Clinical trial NCT04752072: RESTORE Trial: A Pilot RCT of Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) for Veterans With CPTSD
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complex Post-Traumatic Stress Disorder
Keywords: CPTSD
ESTAIR
modular therapy
Lead sponsor: Combat Stress
Sponsor class: OTHER
Collaborators: name: Edinburgh Napier University
First posted: 2021-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated to the intervention arm (ESTAIR) or the control arm (TAU)
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Severe psychotic disorder (defined by previous clinical diagnosis)
* Current alcohol or drug use disorder
* Serious cognitive impairment
* Planned concurrent additional treatment

Primary outcomes:
measure: Retention rate at the end of treatment
timeFrame: Post-treatment (week 25)
measure: Retention rate at 3-months follow up
timeFrame: 3-months follow-up (week 37)
measure: Change in symptoms of CPTSD on the International Trauma Questionnaire (ITQ) from baseline to end of treatment to 3-months follow up
timeFrame: Baseline, end of treatment (week 25) and 3-months follow up (week 37)
Secondary outcomes:
measure: 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
timeFrame: Baseline, end of treatment (week 25) and 3-months follow up (week 37)
measure: 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
timeFrame: Baseline, end of treatment (week 25) and 3-months follow up (week 37)
measure: Change in alcohol use on the 3-item (AUDIT-C) from baseline to end of treatment to 3-months follow up
timeFrame: Baseline, end of treatment (week 25) and 3-months follow up (week 37)
measure: 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
timeFrame: Baseline, end of treatment (week 25) and 3-months follow up (week 37)
measure: Outcome on the single item Friends and Family Test (FFT) at end of treatment.
timeFrame: End of treatment (week 25)
Other outcomes:
measure: Experience of potentially traumatic life events on the Life Events Checklist (LEC)
timeFrame: Baseline
measure: Rates of adverse events at end of treatment and 3-months follow up
timeFrame: End of treatment (week 25) and 3-months follow up (week 37)
measure: Change in symptoms of CPTSD on the International Trauma Questionnaire (ITQ) following each module in ESTAIR arm only
timeFrame: Week 7, Week 13, Week 19, Week 25
measure: Change in symptoms of the moral injury on the 14-item Moral Injury Outcome Scale (MIOS) from baseline to 3-months follow-up
timeFrame: Baseline and 3-months follow up (week 37)
measure: Qualitative data regarding acceptability of the ESTAIR intervention (ESTAIR arm only)
timeFrame: End of treatment (Week 25)
Locations:
city: Leatherhead
country: United Kingdom
facility: Combat Stress
state: Surrey
Study officials:
affiliation: Combat Stress
name: Dominic Murphy, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Edinburgh Napier University
name: Thanos Karatzias, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cloitre, M., Karatzias, T., Mc Glanaghy, E. (2019). Enhanced STAIR Narrative Therapy for CPTSD. Treatment Manual. Unpublished Manuscript.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Hutton P, Byrne R, Pyle M, Morrison AP. Adverse Effects of Psychological Therapy Questionnaire. Unpublished; 2015.