Self Harm in Females of South Asian Family Origin

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2009 by Lancashire Care NHS Foundation Trust.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Lancashire Care NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT00884078

First received: February 19, 2009

Last updated: April 17, 2009

Last verified: April 2009

History of Changes

Purpose

Aim of the study is to adapt and develop a culturally appropriate psychological intervention and to pilot test it's feasibility, and acceptability for the adult South Asian females presenting to general hospital emergency department following self-harm. Primary hypothesis for the study is to determine whether a brief psychological intervention compared with treatment as usual for self-harm results in decreased hopelessness and suicidal ideation. Further to this to collect necessary information on recruitment, the assessment instruments, effect size, the optimal delivery and acceptability of the intervention in preparation for a definitive RCT using repetition of self harm and cost effectiveness as the primary outcome measures.

Condition	Intervention
Self Harm Suicidal Idealtion Hopelessness	Other: Culturally adapted manualized problem solving training

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Exploratory RCT of Culturally Adapted Manual Assisted Problem Solving Training (C-MAP) for Self Harm in Females of South Asian Family Origin

Resource links provided by NLM:

MedlinePlus related topics: Depression Suicide

U.S. FDA Resources

Further study details as provided by Lancashire Care NHS Foundation Trust:

Primary Outcome Measures:

Suicidal Ideation (Beck scale for suicidal ideation) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Hopelessness (Beck hopelessness scale) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Time to self-reported repetition of self harm (estimate for RCT) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Depressive symptoms assessed by Beck Depression Inventory [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	May 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 C-MAPS (Culturally adapted manualized problem solving training) will be a brief problem focused therapy comprising of 8 sessions within three months after a self-harm episode. We will have two engagement sessions before the actual therapy. The adapted therapy/training will be delivered by therapists/trained counselors in the patient's home/GP practice depending upon patient's choice. Sessions will be offered weekly in the first month and than fortnightly and will last 50 minutes.	Other: Culturally adapted manualized problem solving training The areas covered by the manual include an evaluation of the self-harm attempt, crisis skills, problem solving, and basic cognitive techniques to manage emotions and negative thinking and relapse prevention strategies. The treatment will be structured around patient's current problems with the relevant sections of the manual helping the patient to deal with specific problems leading to the self-harm act. Between the sessions the manual can be used for homework tasks by the patient. We will be able to linguistically match the therapist and the participant in three most common languages spoken and understood in South Asian population i.e. Urdu, Hindi and Punjabi.
No Intervention: 2 Control group Patients who will be randomized to the "treatment as usual" arm will receive routine care. In most cases this consists of an assessment by a casualty doctor or a junior psychiatrist in the emergency department, on the basis of which about one third patients are referred for follow up as a psychiatry outpatient, a small number are referred to addiction services, and the remainder are advised to consult their own general practitioner (Kapur 1998) this is particularly so in case of Asian females (Cooper et al, 2006). No patients are routinely referred to psychotherapy or psychology services. Participants will receive an initial assessment along with treatment as usual (TAU) as ascertained by the general practitioner or mental health professional any type of treatment apart from C-MAPS will be permitted. We will record the degree of patient adherence to standard care.

Arms

Assigned Interventions

Experimental: 1

C-MAPS (Culturally adapted manualized problem solving training) will be a brief problem focused therapy comprising of 8 sessions within three months after a self-harm episode. We will have two engagement sessions before the actual therapy. The adapted therapy/training will be delivered by therapists/trained counselors in the patient's home/GP practice depending upon patient's choice. Sessions will be offered weekly in the first month and than fortnightly and will last 50 minutes.

Other: Culturally adapted manualized problem solving training

The areas covered by the manual include an evaluation of the self-harm attempt, crisis skills, problem solving, and basic cognitive techniques to manage emotions and negative thinking and relapse prevention strategies. The treatment will be structured around patient's current problems with the relevant sections of the manual helping the patient to deal with specific problems leading to the self-harm act. Between the sessions the manual can be used for homework tasks by the patient. We will be able to linguistically match the therapist and the participant in three most common languages spoken and understood in South Asian population i.e. Urdu, Hindi and Punjabi.

No Intervention: 2 Control group

Patients who will be randomized to the "treatment as usual" arm will receive routine care. In most cases this consists of an assessment by a casualty doctor or a junior psychiatrist in the emergency department, on the basis of which about one third patients are referred for follow up as a psychiatry outpatient, a small number are referred to addiction services, and the remainder are advised to consult their own general practitioner (Kapur 1998) this is particularly so in case of Asian females (Cooper et al, 2006). No patients are routinely referred to psychotherapy or psychology services. Participants will receive an initial assessment along with treatment as usual (TAU) as ascertained by the general practitioner or mental health professional any type of treatment apart from C-MAPS will be permitted. We will record the degree of patient adherence to standard care.

Show Detailed Description

Eligibility

Ages Eligible for Study:	16 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All females of self ascribe south Asian family origin presenting to an emergency department of the proposed study centers after an episode of self-harm.

By self harm we mean self inflicted injury, and/or ingestion of drugs in excess of the recommended therapeutic dose, with some intention of ending one's life (Vajda and Steinbeck 2000).
Age: 16 - 65 years
Resident in the trial site catchment area

Exclusion Criteria:

Participants will not be excluded based on limited knowledge of English.

Temporary resident unlikely to be available for follow up.
ICD 10 diagnosis organic (F.0), of alcohol and drug dependence (F.1x.2) Schizophrenia (F.2) or Bipolar Affective Disorder (F.31) because these patients require a different treatment approach.
Psychiatric admission required after deliberate self-harm.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884078

Contacts

Contact: Nusrat Husain

00441772 773502

nusrat.husain@manchester.ac.uk

Locations

United Kingdom
North Manchester General Hospital	Not yet recruiting
Manchester, Greater Manchester, United Kingdom, M8 5RB
Contact: Nasim Chaudhry, Consultant Psychiatrist nasimchaudhry@btinternet.com
Principal Investigator: Nasim Chaudhry, Consultant Psychiatrist
Manchester Royal Infirmary	Not yet recruiting
Manchester, Greater Manchester, United Kingdom, M13 9WL
Contact: Nusrat Husain, Consultant Psychiatrist 004401772 773502 nusrat.husain@manchester.ac.uk
Sub-Investigator: Stewart Duriraj, Registrar
Sub-Investigator: Kalyani Kodimela, Registrar
Royal Blackburn Hospital	Not yet recruiting
Blackburn, Lancashire, United Kingdom, BB2 3HH
Contact: Nusrat Husain, Consultant Psychiatrist 00441772 773502 nusrat.husain@manchester.ac.uk
Contact: Diwakar Nagaraj, Registrar 00441254 226253 drdiwakarnagaraj@gmail.com
Principal Investigator: Nusrat Husain, Consultant Psychiatrist
Sub-Investigator: Diwakar Nagaraj, Registrar
Sub-Investigator: Sarrah Khan, Research assistant

Sponsors and Collaborators

Lancashire Care NHS Foundation Trust

Investigators

Principal Investigator:

Nusrat Husain, Consultant Psychiatrist

LCFT

More Information

No publications provided

Responsible Party:	Louise Worrell, LCFT
ClinicalTrials.gov Identifier:	NCT00884078 History of Changes
Other Study ID Numbers:	08/H1013/6
Study First Received:	February 19, 2009
Last Updated:	April 17, 2009
Health Authority:	United Kingdom:Tameside & Glossip local research ethics committee. United Kingdom:Lancashirecare Foundation Trust

Keywords provided by Lancashire Care NHS Foundation Trust:

Self harm in south asian women
depression
suicidal ideations
problem solving training

ClinicalTrials.gov processed this record on May 19, 2013

To Top