Condition category
Mental and Behavioural Disorders
Date applied
26/07/2011
Date assigned
26/07/2011
Last edited
24/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.provide.ac.uk

Contact information

Type

Scientific

Primary contact

Mrs Gwen Brierley

ORCID ID

Contact details

Academic Unit of Primary Health Care
School of Social and Community Medicine
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
gwen.brierley@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10429

Study information

Scientific title

An individually randomised, parallel group controlled trial to determine if a psychological intervention delivered by domestic violence advocates is effective and cost-effective: Psychological Advocacy Towards Healing (PATH)

Acronym

PATH

Study hypothesis

The Psychological Advocacy Towards Healing (PATH) Study is an individually randomised two-arm controlled trial of a psychological intervention delivered by domestic violence advocates to women entering specialist domestic violence and abuse (DVA) services in Bristol and Cardiff respectively. Participants in the intervention arm will receive weekly specialist psychological advocacy sessions for 8 weeks and 2 reinforcement sessions over the subsequent 3 months. They will be followed up with questionnaires measuring violence, quality of life and mental health measures up to one year after recruitment.

Ethics approval

South West 4 approved on 08/03/2011 ref: REC 10/H0102/86

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: Mental Health

Intervention

Control Intervention: Routine care from domestic violence agency

Experimental Intervention: Routine care from domestic violence agency plus additional psychological support (8 one-to-one session with specialist psychological advocate plus two 'booster' sessions).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM); Timepoint(s): 4, 8 & 12 Months

Secondary outcome measures

1. Composite Abuse Scale (CAS); Timepoint(s): 4, 8, & 12 Months
2. EuroQoL EQ5D; Timepoint(s): 4, 8 & 12 Months
3. Generalised Anxiety Disorder (GAD-7); Timepoint(s): 4, 8 & 12 months
4. Patient Health Questionnaire (PHQ9); Timepoint(s): 4, 8 & 12 Months
5. Post-traumatic diagnositc scale (PDS); Timepoint(s): 4, 8 & 12 Months
6. Short form 12 (SF12); Timepoint(s): 4, 8 & 12 Months

Overall trial start date

28/03/2011

Overall trial end date

28/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Female, aged 16 years or older. Target Gender: Female ; Lower Age Limit 16 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 250; UK Sample Size: 250

Participant exclusion criteria

1. Psychotic illness
2. Unable to read English
3. Severe current drug or alcohol abuse
4. Currently attending counselling, cognitive beahviour therapy (CBT) or other psychological treatments either in primary care or specialist psychiatric services

Recruitment start date

28/03/2011

Recruitment end date

28/09/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Unit of Primary Health Care
Bristol
BS8 2PS
United Kingdom

Sponsor information

Organisation

University of Bristol (uk)

Sponsor details

School of Social and Community Medicine
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (Grant Codes: RP-PG-0108-10084)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23866771

Publication citations

  1. Protocol

    Brierley G, Agnew-Davies R, Bailey J, Evans M, Fackrell M, Ferrari G, Hollinghurst S, Howard L, Howarth E, Malpass A, Metters C, Peters TJ, Saeed F, Sardhina L, Sharp D, Feder GS, Psychological advocacy toward healing (PATH): study protocol for a randomized controlled trial., Trials, 2013, 14, 221, doi: 10.1186/1745-6215-14-221.

Additional files

Editorial Notes