Complex Post-Traumatic Stress DisorderNCT04887168
Survive & Thrive Trial With Male Offenders
A study testing Survive & Thrive in people with Complex Post-Traumatic Stress Disorder, run by Edinburgh Napier University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Complex Post-Traumatic Stress Disorder
- What is being tested?
- Survive & Thrive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Complex Post-Traumatic Stress Disorder
- Being tested
- Survive & Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survive & ThriveBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Compressed | Experimental | Treatment delivered at higher intensity - twice weekly Receives: Behavioral: Survive & Thrive |
| Spaced | Experimental | Treatment delivered at lower intensity - once weekly Receives: Behavioral: Survive & Thrive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Week 0 (T1: 'Pre'), Week 5 (T2: 'Post'), Week 10 (T3: 'FU1') Week 15 (T4: 'FU2') , Week 20 (T5: 'FU3')
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.
Measured: 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
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.
Measured: 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
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.
Measured: Week 0 (T1: 'Pre'), Week 5 (T2: 'Post'), Week 10 (T3: 'FU1') Week 15 (T4: 'FU2') , Week 20 (T5: 'FU3')
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- non-randomised control trial
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edinburgh Napier University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Louis Mahoney, Edinburgh Napier University
- Investigators
- Nina Hakanpaa, PhD, Study director, Edinburgh Napier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887168
- Sponsor's protocol ID
- 2765584
- Status last verified
- May 2021
- First submitted
- 28 Apr 2021
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04887168
- Acronym / sponsor ID
- 2765584
- Conditions
- Complex Post-Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Edinburgh Napier UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non-randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Compressed | Experimental | Behavioral: Survive & ThriveTreatment delivered at higher intensity - twice weekly |
| Spaced | Experimental | Behavioral: Survive & ThriveTreatment delivered at lower intensity - once weekly |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survive & ThrivePsychoeducational 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 | Behavioural | Compressed, Spaced |
Primary outcome
Questionnaire about Process of Recovery
Time frame: Week 0 (T1: 'Pre'), Week 5 (T2: 'Post'), Week 10 (T3: 'FU1') Week 15 (T4: 'FU2') , Week 20 (T5: 'FU3')
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.
4 secondary outcomes
General Anxiety Disorder-7
Time frame: Week 0 (T1: 'Pre'), Week 5 (T2: 'Post'), Week 10 (T3: 'FU1') Week 15 (T4: 'FU2') , Week 20 (T5: 'FU3')
Patient Health Questionnaire-9
Time frame: 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
Time frame: 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
Time frame: Week 0 (T1: 'Pre'), Week 5 (T2: 'Post'), Week 10 (T3: 'FU1') Week 15 (T4: 'FU2') , Week 20 (T5: 'FU3')
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Hakanpaa, PhD study director
Edinburgh Napier University
Questions about this trial
What is this clinical trial studying?
A study testing Survive & Thrive in people with Complex Post-Traumatic Stress Disorder, run by Edinburgh Napier University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam L Mahoney, PhD (07783957402, a.mahoney@napier.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire about Process of Recovery (time frame: Week 0 (T1: 'Pre'), Week 5 (T2: 'Post'), Week 10 (T3: 'FU1') Week 15 (T4: 'FU2') , Week 20 (T5: 'FU3')). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.