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Psychological Advocacy Towards Healing (PATH): To determine if a psychological intervention delivered by domestic violence advocates is effective and cost-effective
ISRCTN ISRCTN58561170
DOI 10.1186/ISRCTN58561170
ClinicalTrials.gov identifier
EudraCT number
Public title Psychological Advocacy Towards Healing (PATH): To determine if a psychological intervention delivered by domestic violence advocates is effective and cost-effective
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
Serial number at source 10429
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.
Lay summary Not provided at time of registration
Ethics approval South West 4 approved on 08/03/2011 ref: REC 10/H0102/86
Study design Randomised; Interventional; Design type: Treatment
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: Mental Health
Participants - inclusion criteria Female, aged 16 years or older. Target Gender: Female ; Lower Age Limit 16 years
Participants - 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
Anticipated start date 28/03/2011
Anticipated end date 28/09/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Planned Sample Size: 250; UK Sample Size: 250
Interventions 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).
Primary outcome measure(s) Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM); Timepoint(s): 4, 8 & 12 Months
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
Sources of funding National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (Grant Codes: RP-PG-0108-10084)
Trial website http://www.provide.ac.uk
Publications 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23866771
Contact name Mrs  Gwen  Brierley
  Address Academic Unit of Primary Health Care
School of Social and Community Medicine
Canynge Hall
39 Whatley Road
  City/town Bristol
  Zip/Postcode BS8 2PS
  Country United Kingdom
  Email gwen.brierley@bristol.ac.uk
Sponsor University of Bristol (uk)
  Address School of Social and Community Medicine
Canynge Hall
39 Whatley Road
  City/town Bristol
  Zip/Postcode BS8 2PS
  Country United Kingdom
Date applied 26/07/2011
Last edited 24/07/2013
Date ISRCTN assigned 26/07/2011
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