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Register:	ISRCTN
Last refreshed on:	14 January 2019
Main ID:	ISRCTN58561170
Date of registration:	26/07/2011
Prospective Registration:	No
Primary sponsor:	University of Bristol (uk)
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)
Date of first enrolment:	28/03/2011
Target sample size:	250
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN58561170
Study type:	Interventional
Study design:	Randomised; Interventional; Design type: Treatment (Treatment)
Phase:	Not Applicable

Countries of recruitment
United Kingdom

Contacts

Name:	Gwen Brierley
Address:	Academic Unit of Primary Health Care School of Social and Community Medicine Canynge Hall 39 Whatley Road BS8 2PS Bristol United Kingdom
Telephone:	-
Email:	gwen.brierley@bristol.ac.uk
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: Mental Health
Mental and Behavioural Disorders
Domestic violence and abuse

Intervention(s)

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(s)

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

Secondary Outcome(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

Secondary ID(s)

10429

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

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

Results

Results available:	Yes
Date Posted:
Date Completed:	28/09/2012
URL:

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