Survive & Thrive Trial With Male Offenders

NCT04887168 | Unknown

• 1 other identifier: 2765584
• Study Type: interventional
• Target: 196
• Locations: 0 countries
• Sites: N/A

Brief Summary

Previous research has concluded that prison populations have particularly high rates of interpersonal trauma. There is however concern that these issues have been largely overlooked and misunderstood in the work undertaken with male offenders. The importance of addressing these concerns can be seen in the greater occurrence of mental health problems and higher reconviction rates often reported by prisoners with histories of interpersonal trauma. This study seeks to investigate complex trauma and associated symptomatology can be effectively ameliorated and whether differences in delivery intensity impact on how interventions respond most effectively to this group of survivors' needs. This is particularly relevant for forensic mental health services located in prisons, which are tasked with the care and rehabilitation of large populations of survivors.

Conditions

Complex Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Questionnaire about Process of Recovery

  Measures change on self-reported improvements in mental health and general wellbeing. This 22-item measure is developed from service users' accounts of recovery and seeks to elicit responses about aspects of recovery that are meaningful to participants. Each item is scored on a 4-point scale, from 0 ('disagree strongly') to 4 ('agree strongly') with higher scores are indicative of recovery.

  Week 0 (T1: 'Pre'), Week 5 (T2: 'Post'), Week 10 (T3: 'FU1') Week 15 (T4: 'FU2') , Week 20 (T5: 'FU3')

Secondary Outcomes (4)

• General Anxiety Disorder-7

  Week 0 (T1: 'Pre'), Week 5 (T2: 'Post'), Week 10 (T3: 'FU1') Week 15 (T4: 'FU2') , Week 20 (T5: 'FU3')

• Patient Health Questionnaire-9

  Week 0 (T1: 'Pre'), Week 5 (T2: 'Post'), Week 10 (T3: 'FU1') Week 15 (T4: 'FU2') , Week 20 (T5: 'FU3')

• Clinical Outcome in Routine Evaluation -10

  Week 0 (T1: 'Pre'), Week 5 (T2: 'Post'), Week 10 (T3: 'FU1') Week 15 (T4: 'FU2') , Week 20 (T5: 'FU3')

• PTSD Checklist for DSM 5

  Week 0 (T1: 'Pre'), Week 5 (T2: 'Post'), Week 10 (T3: 'FU1') Week 15 (T4: 'FU2') , Week 20 (T5: 'FU3')

Study Arms (2)

Compressed

EXPERIMENTAL

Treatment delivered at higher intensity - twice weekly

Behavioral: Survive & Thrive

Spaced

EXPERIMENTAL

Treatment delivered at lower intensity - once weekly

Behavioral: Survive & Thrive

Interventions

Survive & Thrive BEHAVIORAL

Psychoeducational Intervention: Survive \& Thrive (Ferguson, 2008; Mahoney et al, 2018). A total of 10 manualised sessions of approximately 1.5 hour duration are offered. Individual sessions run using an educational format and in an informal setting, with a strong emphasis on avoiding individual disclosures. Groups will be delivered utilising a multi-disciplinary work force consisting of mental health staff in a ratio of 2 per group. Groups will consist of a maximum of 8-10 participants

Compressed; Spaced

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All convicted male inmates over the age of 18 years old who indicate a history of interpersonal complex trauma will be invited to participate in this study. The ITQ will be used to identify the presence of complex trauma. It should be noted that potential participants may present with different clusters of PTSD and CPTSD symptoms; it is thought that this should not compromise the overall integrity of the study (Facer-Irwin et al, 2021). The selection process should also help to ensure:
• An adequate level of mental and physical health and substance misuse stability so as to enable them to cope with the requirements of the intervention as determined by the local Multi-disciplinary Mental Health Team (MDMHT).
• Willing to participate for therapeutic and rehabilitative reasons and to have voluntarily given their written consent.
• Serving a sentence of 6-months or more and able to complete all follow up assessments prior to their liberation.
• Have a sufficient level of literacy skills that will enable them to engage with the course written material. Learning disabilities or difficulties will be considered on a case by case basis as discussed with the Treatment Manager.
• Located in a mainstream residential location.

You may not qualify if:

• Prisoners who present as a high risk of institutional violence and requiring segregation from mainstream residential units
• Those who are on frequent observations for suicide and self-harm at any time in the week prior to the intervention starting.
• Enemies and those who have formed intimate relationships with each other whilst in custody will also be allocated to separate groups to ensure appropriate therapeutic dynamics. This will be undertaken in consultation with staff from establishment security department.

Sponsors & Collaborators

• Edinburgh Napier University: lead

MeSH Terms

Interventions

Nicotine

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Nina Hakanpaa, PhD

  Edinburgh Napier University

  STUDY DIRECTOR

Central Study Contacts

Adam L Mahoney, PhD

CONTACT

07783957402; a.mahoney@napier.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer / Chartered Forensic Psychologist

Model Details: non-randomised control trial

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 14, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share