatigue Severity Scale). Analyses of covariance with pre test scores as covariates were used to examine between group differences. Waitlist control participants received treatment as usual during the intervention period and were provided three introductory IMENP sessions following study completion as an ethical measure to ensure equitable access to the intervention.
1,818 studies on the registry are indexed under Brain Injuries, Traumatic; 460 are open to participants now.
This study's enrollment of 68 is above the median of 55 across 1,158 interventional studies indexed under Brain Injuries, Traumatic.
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Exclusion Criteria:
Participants received 16 sessions of Integrative Mindfulness Enhanced Neuropsychotherapy (IMENP) delivered twice weekly over three months
Behavioral: Integrative Mindfulness Enhanced Neuropsychotherapy (IMENP)
Participants received treatment as usual during the three month intervention period and were provided three introductory IMENP sessions following study completion
16 session structured psychological intervention delivered twice weekly over three months incorporating mindfulness based emotional regulation, neuropsychological cognitive rehabilitation, emotion focused psychotherapy and psychoeducation
Also known as: IMENP, Mindfulness Enhanced Neuropsychotherapy, Integrative Neuropsychotherapy
Neurocognitive Functioning assessed by Montreal Cognitive Assessment (MoCA)
Assessed using the Montreal Cognitive Assessment (MoCA). The MoCA assesses multiple cognitive domains including attention, concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Scores range from 0 to 30 with higher scores indicating better cognitive functioning. The assessor completed formal MoCA training prior to administration. Written permission to use and publish the MoCA in this study was obtained from the MoCA team.
Time frame: Baseline, post intervention at 3 months, and one month follow up
World Health Organization Quality of Life (WHOQOL-BREF) Total and Domain Scores
Assessed using the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) across four domains: physical, psychological, social, and environmental. Domain scores range from a minimum of 4 to a maximum of 20. Higher scores indicate better quality of life.
Time frame: Baseline, post intervention at 3 months, and one month follow up
Depression assessed by Patient Health Questionnaire (PHQ-9)
Assessed using the Patient Health Questionnaire (PHQ-9). Scores range from 0 to 27 with higher scores indicating greater depression severity
Time frame: Post intervention at 3 months, and one month follow up
Fatigue assessed by Fatigue Severity Scale (FSS)
Assessed using the Fatigue Severity Scale (FSS). Scores range from 9 to 63 with higher scores indicating greater fatigue severity
Time frame: Post intervention at 3 months, and one month follow up
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified individual participant data underlying the results reported in this study will be made available following publication, including data for the primary outcome measure (Montreal Cognitive Assessment) and secondary outcome measures (WHOQOL-BREF, PHQ-9, FSS). Demographic data will also be shared in de-identified form.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 6 months after publication and available for 5 years following publication date
Access criteria: De-identified individual participant data and supporting documents will be available to researchers who provide a methodologically sound proposal. Requests should be directed to the corresponding author at p.dhandapani@keele.ac.uk and should include the proposed research question and intended use of the data. Data will be shared subject to institutional ethical approval from the requesting institution and a signed data sharing agreement. Data will be provided in csv format.
Data sharing details ↗ · osf.io
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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