RESTORE Trial: A Pilot RCT of Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) for Veterans With CPTSD

NCT04752072 | Unknown DMC

• 2 other identifiers: SHSC2686062FiMT19/0429EDU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Complex Post-Traumatic Stress Disorder

Keywords

CPTSD; ESTAIR; modular therapy

Outcome Measures

Primary Outcomes (3)

• Retention rate at the end of treatment

  Percentage of clients completing intervention and completing outcome measures at the end of treatment.

  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.

  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.

  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

  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

  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

  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

  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.

  End of treatment (week 25)

Other Outcomes (5)

• Experience of potentially traumatic life events on the Life Events Checklist (LEC)

  Baseline

• Rates of adverse events at end of treatment and 3-months follow up

  End of treatment (week 25) and 3-months follow up (week 37)

• Change in symptoms of CPTSD on the International Trauma Questionnaire (ITQ) following each module in ESTAIR arm only

  Week 7, Week 13, Week 19, Week 25

Study Arms (2)

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).

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.

Behavioral: Treatment as usual

Interventions

Enhanced Skills Training in Affective and Interpersonal Regulation BEHAVIORAL

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.

ESTAIR

Treatment as usual BEHAVIORAL

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.

Treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Combat Stress: lead
• Edinburgh Napier University: collaborator

Study Sites (1)

Combat Stress

Leatherhead, Surrey, KT22 0BX, United Kingdom

RECRUITING

Related Publications (8)

• Cloitre, M., Karatzias, T., Mc Glanaghy, E. (2019). Enhanced STAIR Narrative Therapy for CPTSD. Treatment Manual. Unpublished Manuscript.

  BACKGROUND

• 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.

  PMID: 30178492 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 11914441 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 8329970 BACKGROUND

• 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.

  PMID: 15486169 BACKGROUND

• Hutton P, Byrne R, Pyle M, Morrison AP. Adverse Effects of Psychological Therapy Questionnaire. Unpublished; 2015.

  BACKGROUND

MeSH Terms

Interventions

Therapeutics

Study Officials

• Dominic Murphy, Prof.

  Combat Stress

  PRINCIPAL INVESTIGATOR

• Thanos Karatzias, Prof.

  Edinburgh Napier University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominic Murphy, Prof.

CONTACT

01372 587 017; dominic.murphy@combatstress.org.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It was initially intended for the research assistant collecting post-intervention and follow-up outcome measures to be masked to arm allocation. However, it is noted that such masking is not feasible. This is not deemed a risk to the study as outcome measures are self-report measures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of research department

Model Details: Participants will be randomly allocated to the intervention arm (ESTAIR) or the control arm (TAU)

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 12, 2021
• Study Start: February 25, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)