| CTRI Number |
CTRI/2024/02/062422 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Psychological ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Psychotherapy for individuals with psychological trauma and substance use disorders.
|
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Scientific Title of Study
|
Development and feasibility Integrated trauma-focused psychotherapy for substance use disorders- role of identity and meaning making. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nishita Choudhari |
| Designation |
PhD scholar |
| Affiliation |
National Institute of Mental Health and NeuroSciences (NIMHANS) |
| Address |
Department of clinical psychology, Dr.M.V.Govindaswamy building, National Institute of Mental Health and NeuroSciences (NIMHANS)
Bangalore
KARNATAKA
560029
India |
| Phone |
9920062583 |
| Fax |
|
| Email |
nishitachoudharii@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Gitanjali Narayanan |
| Designation |
Additional Professor of Clinical Psychology |
| Affiliation |
National Institute of Mental Health and NeuroSciences (NIMHANS) |
| Address |
Department of clinical psychology, Dr.M.V.Govindaswamy building, National Institute of Mental Health and NeuroSciences (NIMHANS)
Bangalore
KARNATAKA
560029
India |
| Phone |
9650137619 |
| Fax |
|
| Email |
gitanjali_n@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nishita Choudhari |
| Designation |
PhD scholar |
| Affiliation |
National Institute of Mental Health and NeuroSciences (NIMHANS) |
| Address |
Department of clinical psychology, Dr.M.V.Govindaswamy building, National Institute of Mental Health and NeuroSciences (NIMHANS)
KARNATAKA
560029
India |
| Phone |
9920062583 |
| Fax |
|
| Email |
nishitachoudharii@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institue stipendary- Department of Clinical Psychology, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore. |
|
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Primary Sponsor
|
| Name |
National Institute of Mental Health and NeuroSciences (NIMHANS) |
| Address |
National Institute of Mental Health and NeuroSciences (NIMHANS), Bengaluru |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrJayant Mahadevan |
National Institute of Mental Health and NeuroSciences (NIMHANS) |
Room no. G14, Clinical Psychologist room, De-addiction Centre,National Institute of Mental Health and NeuroSciences (NIMHANS), Bengaluru
Bangalore
KARNATAKA |
9894162384
jayantmahadevan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Commitee- Behavioral Sciences Division |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Trauma focused psychotherapy for substance use disorders. |
psychotherapy sessions focusing on substance use disorders, psychological trauma, meaning-making and identity processes.
Duration of the intervention- 18 psychotherapy sessions- 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals with a file diagnosis Substance Use Disorders, as per DSM-5 diagnostic criteria.
2. Individuals who have been screened for past or current exposure to trauma.
3. 9th grade (high school) reading level for English. |
|
| ExclusionCriteria |
| Details |
1. Individuals under acute intoxication or continuing to have severe withdrawal symptoms.
2. Individuals diagnosed with severe mental health disorders like severe depression, current manic episode, severe suicidal risk and active psychotic symptoms.
3. Individuals diagnosed with Intellectual and developmental disabilities as per file diagnosis.
4. Individuals with frontal lobe syndromes, peripheral neuropathy or any other neurological conditions (as per file diagnosis) that prevents patients from engaging in therapy.
5. Individuals who have undergone structured psychotherapy for more than 8 or more sessions in the past 6 months.
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
1.Substance use related outcomes: Quantity, frequency, duration and severity of substance use.
2.Trauma related outcomes:
i.Trauma response
ii.Meaning- Making and Post-traumatic Growth.
3. Changes in Identity functioning
4. Change Mechanisms- Therapeutic alliance and helpful aspects of therapy.
5.General outcome measures- Emotion regulation and Quality of Life.
|
1. Pre-intervention
2. Post-intervention
3. One-month follow up
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "21"
Final Enrollment numbers achieved (India)="21" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/02/2024 |
| Date of Study Completion (India) |
29/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nishitachoudharii@gmail.com].
- For how long will this data be available start date provided 20-12-2024 and end date provided 20-12-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
The present study aims to develop and test the feasibility of an Integrated Trauma-Focused Psychotherapy for individuals with Substance Use Disorders (ITFP-SUD). It further attempts to explore the role of identity and meaning making processes within this integrated psychotherapy. The objectives of the study include developing the therapy module, testing the effectiveness of the ITFP-SUD on 21 participants in terms of substance use outcomes, trauma-related outcomes (trauma symptoms), meaning making, post-traumatic growth, identity functioning, emotion regulation, quality of life, treatment effectiveness, alongside process factors (Therapeutic Alliance and helpful events in therapy). A mixed-methods design is used, and a single-group pre-post-follow-up design is adopted for the limited efficacy testing of the ITFP-SUD. Purposive sampling will be used to recruit clients from the Center for Addiction Medicine and Adult Psychiatry Units, NIMHANS, Bengaluru, who meet the inclusion and exclusion criteria and provide informed consent. The study will be conducted in two phases. The therapy guide has been developed in Phase I based on a detailed needs assessment comprising 4 arms (in-depth patient interviews, two focus-group discussions, administration of quantitative assessment measures on patients, and a review of literature). Based on this data, a total of 20-25 sessions over 2-3 months have been finalized. Expert validation of the therapy guide and feasibility assessment have been completed, and the therapy outline is provided below. The sample size (22 participants) has been calculated for a single-group, repeated-measures, within-factors design with 3 observations. Assuming a moderate effect size of .40 (based on previous literature), an alpha error of .01 (accounting for multiple testing correction), and a power of 80%. Analysis will be planned using descriptive measures, repeated measures ANOVA/Friedman’s test, and qualitative analysis. The ethical considerations have been adhered to, keeping in mind the guidelines for conducting research in the field of trauma and substance use disorders. ITFP-SUD outline:
Sr.No | Name of the phase/module | Targets | Number of sessions | 1 | Recruitment and assessment | Informed consent and administering assessments | 2-3 | 2 | PHASE I- Safety and Stabilization | Ensuring safety, psychoeducation and socializing the patient into treatment | 2-5 | 3. | Phase II- Resource building | 6-9 | | A. Regulating Substance use | Reduction/ abstinence from substance use |
| | B. Optimizing emotional and interpersonal resources | Regulating emotions Interpersonal skills |
| 4 | Phase III- Trauma and abuse | 6-9 | | Exploring trauma narratives- processing and integration | Exposure for traumatic memories | | | Making meaning and looking ahead | Meaning making, positive psychological growth post trauma | | 5 | Termination | Terminating therapy and assessments | 2-3 | | ELECTIVES | 1 | Managing suicidal thoughts and behaviors | Suicidal ideation, suicide attempts | As many as required | 2 | Self-care | Sleep hygiene, regular meal times, structure in daily routine | 3-5 | 3 | Building a network of support- Family and Significant others | Psychoeducation for family members/ significant others; eliciting support from family members/ significant others | 2-5 | 4 | Enhancing motivation. | Motivation enhancement for substance use | As many as required |
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