Self Harm in Females of South Asian Family Origin

NCT00884078 | Unknown

• 1 other identifier: 08/H1013/6
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Self Harm; Suicidal Idealtion; Hopelessness

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Suicidal Ideation (Beck scale for suicidal ideation)

  6 months

• Hopelessness (Beck hopelessness scale)

  6 months

• Time to self-reported repetition of self harm (estimate for RCT)

  6 months

Secondary Outcomes (1)

• Depressive symptoms assessed by Beck Depression Inventory

  6 months

Study Arms (2)

1

EXPERIMENTAL

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

2 Control group

NO INTERVENTION

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.

Interventions

Culturally adapted manualized problem solving training OTHER

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.

1

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lancashire Care NHS Foundation Trust: lead

Study Sites (3)

Manchester Royal Infirmary

Manchester, Greater Manchester, M13 9WL, United Kingdom

Location

North Manchester General Hospital

Manchester, Greater Manchester, M8 5RB, United Kingdom

Location

Royal Blackburn Hospital

Blackburn, Lancashire, BB2 3HH, United Kingdom

Location

MeSH Terms

Conditions

Self-Injurious Behavior; Depression; Suicidal Ideation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide

Study Officials

• Nusrat Husain, Consultant Psychiatrist

  LCFT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nusrat Husain

CONTACT

00441772 773502; nusrat.husain@manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: April 20, 2009
• Study Start: May 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 20, 2009

Record last verified: 2009-04

Locations

GB (3)