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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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26 April 2021 |
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Main ID: |
ISRCTN35772940 |
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Date of registration:
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15/01/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Complex trauma psychoeducational intervention for female offenders
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Scientific title:
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The effectiveness of a Stage 1 psychoeducational intervention versus waiting list to stabilise complex interpersonal trauma symptomatology in female offenders |
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Date of first enrolment:
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01/01/2014 |
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Target sample size:
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92 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN35772940 |
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Study type:
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Interventional |
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Study design:
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Randomized controlled trial and qualitative interviews (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Adam
Mahoney |
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Address:
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Psychology Department
HMP Cornton Vale
Cornton Road
FK9 5NU
Stirling
United Kingdom |
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Telephone:
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- |
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Email:
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Adam.Mahoney@sps.pnn.gov.uk |
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Affiliation:
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Name:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Being willing to participate voluntarily and to give written consent
2. Having experienced childhood or adulthood negative life events
3. Aged 18?70 years old
4. Being able to cope with the demands of the interviews
Exclusion criteria:
1. Unwilling to participate or unwilling to give written consent
2. Unable to cope with the demands of the interview because of mental or physical illness
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Interpersonal trauma
Mental and Behavioural Disorders
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Intervention(s)
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Participants will be randomly allocated to either a treatment group (Survive & Thrive: Psychoeducational material for complex and interpersonal trauma) or a waiting list intent-to-treat group.
Baseline assessments will assess trauma history and level of complex trauma symptomatology to establish eligibility.
Baseline measures:
1. Traumatic Antecedents Questionnaire ? Revised version 3 (TAQ, van der Kolk, 2010)
2. Self-Report Instrument for Disorders of Extreme Stress (SIDES-SR: van der Kolk, 2002)
3. Young Schema Questionnaire?Short Form 3 (YSQ-S3: Young, 2005)
A university-based statistician will assist with the randomisation of all eligible participants. Participants will be assessed blindly by the research assistant on four occasions: before treatment, post treatment as well as at 1 month and 3 months follow up. Therefore, the last assessment will be at week 17. Assessments will be conducted by means of standardised scales.
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Primary Outcome(s)
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Behavioural Assessment Checklist measured at weeks 0, 5, 9 and 17
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Secondary Outcome(s)
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1. Difficulties in Emotional Regulation Scale (DERS; Gratz & Roemer, 2004).
2. Posttraumatic Stress Disorder (PTSD) Checklist Civilian Version (PCL-C: Blanchard et al., 1996)
3. The Dissociative Experiences Scale (DES II; Carlson & Putnam, 1993)
4. Hospital Anxiety and Depression Scale (HADS: Zigmond and Snaith, 1983)
Measured pre and post intervention, and at 1 month and 3 months follow-up.
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Source(s) of Monetary Support
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Survivor Scotland (UK) (Ref No. BPS/SPS 1)
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Ethics review
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Status:
Approval date:
Contact:
1. Scottish Prison Service, 13/06/2013
2. East of Scotland Research Ethics Service (EoSRES) REC 1, 15/11/2013, REC ref: 13/ES/0111
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/03/2018 |
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URL:
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