Complex Post-Traumatic Stress DisorderNCT04752072
RESTORE Trial: A Pilot RCT of Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) for Veterans With CPTSD
A study testing Enhanced Skills Training in Affective and Interpersonal Regulation and Treatment as usual in people with Complex Post-Traumatic Stress Disorder, run by Combat Stress at 1 site in United Kingdom.
Trial summary
Complex Post traumatic Stress Disorder (CPTSD) is now recognized as a separate trauma-based psychological condition to PTSD. CPTSD is a broader diagnosis that includes the core PTSD symptoms (re-experiencing in the here and now, avoidance, and sense of current threat) plus an additional set of symptoms that are… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complex Post-Traumatic Stress Disorder
- What is being tested?
- Enhanced Skills Training in Affective and Interpersonal Regulation and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Feb 2021to Feb 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (18 years or older) in the caseload of Combat Stress
- Armed forces veteran (United Kingdom)
- Help-seeking for trauma-related psychological distress
- Meeting diagnostic criteria for CPTSD, as measured by the ITQ (Cloitre et al., 2018)
- Proficiency in English language
- Signed informed consent provided
Who cannot join
- Severe psychotic disorder (defined by previous clinical diagnosis)
- Current alcohol or drug use disorder
- Serious cognitive impairment
- Planned concurrent additional treatment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Combat Stress
Leatherhead, Surrey, KT22 0BX
Dominic Murphy
About this study
Official title: RESTORE Trial: A Pilot RCT of Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) vs. Treatment as Usual (TAU) for Complex Posttraumatic Stress Disorder (CPTSD) in Military Personnel
Complex Post traumatic Stress Disorder (CPTSD) is now recognized as a separate trauma-based psychological condition to PTSD. CPTSD is a broader diagnosis that includes the core PTSD symptoms (re-experiencing in the here and now, avoidance, and sense of current threat) plus an additional set of symptoms that are collectively referred to as 'disturbances in self-organisation' (DSO). DSO symptoms capture pervasive psychological disturbances that are associated with traumatic exposures and that are distributed across three clusters: difficulties in affect regulation (AR), negative self-concept (NSC), and disturbances in relationships (DR).
There are no effective interventions for CPTSD. It is therefore of paramount important to identify effective interventions to treat veterans with CPTSD. The present study will be one of the first to investigate the effectiveness of a novel, modular intervention for CPTSD. Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) is a person-centered intervention that involves targeting the symptoms of CPTSD clusters sequentially using concrete modules (i.e., specific number of sessions targeting specific clusters of symptoms).
The overall aim of this study is to establish the feasibility, acceptability and preliminary effects of ESTAIR in treating CPTSD. To achieve these aims, the investigators will conduct a pilot randomised controlled trial (RCT), with a sample of 60 military veterans meeting the diagnostic criteria for CPTSD, and with two treatment arms: ESTAIR vs. a treatment-as-usual (TAU) condition.
- Conditions
- Complex Post-Traumatic Stress Disorder
- Being tested
- Enhanced Skills Training in Affective and Interpersonal Regulation, Treatment as usual
- Keywords
- CPTSD, ESTAIR, modular therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Skills Training in Affective and Interpersonal RegulationBehavioural
The first (formulation) session enables linking present difficulties and traumatic events, identifying current issues/concerns, and collaboratively agreeing on the order of modules based on symptom severity and client readiness.
The PTSD module provides narrative exposure to the traumatic memories and targets re-experiencing, avoidance and hyperarousal symptoms. The AD module focuses on identifying and labelling feelings, emotion management, distress tolerance, acceptance of feelings and experiencing positive emotions. The NSC module focuses on staying in the present moment and combating dissociation; self-compassion and mindfulness skills; challenging thinking patterns and developing a balanced view of self. The DR module focuses on exploring and revising maladaptive schemas; effective assertiveness; awareness of social context; and flexibility in interpersonal expectations and behaviours displayed in social interactions.
Treatment as usualBehavioural
The first session will involve a mental health assessment by either a psychiatrist or psychologist. A treatment package will be developed based on the information collected during the assessment. Details of the interventions delivered to each participant receiving TAU, which will include elements of psychoeducation, symptom-management and trauma-focused cognitive behaviour therapy, will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| ESTAIR | Experimental | ESTAIR (Cloitre et al., 2019) will consist of up to 25 sessions, organized in 4 modules of 6 sessions targeting symptoms of PTSD and disturbances in self-organisation (AD: affective dysregulation; NSC: negative self-concept; and DR: disturbances in relationships). Receives: Behavioral: Enhanced Skills Training in Affective and Interpersonal Regulation |
| Treatment as usual (TAU) | Active comparator | At present, there are no recommended treatments for CPTSD. TAU will consist of a treatment package that could include elements of psychoeducation, symptom-management and trauma-focused cognitive behaviour therapy, resembling established protocols for treating PTSD. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate at the end of treatment
Percentage of clients completing intervention and completing outcome measures at the end of treatment.
Measured: Post-treatment (week 25)
Retention rate at 3-months follow up
Percentage of clients completing intervention and completing outcome measures at 3-months follow up.
Measured: 3-months follow-up (week 37)
Change in symptoms of CPTSD on the International Trauma Questionnaire (ITQ) from baseline to end of treatment to 3-months follow up
The ITQ (Cloitre et al., 2018) is a validated questionnaire assessing PTSD and complex-PTSD (CPTSD). Six items represent the three clusters of PTSD (re-experiencing, avoidance and sense of threat), while another six items represent the three clusters reflecting disturbances in self-organisation (DSO) (AD: affective dysregulation; NSC: negative self-concept; and DR: disturbances in relationships. The remaining items assess functional impairment relating to symptoms of PTSD (3 items) and DSO (3 items). Items are scored using 5-point Likert scales ranging from 0 (not at all) to 4 (extremely), indicating how much a symptom has affected them in the past month.
A diagnosis of CPTSD required a diagnosis of PTSD (at least one symptom of each of its three clusters as well as functional impairment) in addition to endorsement of at least one symptom of each of the three DSO clusters plus functional impairment.
Measured: Baseline, end of treatment (week 25) and 3-months follow up (week 37)
Secondary outcomes (5)
Change in symptoms of depression on the 9-item Patient Health Questionnaire (PHQ-9) from baseline to end of treatment to 3-months follow up
The PHQ-9 (Korienke et al., 2001) is a 9-item questionnaire of depression. Items are scored using 4-point Likert scales ranging from 0 (not at all) to 3 (nearly every day), indicating how much they have been bothered by a symptom over the past two weeks. Total scores range from 0 to 27, with higher scores indicating greater levels of depression. Cut-off scores of 15 are used to identify participants likely meeting criteria for depressive disorder.
Measured: Baseline, end of treatment (week 25) and 3-months follow up (week 37)
Change in symptoms of generalised anxiety on the 7-item Generalised Anxiety Disorder Questionnaire (GAD-7) from baseline to end of treatment to 3-months follow up
The GAD-7 (Spitzer et al., 2006) is a 7-item questionnaire of generalised anxiety. Items are scored using 4-point Likert scales ranging from 0 (not at all) to 3 (nearly every day), indicating how much they have been bothered by a symptom over the past two weeks.
Total scores range from 0 to 21, with higher scores indicating greater levels of anxiety. Cut-off scores of 10 are used to identify participants likely meeting criteria for generalised anxiety disorder.
Measured: Baseline, end of treatment (week 25) and 3-months follow up (week 37)
Change in alcohol use on the 3-item (AUDIT-C) from baseline to end of treatment to 3-months follow up
The AUDIT-C (Saunders et al., 1993) consists of the first three items of the Alcohol Use Disorders Identification Test. Items are scored using a 4-point Likert scale. Total scores range from 0 to 12. Based on a nationally representative sample of adults from the United States, scores ≥ 4 effectively capture a diagnosis of Alcohol Use Disorder (AUD).
Measured: Baseline, end of treatment (week 25) and 3-months follow up (week 37)
Change in medically unexplained symptoms on the 15-item Patient Health Questionnaire-15 (PHQ-15) from baseline to end of treatment treatment to 3-months follow up
The PHQ-15 (Korienke et al., 2002) is a 15-item questionnaire of somatisation disorder symptoms. Items are scored using 4-point Likert scales ranging from 0 ("not bothered at all") to 3 ("bothered a little" or "nearly every day"), indicating how much they have been bothered by a symptom over the past two weeks. Total scores range from 0 to 30, with scores of of ≥5, ≥10, ≥15 representing mild, moderate and severe levels of somatization.
Measured: Baseline, end of treatment (week 25) and 3-months follow up (week 37)
Outcome on the single item Friends and Family Test (FFT) at end of treatment.
The FFT is a single item assessing the acceptability of an intervention (i.e., ' How likely is it that you would recommend our service to your GP, family and friends if they needed similar care?'). The item is scores on a 5-point Likert scale ranging from 1 ("extremely unlikely") to 5 ("extremely likely". The FFT is standardly administered as an end-of-treatment measure at Combat Stress
Measured: End of treatment (week 25)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start25 Feb 2021
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to the intervention arm (ESTAIR) or the control arm (TAU)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Combat Stress
- Sponsor type
- University, hospital or other
- Collaborators
- Edinburgh Napier University
- Responsible party
- Principal investigator, Prof. Dominic Murphy, Combat Stress
- Investigators
- Dominic Murphy, Prof., Principal investigator, Combat StressThanos Karatzias, Prof., Principal investigator, Edinburgh Napier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752072
- Sponsor's protocol ID
- SHSC2686062
- Other IDs
- FiMT19/0429EDU
- Status last verified
- Apr 2022
- First submitted
- 8 Feb 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collected in this study will be stored for 10 years and will not be made available to other researchers (because of the small sample sizes involved). Summary data will be provided in publications, but the individual data will not be available given the risks this raises with identification of participants. The data will not be shared except for the purposes of audit by Edinburgh Napier University or Combat Stress approved staff.
Publications
Cloitre, M., Karatzias, T., Mc Glanaghy, E. (2019). Enhanced STAIR Narrative Therapy for CPTSD. Treatment Manual. Unpublished Manuscript.
Cloitre M, Shevlin M, Brewin CR, Bisson JI, Roberts NP, Maercker A, Karatzias T, Hyland P. The International Trauma Questionnaire: development of a self-report measure of ICD-11 PTSD and complex PTSD. Acta Psychiatr Scand. 2018 Dec;138(6):536-546. doi: 10.1111/acps.12956. Epub 2018 Sep 3.
PubMed 30178492Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.
PubMed 11914441Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x.
PubMed 8329970Gray MJ, Litz BT, Hsu JL, Lombardo TW. Psychometric properties of the life events checklist. Assessment. 2004 Dec;11(4):330-41. doi: 10.1177/1073191104269954.
PubMed 15486169Hutton P, Byrne R, Pyle M, Morrison AP. Adverse Effects of Psychological Therapy Questionnaire. Unpublished; 2015.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESTORE Trial: A Pilot RCT of Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) vs. Treatment as Usual (TAU) for Complex Posttraumatic Stress Disorder (CPTSD) in Military Personnel
- ClinicalTrials.gov ID
- NCT04752072
- Acronym / sponsor ID
- SHSC2686062
- Conditions
- Complex Post-Traumatic Stress Disorder
- Keywords
- CPTSD, ESTAIR, modular therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Combat StressUniversity, hospital or other
- Collaborators
- Edinburgh Napier University
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 12 Feb 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.
Complex Post traumatic Stress Disorder (CPTSD) is now recognized as a separate trauma-based psychological condition to PTSD. CPTSD is a broader diagnosis that includes the core PTSD symptoms (re-experiencing in the here and now, avoidance, and sense of current threat) plus an additional set of symptoms that are collectively referred to as 'disturbances in self-organisation' (DSO). DSO symptoms capture pervasive psychological disturbances that are associated with traumatic exposures and that are distributed across three clusters: difficulties in affect regulation (AR), negative self-concept (NSC), and disturbances in relationships (DR).
There are no effective interventions for CPTSD. It is therefore of paramount important to identify effective interventions to treat veterans with CPTSD. The present study will be one of the first to investigate the effectiveness of a novel, modular intervention for CPTSD. Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) is a person-centered intervention that involves targeting the symptoms of CPTSD clusters sequentially using concrete modules (i.e., specific number of sessions targeting specific clusters of symptoms).
The overall aim of this study is to establish the feasibility, acceptability and preliminary effects of ESTAIR in treating CPTSD. To achieve these aims, the investigators will conduct a pilot randomised controlled trial (RCT), with a sample of 60 military veterans meeting the diagnostic criteria for CPTSD, and with two treatment arms: ESTAIR vs. a treatment-as-usual (TAU) condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to the intervention arm (ESTAIR) or the control arm (TAU)
| Arm | Type | Receives |
|---|---|---|
| ESTAIR | Experimental | Behavioral: Enhanced Skills Training in Affective and Interpersonal RegulationESTAIR (Cloitre et al., 2019) will consist of up to 25 sessions, organized in 4 modules of 6 sessions targeting symptoms of PTSD and disturbances in self-organisation (AD: affective dysregulation; NSC: negative self-concept; and DR: disturbances in relationships). |
| Treatment as usual (TAU) | Active comparator | Behavioral: Treatment as usualAt present, there are no recommended treatments for CPTSD. TAU will consist of a treatment package that could include elements of psychoeducation, symptom-management and trauma-focused cognitive behaviour therapy, resembling established protocols for treating PTSD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (18 years or older) in the caseload of Combat Stress
- Armed forces veteran (United Kingdom)
- Help-seeking for trauma-related psychological distress
- Meeting diagnostic criteria for CPTSD, as measured by the ITQ (Cloitre et al., 2018)
- Proficiency in English language
Key exclusion criteria (4 listed)
- Severe psychotic disorder (defined by previous clinical diagnosis)
- Current alcohol or drug use disorder
- Serious cognitive impairment
- Planned concurrent additional treatment
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 |
|---|---|---|
| Enhanced Skills Training in Affective and Interpersonal RegulationThe first (formulation) session enables linking present difficulties and traumatic events, identifying current issues/concerns, and collaboratively agreeing on the order of modules based on symptom severity and client readiness. The PTSD module provides narrative exposure to the traumatic memories and targets re-experiencing, avoidance and hyperarousal symptoms. The AD module focuses on identifying and labelling feelings, emotion management, distress tolerance, acceptance of feelings and experiencing positive emotions. The NSC module focuses on staying in the present moment and combating dissociation; self-compassion and mindfulness skills; challenging thinking patterns and developing a balanced view of self. The DR module focuses on exploring and revising maladaptive schemas; effective assertiveness; awareness of social context; and flexibility in interpersonal expectations and behaviours displayed in social interactions. | Behavioural | ESTAIR |
| Treatment as usualThe first session will involve a mental health assessment by either a psychiatrist or psychologist. A treatment package will be developed based on the information collected during the assessment. Details of the interventions delivered to each participant receiving TAU, which will include elements of psychoeducation, symptom-management and trauma-focused cognitive behaviour therapy, will be recorded. | Behavioural | Treatment as usual (TAU) |
Primary outcome
Retention rate at the end of treatment
Time frame: Post-treatment (week 25)
Percentage of clients completing intervention and completing outcome measures at the end of treatment.
Retention rate at 3-months follow up
Time frame: 3-months follow-up (week 37)
Percentage of clients completing intervention and completing outcome measures at 3-months follow up.
Change in symptoms of CPTSD on the International Trauma Questionnaire (ITQ) from baseline to end of treatment to 3-months follow up
Time frame: Baseline, end of treatment (week 25) and 3-months follow up (week 37)
The ITQ (Cloitre et al., 2018) is a validated questionnaire assessing PTSD and complex-PTSD (CPTSD). Six items represent the three clusters of PTSD (re-experiencing, avoidance and sense of threat), while another six items represent the three clusters reflecting disturbances in self-organisation (DSO) (AD: affective dysregulation; NSC: negative self-concept; and DR: disturbances in relationships. The remaining items assess functional impairment relating to symptoms of PTSD (3 items) and DSO (3 items). Items are scored using 5-point Likert scales ranging from 0 (not at all) to 4 (extremely), indicating how much a symptom has affected them in the past month. A diagnosis of CPTSD required a diagnosis of PTSD (at least one symptom of each of its three clusters as well as functional impairment) in addition to endorsement of at least one symptom of each of the three DSO clusters plus functional impairment.
5 secondary outcomes
Change in symptoms of depression on the 9-item Patient Health Questionnaire (PHQ-9) from baseline to end of treatment to 3-months follow up
Time frame: Baseline, end of treatment (week 25) and 3-months follow up (week 37)
Change in symptoms of generalised anxiety on the 7-item Generalised Anxiety Disorder Questionnaire (GAD-7) from baseline to end of treatment to 3-months follow up
Time frame: Baseline, end of treatment (week 25) and 3-months follow up (week 37)
Change in alcohol use on the 3-item (AUDIT-C) from baseline to end of treatment to 3-months follow up
Time frame: Baseline, end of treatment (week 25) and 3-months follow up (week 37)
Change in medically unexplained symptoms on the 15-item Patient Health Questionnaire-15 (PHQ-15) from baseline to end of treatment treatment to 3-months follow up
Time frame: Baseline, end of treatment (week 25) and 3-months follow up (week 37)
Outcome on the single item Friends and Family Test (FFT) at end of treatment.
Time frame: End of treatment (week 25)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- BackgroundCloitre, M., Karatzias, T., Mc Glanaghy, E. (2019). Enhanced STAIR Narrative Therapy for CPTSD. Treatment Manual. Unpublished Manuscript.
- Background: PubMed 30178492Cloitre M, Shevlin M, Brewin CR, Bisson JI, Roberts NP, Maercker A, Karatzias T, Hyland P. The International Trauma Questionnaire: development of a self-report measure of ICD-11 PTSD and complex PTSD. Acta Psychiatr Scand. 2018 Dec;138(6):536-546. doi: 10.1111/acps.12956. Epub 2018 Sep 3.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 11914441Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 8329970Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x.
- Background: PubMed 15486169Gray MJ, Litz BT, Hsu JL, Lombardo TW. Psychometric properties of the life events checklist. Assessment. 2004 Dec;11(4):330-41. doi: 10.1177/1073191104269954.
- BackgroundHutton P, Byrne R, Pyle M, Morrison AP. Adverse Effects of Psychological Therapy Questionnaire. Unpublished; 2015.
- Individual participant dataSharing planned: No. Data collected in this study will be stored for 10 years and will not be made available to other researchers (because of the small sample sizes involved). Summary data will be provided in publications, but the individual data will not be available given the risks this raises with identification of participants. The data will not be shared except for the purposes of audit by Edinburgh Napier University or Combat Stress approved staff.
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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.
Dominic Murphy, Prof. principal investigator
Combat Stress
Thanos Karatzias, Prof. principal investigator
Edinburgh Napier University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Skills Training in Affective and Interpersonal Regulation and Treatment as usual in people with Complex Post-Traumatic Stress Disorder, run by Combat Stress at 1 site in United Kingdom.
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 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Dominic Murphy, Prof. (01372 587 017, dominic.murphy@combatstress.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate at the end of treatment (time frame: Post-treatment (week 25)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04752072, which also lists 8 linked publications.
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 29 Apr 2022.