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
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
-
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.