search
Back to results

Survive & Thrive Trial With Male Offenders

Primary Purpose

Complex Post-Traumatic Stress Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Survive & Thrive
Sponsored by
Edinburgh Napier University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Post-Traumatic Stress Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

It is intended that as fewer prisoners as possible will be excluded from this study. Therefore, the following exclusion criteria are primarily based on ensuring the safety or the individual, other participants/staff and the good order and functioning of the prison establishment. This should include;

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Compressed

    Spaced

    Arm Description

    Treatment delivered at higher intensity - twice weekly

    Treatment delivered at lower intensity - once weekly

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    General Anxiety Disorder-7
    Measures change on self reported anxiety symptomatology. This 7-item instrument is used to briefly measure and screen for general anxiety general anxiety symptoms across various settings and populations. Items are measured on a 3 point scale from 0 ('not at all') to 3 ('nearly every day'). Symptom amelioration is indicated in a reduction in total scores.
    Patient Health Questionnaire-9
    Measures change on symptomatology associated with depressive disorders. Items are measured on a 3-point scale from 0 ('not at all') to 3 ('nearly every day'). Symptom amelioration is indicated in a reduction in total scores.
    Clinical Outcome in Routine Evaluation -10
    Measures change in self reported psychological distress to track overall progress during the course of treatment. Items are measured on a 4-point scale from 0 ('not at all') to 4 ('most or all of the time'). Symptom amelioration is indicated in a reduction in total scores.
    PTSD Checklist for DSM 5
    Measures change on PTSD symptomatology between time points. Participants respond on a 5-point scale, ranging from 'not at all' to 'extremely' as to how much the specific symptom was a problem for them over the past month. Scores are calculated resulting in a total severity score from 0 to 80. A reduction in scores indicating symptom improvement.

    Full Information

    First Posted
    April 28, 2021
    Last Updated
    May 13, 2021
    Sponsor
    Edinburgh Napier University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04887168
    Brief Title
    Survive & Thrive Trial With Male Offenders
    Official Title
    An Investigation Into the Effectiveness of Differing Treatment Intensities on a Group-based Psychoeducational Intervention for Complex Interpersonal Trauma Symptomatology With Male Offenders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2021 (Anticipated)
    Primary Completion Date
    June 1, 2023 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Edinburgh Napier University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Central to this study will be the use of non-randomised control design whereby all participants will receive treatment at the trial sites they are currently located at. The sites will deliver the intervention at different intensities either weekly (ie 'spaced') or twice weekly ('compressed'). As such the trial design is a pragmatic response to the resources made available to facilitate this trial. A sample of n = 196 male prisoners with a history of complex interpersonal trauma will be drawn from the 2 participating UK prison establishments. Participants will be initially identified by routine 'generic' and mental health assessments that consider a range of social, health and offending behaviour related needs. Those prisoners whose prior assessments indicate a history of childhood or adulthood trauma will be invited to participate in a one-off interview. Information during interviews will be collected by means of standardised questionnaires regarding the nature and extent of lifetime traumatic events and current psychopathology. All trial participants will continue their usual psychological, psychiatric, and medical care during the study. Data collection interviews will be carried out in designated interview areas within the prison or any other suitable place of their choosing. All interviews will be conducted by a research assistant, who will have experience in working with adults with complex trauma and mental health concerns. Psychoeducational Intervention: Survive & Thrive (S&T). The 'present focussed' group format is designed to be part of the process of stabilisation of clients presenting difficulties prior to embarking on work with the traumatic elements of their experiences. Survive & Thrive was designed to help clients achieve stabilisation in a resource efficient way, while at the same time providing service users with support while they are on waiting lists to access further treatment. The focus of this intervention is therefore primarily on ensuring safety, stabilisation and affect management skills. 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 per group and whilst they will be randomly selected in accordance with the procedure outlined about a local treatment manager (psychology manager) will ensure that issues all security concerns and group dynamics that might potentially mitigate the effectiveness of the intervention are accounted for. All professionals who facilitate the delivery of the programme will have a background in applied psychology or mental health and will have received standardised three-day training on the delivery of the intervention and an additional day to account for the adjustments made to S&T to assist with delivery in this population and setting. Regular supervision will also be provided during the delivery of the programme. Inclusion Criteria: All convicted male inmates over the age of 18 years old at the trial sites who indicate a history of interpersonal complex trauma will be invited to participate in this study. It should be noted that potential participants may present with different clusters of PTSD and CPTSD symptoms. A completer and an intention to treat analysis will be performed. Irrespective of time of termination all participants will be invited for an end point blind assessment. Premature termination due to recovery will be at any time, whilst patients terminating prematurely due to lack of improvement must complete at least 7 sessions in the study before they can be classified as completers. A maximum of 10 sessions will be offered as part of the project. Qualitative and quantitative procedures will analyse resultant data to establish acceptability of the intervention and the treatment efficacy of differing treatment intensities.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Complex Post-Traumatic Stress Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    non-randomised control trial
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    196 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Compressed
    Arm Type
    Experimental
    Arm Description
    Treatment delivered at higher intensity - twice weekly
    Arm Title
    Spaced
    Arm Type
    Experimental
    Arm Description
    Treatment delivered at lower intensity - once weekly
    Intervention Type
    Behavioral
    Intervention Name(s)
    Survive & Thrive
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Questionnaire about Process of Recovery
    Description
    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.
    Time Frame
    Week 0 (T1: 'Pre'), Week 5 (T2: 'Post'), Week 10 (T3: 'FU1') Week 15 (T4: 'FU2') , Week 20 (T5: 'FU3')
    Secondary Outcome Measure Information:
    Title
    General Anxiety Disorder-7
    Description
    Measures change on self reported anxiety symptomatology. This 7-item instrument is used to briefly measure and screen for general anxiety general anxiety symptoms across various settings and populations. Items are measured on a 3 point scale from 0 ('not at all') to 3 ('nearly every day'). Symptom amelioration is indicated in a reduction in total scores.
    Time Frame
    Week 0 (T1: 'Pre'), Week 5 (T2: 'Post'), Week 10 (T3: 'FU1') Week 15 (T4: 'FU2') , Week 20 (T5: 'FU3')
    Title
    Patient Health Questionnaire-9
    Description
    Measures change on symptomatology associated with depressive disorders. Items are measured on a 3-point scale from 0 ('not at all') to 3 ('nearly every day'). Symptom amelioration is indicated in a reduction in total scores.
    Time Frame
    Week 0 (T1: 'Pre'), Week 5 (T2: 'Post'), Week 10 (T3: 'FU1') Week 15 (T4: 'FU2') , Week 20 (T5: 'FU3')
    Title
    Clinical Outcome in Routine Evaluation -10
    Description
    Measures change in self reported psychological distress to track overall progress during the course of treatment. Items are measured on a 4-point scale from 0 ('not at all') to 4 ('most or all of the time'). Symptom amelioration is indicated in a reduction in total scores.
    Time Frame
    Week 0 (T1: 'Pre'), Week 5 (T2: 'Post'), Week 10 (T3: 'FU1') Week 15 (T4: 'FU2') , Week 20 (T5: 'FU3')
    Title
    PTSD Checklist for DSM 5
    Description
    Measures change on PTSD symptomatology between time points. Participants respond on a 5-point scale, ranging from 'not at all' to 'extremely' as to how much the specific symptom was a problem for them over the past month. Scores are calculated resulting in a total severity score from 0 to 80. A reduction in scores indicating symptom improvement.
    Time Frame
    Week 0 (T1: 'Pre'), Week 5 (T2: 'Post'), Week 10 (T3: 'FU1') Week 15 (T4: 'FU2') , Week 20 (T5: 'FU3')

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: It is intended that as fewer prisoners as possible will be excluded from this study. Therefore, the following exclusion criteria are primarily based on ensuring the safety or the individual, other participants/staff and the good order and functioning of the prison establishment. This should include; 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Adam L Mahoney, PhD
    Phone
    07783957402
    Email
    a.mahoney@napier.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nina Hakanpaa, PhD
    Organizational Affiliation
    Edinburgh Napier University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Survive & Thrive Trial With Male Offenders

    We'll reach out to this number within 24 hrs