Psychological Advocacy Towards Healing (PATH): To determine if a psychological intervention delivered by domestic violence advocates is effective and cost-effective

ISRCTN	ISRCTN58561170
DOI	https://doi.org/10.1186/ISRCTN58561170
Protocol serial number	10429
Sponsor	University of Bristol (uk)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (Grant Codes: RP-PG-0108-10084)

Submission date: 26/07/2011
Registration date: 26/07/2011
Last edited: 28/11/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Gwen Brierley
Scientific

Academic Unit of Primary Health Care
School of Social and Community Medicine
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom

Email	gwen.brierley@bristol.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Treatment
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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)
Study acronym	PATH
Study objectives	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(s)	South West 4 approved on 08/03/2011 ref: REC 10/H0102/86
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM); Timepoint(s): 4, 8 & 12 Months
Key secondary outcome measure(s)	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
Completion date	28/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	250
Key inclusion criteria	Female, aged 16 years or older. Target Gender: Female ; Lower Age Limit 16 years
Key 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
Date of first enrolment	28/03/2011
Date of final enrolment	28/09/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Academic Unit of Primary Health Care

Bristol
BS8 2PS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	27/11/2018		Yes	No
Protocol article	protocol	17/07/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

28/11/2018: Publication reference added.
27/09/2018: Conference proceedings added to publication and dissemination plan.