| 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
|
|
|
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
|
|
|
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 |