NCT02742922

Brief Summary

To evaluate the clinical and cost-effectiveness of a culturally adapted therapy (C-MAP) in patients with a history of self-harm

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
901

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

April 27, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

3.3 years

First QC Date

February 19, 2016

Last Update Submit

May 18, 2023

Conditions

Self Harm

Keywords

self harmculturally adapted therapyproblem solving therapylow and middle income countries

Outcome Measures

Primary Outcomes (1)

  • Suicide Attempt Self Injury Interview SASII

    Repetition rate of self-harm measured by adapted Suicide Attempt Self-Injury Interview (SASII)

    up to 12th months

Secondary Outcomes (6)

  • Beck Scale for Suicidal ideation (BSI).

    Baseline, 3, 6, 9 and 12th months

  • Beck Hopelessness Scale

    Baseline,3rd,6th,9th and 12th months

  • Beck Depression Inventory (BDI)

    Baseline,3rd,6th,9th and 12th months

  • EuroQol-5 Dimensions (EQ5-D)

    Baseline,3rd,6th,9th and 12th months

  • Coping Resource Inventory (CRI).

    Baseline,3rd,6th,9th and 12th months

  • +1 more secondary outcomes

Study Arms (2)

Culturally adapted therapy (C-MAP)

EXPERIMENTAL

Culturally adapted manual assisted (C-MAP) brief problem solving therapy

Behavioral: Culturally adapted therapy (C-MAP)

Treatment as usual

NO INTERVENTION

This arm will receive no intervention only TAٓU.

Interventions

Culturally adapted therapy (C-MAP)BEHAVIORAL

C-MAP is a brief problem focused therapy, comprising of six sessions delivered within three months. C-MAP is a manual assisted intervention based on the principles of CBT .In this intervention there is an evaluation of the self-harm attempt, crisis skills, problem solving and basic cognitive techniques to manage emotions, negative thinking and relapse prevention strategies.

Also known as: psycho social intervention
Culturally adapted therapy (C-MAP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over the age of 18 years will be considered eligible for the study.
  • Participants will have to be living within the catchment area of the participating practices and hospitals.
  • Not needing inpatient psychiatric treatment.

You may not qualify if:

  • Temporary resident unlikely to be available for follow up.
  • Participants with ICD-I0 mental disorder; due to a general medical condition or substance misuse, dementia, delirium, alcohol or drug dependence, schizophrenia, bipolar disorder, learning disability.
  • Unable to engage, participate or respond to the research questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Bolan Medical Complex

Quetta, Balochistan, Pakistan

Location

Khyber Teaching Hospital

Peshawar, KPK, Pakistan

Location

Jinah Hospital

Lahore, Punjab Province, Pakistan

Location

Services Hospital

Lahore, Punjab Province, Pakistan

Location

Rawalpindi General Hospital

Rawalpindi, Punjab Province, Pakistan

Location

Civil Hospital

Karachi, Sindh, 72400, Pakistan

Location

Abbasi Hospital

Karachi, Sindh, Pakistan

Location

Related Publications (2)

  • Husain N, Kiran T, Chaudhry IB, Williams C, Emsley R, Arshad U, Ansari MA, Bassett P, Bee P, Bhatia MR, Chew-Graham C, Husain MO, Irfan M, Khaliq A, Minhas FA, Naeem F, Naqvi H, Nizami AT, Noureen A, Panagioti M, Rasool G, Saeed S, Bukhari SQ, Tofique S, Zadeh ZF, Zafar SN, Chaudhry N. A culturally adapted manual-assisted problem-solving intervention (CMAP) for adults with a history of self-harm: a multi-centre randomised controlled trial. BMC Med. 2023 Jul 31;21(1):282. doi: 10.1186/s12916-023-02983-8.

    PMID: 37525207DERIVED

  • Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

    PMID: 33884617DERIVED

Related Links

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Nusrat Husian, MD

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Investigator

Study Record Dates

First Submitted

February 19, 2016

First Posted

April 19, 2016

Study Start

April 27, 2016

Primary Completion

July 30, 2019

Study Completion

October 30, 2019

Last Updated

May 19, 2023

Record last verified: 2023-05

Locations

PA(7)