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 |
| Secondary identifying numbers | 10429 |
- 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
Scientific
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 |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 28/03/2011 |
| Completion date | 28/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Planned Sample Size: 250; UK Sample Size: 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
- England
- United Kingdom
Study participating centre
Academic Unit of Primary Health Care
Bristol
BS8 2PS
United Kingdom
BS8 2PS
United Kingdom
Sponsor information
University of Bristol (uk)
University/education
University/education
School of Social and Community Medicine
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
England
United Kingdom
"ROR" |
https://ror.org/0524sp257 |
|---|
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (Grant Codes: RP-PG-0108-10084)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 2015 results presented at Oxford 2015 - Evidence and innovation in primary care https://sapc.ac.uk/conference/2015/abstract/womens-experience-of-meaningful-change-following-domestic-abuse-qualitative |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 17/07/2013 | Yes | No | |
| Results article | results | 27/11/2018 | Yes | No |
Editorial Notes
28/11/2018: Publication reference added.
27/09/2018: Conference proceedings added to publication and dissemination plan.
