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临床试验/CTRI/2025/12/099817
CTRI/2025/12/099817尚未招募不适用

Effect of cognitive behavioral therapy based occupational therapy program to reduce severity of suicidal ideation in patients with history of self-harm: a pilot study.

Seth GS medical college and KEM hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年1月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1

研究概览

简要总结

Title

Effect of cognitive behavioral therapy based occupational therapy program to reduce

severity of suicidal ideation in patients with history of self-harm: a pilot study.

Aim To reduce severity of suicidal ideation in patients attempting suicide.

Objectives

To measure pre and post intervention suicidal ideation by using modified scale of

suicidal ideation.

To implement CBT based OT program tailored to individual need.

Study Design:

Pre-test-post-test single group pilot study

Sampling technique: Convenience sampling

Sample size 20

Study setting The study will be conducted in Occupational therapy sections of psychiatry

KEMH in Mumbai.

Inclusion criteria:

Age  18years-60 years

Gender-Male and female

Patients referred from psychiatry department with history of self-harm or suicidal

ideation

Patients with MMSE score more than 23.

Exclusion criteria:

Patients with schizophrenia

Dementia

Head injury

Cerebrovascular accidents

ID

Autism

Postpartum psychosis

Terminal illness patients

Patient under hospice care

Patients with cognitive impairment.

Methodology

Approval will be taken from Institutional ethics committee (IEC).

Patients with history of self-harm or suicidal ideation referred from psychiatric

department will be enrolled in the study.

20 subjects /patients need to be recruited in the present study.

Patient will be explain about purpose and nature of study. Consent will be taken from

participant.

Screening for the cognitive functioning of the participant will be carried out by

administering Mini Mental State Examination more than 24 as per inclusion criteria

they would be included in the study.

Information about participant including demographics and MMSE score will be noted

on record form.

Modified scale of Suicidal Ideation (MSSI) will be administered to assess severity of

suicidal ideation. Score will be recorded pre and post intervention assessment on case

record form.

Participant will receive individualized CBT based OT intervention program for to

reducing the severity of suicidal ideation.

Duration –Cognitive behavioral therapy based occupational therapy program will be

given through 12 sessions in 6 weeks. The total days of therapy given will be 12 days

in a period of 6 weeks.

Sessions will be conducted twice in a week, with a 2 to 3 day interval between consecutive

therapy sessions.

Initial phase –It includes session 1 2 and 3 conducted per day on 3 different days over a

period of 1.5 weeks.

Middle phase –It includes session 4 5 6 7 8 and 9 conducted per day on 6 different days

over a period of 3 weeks.

Termination phase-It includes session 10 11 and 12 conducted per day on 3 different

days over a period of 1.5 weeks.

Each therapy session will last for 45 min.

Participant will be re-evaluated on MSSI after 6 weeks of intervention protocol.

Scores of both pre and post intervention assessment will be compared after completion

of intervention duration. Data collected, statistical analysis would be done using

appropriate statistical test and result will be derived.

If the participant undergoes ECT therapy on a scheduled CBT based OT session day,

the program session will be rescheduled for the next day.

If any situation arises during the study that requires psychiatric attention, the participant

will be immediately referred to a psychiatric department for appropriate management.

Study protocol:

Occupational therapy intervention would be tailored made for each patient using CBT based

OT program.

Occupational therapy intervention is based on 3 variables:

a) Therapeutic use of self

b) Activity engagement

c) Environmental modification.

Intervention consist of 3 phases:

  1. Initial phase
  2. Middle phase
  3. Termination phase Initial phase [session 1-3] –includes 5 components a) Chain analysis b) Psychoeducation c) Safety planning d) Developing reason for living and hope e) Case conceptualization Middle phase [session 4-9] Individual (includes behavioral activation and increasing pleasurable activities mood monitoring, emotion regulation and distress tolerance techniques, cognitive restructuring, problem solving, goal setting, mobilizing social support, and assertiveness skills) Family (include family behavioral activation, family emotion regulation, family problem solving, family communication, and family cognitive restructuring) skills training modules. The termination phase [session 10-12]-includes five steps (a) Preparation (b) Review of the indexed attempt or suicidal crisis (c) Review of the attempt or suicidal crisis using skills (d) Review of a future high risk scenario (e) Debriefing and follow-up. Statistical analysis Demographic data will be summarized using descriptive statistics. Continuous data will be represented as mean (Standard deviation) or Median (IQR). Categorical data will be summarized using frequency and percentage. McNemar test will be used to analyze paired categorical data. A 2-tailed P < 0.05 will be considered to be statistically significant. Statistical analysis will be performed by appropriate statistical tests using IBM SPSS v26 (statistical package for social sciences) software. Study tools: a) Mini Mental Status Examination -MMSE b) Modified scale of Suicidal ideation-MSSI

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients referred from psychiatry department with history of self-harm or suicidal ideation Patients with MMSE score more than 23.

排除标准

  • Patients with schizophrenia Dementia Head injury Cerebrovascular accidents Intellectual disability Autism Postpartum psychosis Terminal illness patients Patient under hospice care Patients with cognitive impairment.

研究者

发起方
Seth GS medical college and KEM hospital
申办方类型
Other [na]
责任方
Principal Investigator
主要研究者

DR SUSHANT SARANG

OCCUPATIONAL THERAPY TRAINING SCHOOL AND CENTRE,SETH G.S. MEDICAL COLLEGE AND KEM HOSPITAL

研究点 (1)

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