NCT01054898

Brief Summary

The purpose of this study is to determine if a telephone social support and empowerment intervention is more effective than usual community services in improving the mental health of community-dwelling women abused by their intimate partners.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

January 20, 2010

Last Update Submit

May 26, 2015

Conditions

Keywords

depressionspouse abuseintervention studies

Outcome Measures

Primary Outcomes (1)

  • depression

    On completion of intervention and six months post-intervention

Secondary Outcomes (5)

  • perceived social support

    On completion of intervention and six months post-intervention

  • health-related quality of life

    On completion of intervention and six months post-intervention

  • intimate partner violence

    On completion of intervention and six months post-intervention

  • safety behaviors

    On completion of intervention and six months post-intervention

  • utilization of health services

    On completion of intervention and six months post-intervention

Study Arms (2)

advocacy intervention

EXPERIMENTAL

A 12-week telephone social support and empowerment intervention consisting of empowerment training, scheduled weekly telephone calls, and 24-hour access to a hotline for abused women

Behavioral: advocacy intervention

Usual community services

ACTIVE COMPARATOR

Standard care for abused women in the community

Behavioral: usual community services

Interventions

A 12-week telephone social support and empowerment intervention consisting of empowerment training, scheduled weekly telephone calls, and 24-hour access to a hotline for abused women

advocacy intervention

standard care for abused women in the community

Usual community services

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chinese women 18 years of age or older
  • Self-report of psychological, physical or sexual abuse by their current or former intimate partner in the previous 12 months
  • Live or work in a community within the catchment area of a community centre designated for the proposed study

You may not qualify if:

  • Perpetrator is not an intimate partner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong SKH Lady MacLehose Centre

Hong Kong, Hong Kong, China

Location

Related Publications (2)

  • Tiwari A, Fong DY, Wong JY, Yuen KH, Yuk H, Pang P, Humphreys J, Bullock L. Safety-promoting behaviors of community-dwelling abused Chinese women after an advocacy intervention: a randomized controlled trial. Int J Nurs Stud. 2012 Jun;49(6):645-55. doi: 10.1016/j.ijnurstu.2011.12.005. Epub 2012 Jan 9.

  • Tiwari A, Fong DY, Yuen KH, Yuk H, Pang P, Humphreys J, Bullock L. Effect of an advocacy intervention on mental health in Chinese women survivors of intimate partner violence: a randomized controlled trial. JAMA. 2010 Aug 4;304(5):536-43. doi: 10.1001/jama.2010.1052.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Agnes Tiwari, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head

Study Record Dates

First Submitted

January 20, 2010

First Posted

January 22, 2010

Study Start

February 1, 2007

Primary Completion

December 1, 2008

Study Completion

June 1, 2009

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations