| CTRI Number |
CTRI/2025/08/093350 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Psychological] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to find the impact of ACT-based intervention in Adults with ADHD |
|
Scientific Title of Study
|
Evaluating Functional Outcomes of Integrated Acceptance and Commitment Therapy in Adults with ADHD |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhashis Banerjee |
| Designation |
PhD Scholar |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES, Clinical Psychology Department |
| Address |
Department of Clinical Psychology, NIMHANS, M.V. Govindaswamy Centre (3rd Floor), on Hosur Road, Bangalore-560029
Department of Clinical Psychology, NIMHANS, M.V. Govindaswamy Centre (3rd Floor), on Hosur Road, Bangalore-560029.
Bangalore
KARNATAKA
560029
India |
| Phone |
6355256972 |
| Fax |
|
| Email |
subhashis1809@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Associate Professor |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES, Clinical Psychology Department |
| Address |
Department of Clinical Psychology, NIMHANS, M.V. Govindaswamy Centre (3rd Floor), on Hosur Road, Bangalore-560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9886426548 |
| Fax |
|
| Email |
ajaycog2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Associate Professor |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES, Clinical Psychology Department |
| Address |
Department of Clinical Psychology, NIMHANS, M.V. Govindaswamy Centre (3rd Floor), on Hosur Road, Bangalore-560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9886426548 |
| Fax |
|
| Email |
ajaycog2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences, Hosur Road, Bangalore, Karnataka, India
Pin code 560029 |
|
|
Primary Sponsor
|
| Name |
Subhashis Banerjee |
| Address |
NIMHANS, Thunga Hostel, Hosur Road/Marigowda Road (Lakkasandra, Wilson Garden),
Bengaluru 560029 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Subhashis Banerjee |
National Institute of Mental Health and Neuro Sciences |
Department of Clinical Psychology, M.V Govindswamy Building, 3rd Floor, Hosur Road/Marigowda Road (Lakkasandra, Wilson Garden),
Bengaluru 560029
Bangalore
KARNATAKA |
6355256972
subhashis1809@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Behavioural Science Division), NIMHANS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F90||Attention-deficit hyperactivity disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated Acceptance and Commitment Therapy |
The therapy module would include Psychoeducation for participants and a family member, Introduction to therapy, Human suffering, Language and Suffering, Experiential Avoidance, Understanding thoughts, Cognitive Defusion, Understanding Self, Mindfulness, Willingness, Values, and Committed Action. Skills that will be integrated are Problem Solving, Time management, Interpersonal Skills, Decision making and Organisation. The intervention will be covered in 12-15 sessions and will take about 2.5 to 3 months, excluding follow up. |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18-50 years
Meeting ICD-11 criteria for Adult ADHD (Based on FLII-11)
All gender
Able to read and understand the Hindi, English, and Bengali languages in which the assessments and interventions will be provided.
Participants must be drug-naive or on a stable dose for at least 8 weeks before entering the study.
|
|
| ExclusionCriteria |
| Details |
Severe mood disorders with high suicidal risk (e.g., bipolar disorder), Psychotic disorders, Schizophrenia, and Current Psychoactive substance use disorder (except nicotine) which can interfere with the assessment and intervention.
Clinical diagnosis of Autism Spectrum Disorder (ASD) or Intellectual Disability by a psychiatrist.
Presence of neurological or medical conditions that may interfere with study participation or interpretation of results (e.g., untreated epilepsy, head injury). This will be assessed clinically.
Participants who are currently undergoing structured psychotherapy for ADHD or other comorbidity or have received 6 or more sessions throughout the study period.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Functionality in Adults with ADHD
|
Pre-intervention post intervention and 3 Month Follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Severity of ADHD symptoms in adults with ADHD.
|
Pre-intervention post intervention and 3 Month Follow-up |
| Satisfaction with life. |
Pre-intervention post intervention and 3 Month Follow-up |
| Emotion regulation. |
Pre-intervention post intervention and 3 Month Follow-up |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/09/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will integrate process-based therapy, ACT, with skills from other therapies like CBT and DBT to develop an integrated ACT for adult ADHD. It will help us understand the effectiveness of intervention in improving functioning, symptoms, emotional dysregulation and life satisfaction. The study will be a single-arm open-label trial, with baseline, post-treatment, and 3-month follow-up assessments. 26 patients with a primary diagnosis of ADHD will be recruited. They will receive an integrated ACT intervention. A psychotherapeutic intervention based on Acceptance and Commitment Therapy (ACT) can be effectively integrated for adults with ADHD. The study will test the effectiveness of the intervention in reducing functional impairment, severity of ADHD symptoms, improving satisfaction with life and enhancing emotional regulation in adults with ADHD. |