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CTRI Number  CTRI/2022/04/042090 [Registered on: 22/04/2022] Trial Registered Prospectively
Last Modified On: 21/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Assessing the outcomes of using Brief Cognitive Therapy for Individuals with Suicidal thoughts and behaviours seeking psychiatric care.  
Scientific Title of Study   Brief Cognitive Therapy for Individuals with Suicidal Risk Attending Psychiatric Services: A Preliminary Outcome Study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swarnalakshmi S 
Designation  Ph D Scholar 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Hosur road

Bangalore
KARNATAKA
560029
India 
Phone  9789990628  
Fax    
Email  swarna.nimhans@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M Manjula 
Designation  Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Hosur road

Bangalore
KARNATAKA
560029
India 
Phone  08026995182  
Fax    
Email  drmanjula71@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Swarnalakshmi S 
Designation  Ph D Scholar 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Hosur road

Bangalore
KARNATAKA
560029
India 
Phone  9789990628  
Fax    
Email  swarna.nimhans@gmail.com  
 
Source of Monetary or Material Support  
UGC JRF Scholarship 343/(OBC)(NET-JAN2017) University Grants Commission (UGC)Bahadur Shah Zafar Marg New Delhi 110002  
 
Primary Sponsor  
Name  Swarnalakshmi S 
Address  Ph D Scholar, Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Hosur road 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Swarnalakshmi S  National Institute of Mental Health and Neurosciences  Behavioural Medicine Unit, Department of Clinical Psychology, Basement, M. V. Govindaswamy building, National Institute of Mental Health and Neurosciences, Hosur road, Bengaluru, Karnataka-560029
Bangalore
KARNATAKA 
9789990628

swarna.nimhans@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Mental Health and Neurosciences Institutional Ethics Commitee (Behavioural Sciences division)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Intervention  Cognitive Therapy for Suicidal Patients (CT-SP)  CT-SP is a cognitive-behavioural treatment for adults with suicidal ideation and behaviours (Wenzel et al., 2009). It is a manualized and evidence-based 10-session treatment protocol based on a cognitive-behavioural model of suicidal thoughts and behaviours. The intervention includes three phases focused on risk assessment and safety planning, cognitive case conceptualization, application of cognitive and behavioural strategies and relapse prevention protocols that are planned to be carried out over 5 weeks.  
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  - Individuals with significant suicidal ideation or suicidal behaviours. A score of 3 or
above on the suicide ideation severity subscale of the C-SSRS indicating active
suicidal ideation in the past month and/or endorsement of any the suicidal behaviours
ranging from preparatory acts to suicide attempts in the C-SSRS Suicidal Behaviour
scale in the last 3 months will be considered as significant.
- Individuals in the age range of 18 - 60 years.
- Ability to read and write in English or Tamil.
 
 
ExclusionCriteria 
Details  - Individuals with diagnosis of schizophrenia, psychosis, bipolar affective disorder,
severe depression or obsessive-compulsive disorder whose symptom severity prevents
engagement in therapy based on clinical evaluation.
- Clinical history suggestive of mental retardation and other developmental disorders
including autism spectrum.
- Underwent Electro-convulsive therapy (ECT) in the last 15 days.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Severity of suicidal ideation and behaviours  1. Baseline
2. Post-Treatment
3. 1-month follow-up
4. 3-months follow-up
5. 6 months follow-up 
 
Secondary Outcome  
Outcome  TimePoints 
Hopelessness  1. Baseline
2. Post-Treatment
3. 3-months follow-up
4. 6 months follow-up 
Severity of depressive symptoms  1. Baseline
2. Post-Treatment
3. 3-months follow-up
4. 6 months follow-up 
Severity of anxiety symptoms  1. Baseline
2. Post-Treatment
3. 3-months follow-up
4. 6 months follow-up 
Difficulties in emotion regulation  1. Baseline
2. Post-Treatment
3. 3-months follow-up
4. 6 months follow-up 
Automatic thoughts  1. Baseline
2. Post-Treatment
3. 3-months follow-up
4. 6 months follow-up 
Cognitive control and flexibilty  1. Baseline
2. Post-Treatment
3. 3-months follow-up
4. 6 months follow-up 
Problem solving  1. Baseline
2. Post-Treatment
3. 3-months follow-up
4. 6 months follow-up 
General Functioning  1. Baseline
2. Post-Treatment
3. 1-month follow-up
4. 3-months follow-up
5. 6 months follow-up 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   25/04/2022 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Suicidal thoughts and behaviours (STBs) have high mortality rates, personal, social and economic costs which are compounded in the presence of mental health concerns. Despite the effectiveness of direct, suicide-focused interventions on STBs, there is an obvious lack in the research and implementation of such interventions in India; more so among those seeking psychiatric services. Hence, the present study intends to explore the effectiveness of an evidence based brief cognitive therapy intervention – Cognitive Therapy for Suicidal Patients in the management of STBs. 
The aim of the present study is to examine the effectiveness of Cognitive Therapy for Suicidal Patients (CT-SP) in reducing suicide risk for patients attending psychiatric services and experiencing STBs. 
An open label, single group with multiple assessment design will be adopted for the present study. The study will be conducted in two phases. The first would aim at examining the feasibility, acceptability and usefulness of the intervention, while the second is the main study. In the pilot phase, CT-SP will be administered on 5 patients with suicidal ideation and/or behaviours and the patients will be interviewed using an interview guide developed by the researcher. In the main phase, 50 individuals with STBs would be recruited from the inpatient and outpatient mental health services of National institute of Mental Health and Neurosciences based on specified inclusion and exclusion criteria. Recruited patients will be given 10 biweekly sessions of CT-SP. The assessments will be done using Columbia Suicide Severity Rating Scale (C-SSRS) (Screening and primary outcome measure), Beck Hopelessness Scale (BHS), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Scale (HAM-D), Difficulties in Emotion Regulation Scale (DERS), Automatic Thoughts Questionnaire (ATQ), Cognitive Control and Flexibility Questionnaire (CCFQ), Personal Problem-Solving Inventory (PPSI) and Global Assessment of Functioning (GAF). The assessments will be carried out at baseline, post-intervention, and at 1-, 3- and 6-month follow-ups. The participants engagement in other therapy after the intervention will be recorded at follow-ups. Data obtained in each of the phases will be recorded, analyzed and interpreted using suitable methods. Qualitative content analysis will be used to understand usefulness and helpful aspects of therapy during the pilot phase. The data obtained using the tools will be tabulated and subjected to statistical analysis using R Software. Descriptive statistics such as mean, standard deviation, frequency and proportion will be used to express the data. The association between the demographic variables and the outcome variables will be examined. Paired t-test or the analogous non-parametric test will be used to compare the overall mean values between the pre and post measurements. P value less than 0.05 will be considered as statistically significant. Repeated Measures ANOVA will be used to assess change across different time points. Pearson’s correlation coefficient or Spearman’s Rho will be used to measure relationship between variables. The subgroups of treatment engagement reported at post-intervention will also be examined using appropriate tests of association. During the study period, the participants will be monitored for increase in suicidal risk. SOP for such situations would be implemented with steps such as making psychiatric referrals and involvement of a designated contact person who would be informed on steps to be taken in emergencies
 
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