RESTORE Trial: A Pilot RCT of Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) for Veterans With CPTSD
NCT ID: NCT04752072
Last Updated: 2022-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-02-25
2023-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ESTAIR
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).
Enhanced Skills Training in Affective and Interpersonal Regulation
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 usual (TAU)
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.
Treatment as usual
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.
Interventions
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Enhanced Skills Training in Affective and Interpersonal Regulation
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 usual
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Current alcohol or drug use disorder
* Serious cognitive impairment
* Planned concurrent additional treatment
18 Years
ALL
Yes
Sponsors
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Edinburgh Napier University
OTHER
Combat Stress
OTHER
Responsible Party
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Prof. Dominic Murphy
Head of research department
Principal Investigators
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Dominic Murphy, Prof.
Role: PRINCIPAL_INVESTIGATOR
Combat Stress
Thanos Karatzias, Prof.
Role: PRINCIPAL_INVESTIGATOR
Edinburgh Napier University
Locations
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Combat Stress
Leatherhead, Surrey, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Dominic Murphy
Role: primary
References
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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.
Kroenke 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.
Kroenke 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.
Spitzer 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.
Saunders 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.
Gray 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.
Hutton P, Byrne R, Pyle M, Morrison AP. Adverse Effects of Psychological Therapy Questionnaire. Unpublished; 2015.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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FiMT19/0429EDU
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SHSC2686062
Identifier Type: -
Identifier Source: org_study_id
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