Traumatic Brain Injury (TBI) PatientsIMENPNCT07874685
Mindfulness-Integrated Neuropsychotherapy for Traumatic Brain Injury: A Mixed-Methods Evaluation of Cognitive and Psychosocial Recovery
A study testing Integrative Mindfulness Enhanced Neuropsychotherapy (IMENP) in people with Traumatic Brain Injury (TBI) Patients and Cognitive Impairment, run by University of Madras at 1 site in India.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Traumatic Brain Injury (TBI) Patients, Cognitive Impairment, Depression Disorder
- What is being tested?
- Integrative Mindfulness Enhanced Neuropsychotherapy (IMENP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteIndia
- Study dates
- 6 Nov 2023to 16 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed diagnosis of any form of Traumatic Brain Injury (TBI)
- Age range of 18 to 44 years (both male and female)
- Elapsed time since injury of at least one year
- Glasgow Coma Scale (GCS) score greater than 9 at the time of admission
- Intact language comprehension ability
- Moderate level of neurocognitive functioning and quality of life on baseline assessment
- Willingness to provide informed consent to participate in the IMENP intervention programme
Who cannot join
- Prior history of neurological disease such as epilepsy, dementia or Parkinson's disease
- Diagnosed substance use disorder
- Currently undergoing psychological intervention or diagnosed with a psychiatric disorder
- Severe TBI or GCS score of 9 or below at time of admission
- Cognitive impairment severe enough to preclude informed consent
Trial locations and contacts
1 site in 1 country.
India1 site
Location 1- HAMSA Rehab, Location 2- JH rehab, Location 3- VHS center
Chennai, Tamil Nadu, 600005
About this study
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?
Read more
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
Read the detailed description
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.
- Conditions
- Traumatic Brain Injury (TBI) Patients, Cognitive Impairment, Depression Disorder, Fatigue Severity Scale, Quality of Life (QOL)
- Being tested
- Integrative Mindfulness Enhanced Neuropsychotherapy (IMENP)
- Keywords
- Traumatic Brain Injury, TBI rehabilitation, Neuropsychotherapy, Mindfulness, IMENP, Neurocognitive functioning, Quality of life, Depression, Fatigue
- Medical subject headings
- Brain Injuries, Traumatic, Cognitive Dysfunction, Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative Mindfulness Enhanced Neuropsychotherapy (IMENP)Behavioural
Also called IMENP, Mindfulness Enhanced Neuropsychotherapy, Integrative Neuropsychotherapy
16 session structured psychological intervention delivered twice weekly over three months incorporating mindfulness based emotional regulation, neuropsychological cognitive rehabilitation, emotion focused psychotherapy and psychoeducation
| Study group | Role | What they receive |
|---|---|---|
| IMENP Experimental Group | Experimental | Participants received 16 sessions of Integrative Mindfulness Enhanced Neuropsychotherapy (IMENP) delivered twice weekly over three months Receives: Behavioral: Integrative Mindfulness Enhanced Neuropsychotherapy (IMENP) |
| Waitlist Control Group | No intervention | Participants received treatment as usual during the three month intervention period and were provided three introductory IMENP sessions following study completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, post intervention at 3 months, and one month follow up
Secondary outcomes (2)
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
Measured: 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
Measured: Post intervention at 3 months, and one month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start6 Nov 2023
- Primary completion31 Jan 2024
- Study completion16 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain Injury (TBI) PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised waitlist controlled parallel group design. Participants were randomly assigned to either the IMENP experimental group or a waitlist control group. Both groups were assessed at the same time points.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Madras
- Sponsor type
- University, hospital or other
- Collaborators
- Keele University
- Responsible party
- Principal investigator, Priya Dhandapani, Keele University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874685
- Sponsor's protocol ID
- CCDO/ICMR/EC/2022/02
- Acronym
- IMENP
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Dhandapani P & Somasundharam T (2023). Development of Integrative Mindfulness Enhanced Neuro-Psychotherapy intervention module for Traumatic Brain Injured (TBI) Patients. Indian Journal of Clinical Psychology, 50(03), 78-83.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Integrated Neuropsychotherapy for Traumatic Brain Injury: A Mixed-Methods Evaluation of Cognitive and Psychosocial Recovery
- ClinicalTrials.gov ID
- NCT07874685
- Acronym / sponsor ID
- IMENP / CCDO/ICMR/EC/2022/02
- Conditions
- Traumatic Brain Injury (TBI) Patients, Cognitive Impairment, Depression Disorder, Fatigue Severity Scale, Quality of Life (QOL)
- Keywords
- Traumatic Brain Injury, TBI rehabilitation, Neuropsychotherapy, Mindfulness, IMENP, Neurocognitive functioning, Quality of life, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of MadrasUniversity, hospital or other
- Collaborators
- Keele University
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 16 Jun 2024 (actual)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised waitlist controlled parallel group design. Participants were randomly assigned to either the IMENP experimental group or a waitlist control group. Both groups were assessed at the same time points.
| Arm | Type | Receives |
|---|---|---|
| IMENP Experimental Group | Experimental | Behavioral: Integrative Mindfulness Enhanced Neuropsychotherapy (IMENP)Participants received 16 sessions of Integrative Mindfulness Enhanced Neuropsychotherapy (IMENP) delivered twice weekly over three months |
| Waitlist Control Group | No intervention | –Participants received treatment as usual during the three month intervention period and were provided three introductory IMENP sessions following study completion |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Confirmed diagnosis of any form of Traumatic Brain Injury (TBI)
- Age range of 18 to 44 years (both male and female)
- Elapsed time since injury of at least one year
- Glasgow Coma Scale (GCS) score greater than 9 at the time of admission
- Intact language comprehension ability
Key exclusion criteria (5 listed)
- Prior history of neurological disease such as epilepsy, dementia or Parkinson's disease
- Diagnosed substance use disorder
- Currently undergoing psychological intervention or diagnosed with a psychiatric disorder
- Severe TBI or GCS score of 9 or below at time of admission
- Cognitive impairment severe enough to preclude informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative Mindfulness Enhanced Neuropsychotherapy (IMENP)Also: IMENP, Mindfulness Enhanced Neuropsychotherapy, Integrative Neuropsychotherapy16 session structured psychological intervention delivered twice weekly over three months incorporating mindfulness based emotional regulation, neuropsychological cognitive rehabilitation, emotion focused psychotherapy and psychoeducation | Behavioural | IMENP Experimental Group |
Primary outcome
Neurocognitive Functioning assessed by Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, post intervention at 3 months, and one month follow up
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.
World Health Organization Quality of Life (WHOQOL-BREF) Total and Domain Scores
Time frame: Baseline, post intervention at 3 months, and one month follow up
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.
2 secondary outcomes
Depression assessed by Patient Health Questionnaire (PHQ-9)
Time frame: Post intervention at 3 months, and one month follow up
Fatigue assessed by Fatigue Severity Scale (FSS)
Time frame: Post intervention at 3 months, and one month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Results publicationDhandapani P & Somasundharam T (2023). Development of Integrative Mindfulness Enhanced Neuro-Psychotherapy intervention module for Traumatic Brain Injured (TBI) Patients. Indian Journal of Clinical Psychology, 50(03), 78-83.
- Keele University School of PsychologyLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative Mindfulness Enhanced Neuropsychotherapy (IMENP) in people with Traumatic Brain Injury (TBI) Patients and Cognitive Impairment, run by University of Madras at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive Functioning assessed by Montreal Cognitive Assessment (MoCA) (time frame: Baseline, post intervention at 3 months, and one month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07874685, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.