| CTRI Number |
CTRI/2025/03/083631 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Integrative Psychotherapy for Substance Use Disorders with Antisocial Behavior |
|
Scientific Title of Study
|
Application of Integrative Psychotherapy on Emotional
Dysregulation, Self-Serving Cognitive Distortions, Executive Dysfunction among Patients of Substance Use Disorders with Antisocial Behavior: A Randomized Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jasar Khan |
| Designation |
PhD Scholar |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Department of Clinical Psychology, Central Institute of Psychiatry, Kanke, Ranchi
Ranchi
JHARKHAND
834006
India |
| Phone |
7011326859 |
| Fax |
|
| Email |
psy.jasar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjay Kumar Munda |
| Designation |
Professor of Psychiatry |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Department of Psychiatry, Central Institute of Psychiatry, Kanke Ranchi
Ranchi
JHARKHAND
834006
India |
| Phone |
8797641082 |
| Fax |
|
| Email |
drsanjaymunda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Masroor Jahan |
| Designation |
Additional Professor |
| Affiliation |
Ranchi Institute of Neuro-Psychiatry and Allied Sciences |
| Address |
Department of Clinical Psychology, Ranchi Institute of Neuro-Psychiatry and Allied Sciences, Ranchi
Ranchi
JHARKHAND
834006
India |
| Phone |
7903413032 |
| Fax |
|
| Email |
masroorjahan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand, India 834006 |
|
|
Primary Sponsor
|
| Name |
Jasar Khan |
| Address |
Department of Clinical Psychology, Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand, India 834006 |
| 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 |
| Jasar Khan |
SS Raju Centre for Addiction Psychiatry, Central Institute of Psychiatry, Ranchi, 834006 |
Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand, India 834006
Ranchi
JHARKHAND |
7011326859
psy.jasar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, Central Institute of Psychiatry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, (2) ICD-10 Condition: F122||Cannabis dependence, (3) ICD-10 Condition: F142||Cocaine dependence, (4) ICD-10 Condition: F162||Hallucinogen dependence, (5) ICD-10 Condition: F182||Inhalant dependence, (6) ICD-10 Condition: F172||Nicotine dependence, (7) ICD-10 Condition: F112||Opioid dependence, (8) ICD-10 Condition: F192||Other psychoactive substance dependence, (9) ICD-10 Condition: F152||Other stimulant dependence, (10) ICD-10 Condition: F132||Sedative, hypnotic or anxiolytic-related dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrative Psychotherapy |
18 session over 6 weeks including Psychoeducation, Motivational Interviewing, Enhancing Frustration and Distress Tolerance, Emotion Regulation skills, Attachment & Mentalization based treatment, The Internal Family System (IFS),Drama Triangle, Cognitive therapy, Impulsive Lifestyle Counselling (ILC), Social Problem solving - Stop & Think, Relapse Prevention, Positive Psychology Interventions |
| Comparator Agent |
Treatment as Usual |
Motivational Enhancement Therapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Male |
| Details |
1. Participants diagnosed using ICD 10 DCR 56 with Mental and Behavioural disorders due to use of alcohol dependence syndrome (F10.2), Opioid Dependence syndrome (F11.2) cannabinoids dependence syndrome (F12.2), sedatives or hypnotics, dependence syndrome. (F13.2), volatile solvents, dependence syndrome. (F18.2), multiple drug use and use of other psychoactive substances, dependence syndrome. (F19.2).
2. Participants with an overall PCL-R score of 20 and above.
3. Age range of 18-35 years of age.
4. Male Gender
5. Participants with at least a secondary level of education.
6. Participants who are fluent in Hindi or English language
7. Participants who consent to the research study |
|
| ExclusionCriteria |
| Details |
1. Participants with a history of traumatic brain injury, intellectual disability or
any neurological condition, organic brain disease, and epilepsy.
2. Participants with only Nicotine Dependence.
3. Participants with impairment of hearing, vision, physical or other forms of
disability.
4. Participants with major functional mental illnesses (i.e., schizophrenia,
schizoaffective disorder, and bipolar disorder) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difficulties in regulating emotions, Self-serving cognitive distortions and executive dysfunction |
Baseline, post intervention and two months follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Craving, Readiness to change and Locus of control |
Baseline, Post Intervention, and two months follow-up |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
08/04/2025 |
| 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
|
Present study seeks to investigates the role of emotional dysregulation, self-serving cognitive distortions and executive dysfunction in patients with substance use disorders (SUDs) with antisocial behaviors in a tertiary inpatient setting. Given the high prevalence of antisocial personality traits in this population and their link to poor treatment outcomes, the study compares the effectiveness of Integrative Psychotherapy combined with pharmacotherapy against standard treatment (Motivational Enhancement Therapy and pharmacotherapy). Forty male participants aged 18–35 will be randomly assigned to either group, with assessments conducted at baseline, post-intervention, and two-month follow-up. Primary outcomes include emotional regulation, executive function, and cognitive distortions, while secondary outcomes assess craving, readiness to change, and locus of control. The study aims to enhance rehabilitation outcomes by addressing underlying cognitive and emotional dysfunctions often overlooked in conventional treatments. |