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Modular Patient Centred CBT for Danish Veterans With Complex PTSD (MPC)

Primary Purpose

Complex Post-Traumatic Stress Disorder

Status
Recruiting
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
Danish Veterans Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Post-Traumatic Stress Disorder focused on measuring CBT; Modular therapy; pilot randomized controlled study

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meets the diagnostic criteria for CPTSD, assessed with the ITQ
  • Danish veteran (cf. the Veteran Policy of Denmark )
  • Seeks help at the Military Psychology Department, Danish Veterans Centre, for deployment-related psychological issues

Exclusion Criteria:

  • Severely suicidal
  • Current alcohol or drug abuse that prevents treatment
  • Blast injuries or current severe attention disorder
  • Has received psychotherapeutic treatment in the past three months
  • Is participating in another research project that interferes with this study

Sites / Locations

  • Danish Veterans Centre, Aalborg KasernerRecruiting
  • Danish Veterans Centre, Garderkasernen
  • Danish Veterans Centre, Svanemoellen KaserneRecruiting
  • Danish Veterans Centre, Ryes KaserneRecruiting
  • Danish Veterans Centre; Ringsted KaserneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Modular Patient Centred CBT (MPC) for CPTSD

Modular CBT for CPTSD without co-decision

Arm Description

MPC (Folke, Friis, Thomsen & Roitmann, 2020) is a treatment programme consisting of up to 32 therapy sessions broken down by five treatment modules (each consisting of six sessions). Prior to the treatment modules, the client completes an intro module (two sessions) focusing on psyhoeducation on CPTSD, individual case formulation and introduction to the further treatment programme. After the intro module (and after each treatment module), the client and therapist jointly decide which treatment module to proceed with based on 'co-decision'. The treatment modules directly address the symptoms of CPTSD: 1) Affect dysregulation, 2) Disturbed relationships, 3) Negative self-concept, 4) PTSD symptoms, and 5) Insomnia and trauma-related nightmares. Each treatment module is structured in such a way that it can be offered alone and independently of the other modules.

Because the study investigates a potentially beneficial effect of including the client directly in treatment decisions (by having the client determine the order of treatment modules together with the therapist), the patient-centred version of the treatment is compared with a control treatment, where the five treatment modules are delivered in a predefined order. The control treatment thus consists of the same treatment components as described above. It is only the aspect of co-decision that has been taken out. Instead, the therapist will just inform the client about the order of treatment modules in the programme. The order of treatment modules in the control treatment will be: 1) Affect dysregulation (6 sessions), 2) Disturbed relationships (6 sessions), 3) Negative self-concept (6 sessions), 4) PTSD symptoms (6 sessions) and 5) Insomnia and trauma-related nightmares (6 sessions).

Outcomes

Primary Outcome Measures

The International Trauma Questionnaire (ITQ; Cloitre et al., 2018)
20-item self-report scale that assesses the diagnostic criteria for PTSD and CPTSD according to ICD-11

Secondary Outcome Measures

The Insomnia Severity Index (ISI)
7-item self-report scale that assesses insomnia
The Depression Anxiety Stress Scales (DASS-42)
42-item self-reporting instrument designed to measure three related negative emotional stages of depression, anxiety and tension/stress
Item 1-12 from the Common Mental Disorders Questionnaire (CMDQ)
12 item self-report scale that assesses somatic symptoms
3 items from the Alcohol Use Disorders Identification Test (AUDIT).
Three questions about alcohol consumption; 1) how often the client consumes alcohol; 2) how many items the client consumes on a typical day, and 3) whether the client has been treated for alcohol abuse.
7 items on cannabis and other forms of drugs
Questions on cannabis and other forms of drugs. The questions have previously been used in surveys by the Danish Veteran Centre and the National Institute of Public Health, the University of Southern Denmark.
World Health Organization Well-being Index (WHO-5)
5 item self-report scale that assesses subjective psychological well-being
The Sheehan Disability Scale (SDS)
3 item self-report scale that assesses occupational, social and family functioning
The Experiences in Close Relationships - Short form (ECR-S)
12 item self-report scale that assesses adult attachment style

Full Information

First Posted
January 19, 2022
Last Updated
February 17, 2022
Sponsor
Danish Veterans Centre
Collaborators
University of Copenhagen, Edinburgh Napier University
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1. Study Identification

Unique Protocol Identification Number
NCT05259592
Brief Title
Modular Patient Centred CBT for Danish Veterans With Complex PTSD
Acronym
MPC
Official Title
Modular Patient Centred CBT for Danish Veterans With Complex PTSD: A Randomised Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Veterans Centre
Collaborators
University of Copenhagen, Edinburgh Napier University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Modular Patient Centred CBT (MPC) for Complex PTSD (CPTSD) is a manualized psychotherapy programme that consists of five treatment modules addressing 1) Affect dysregulation, 2) Disturbed relationships, 3) Negative self-concept, 4) PTSD symptoms and 5) Insomnia and trauma-related nightmares. This aim of this first pilot randomised controlled trial (RCT) is to increase chances of a future successful efficacy RCT (Phase III trial) comparing the efficacy (on symptoms of CPTSD and co-morbid disorders) of a flexible, patient-centred version of the MPC treatment programme (where the client actively participates in treatment decisions) with a control treatment, where the five treatment modules are delivered in a predefined order. The primary objective of the pilot study is to: Assess the implementation of the trial process in terms of inclusion, implementation and data collection Assess necessary resources, including the use of tablets for data collection, time spent on the project by participating therapists, assessing psychologists and secretaries The secondary objective is to: Assess changes in symptoms of CPTSD between the intervention and control group as well as within each group Examine changes in levels of comorbidity associated with CPTSD, such as anxiety, depression, insomnia, somatic complaints, drugs and alcohol intake between the intervention and control group as well as within each group Examine changes in well-being, functioning and attachment style between the intervention and control group as well as within each group Examine developments in client motivation and working alliance between the intervention and control group as well as within each group. 60 veterans with CPTSD are randomised to receive either the flexible, patient-centred version of the MPC treatment programme or the control treatment. The investigators will consider the study as complete if the following success criteria are met: > 70% of potential participants accept and be included in the study Completion rate of 70%, that is, the investigators expect to have complete end-of-treatment data of at least 70% of all participants included Complete three-month follow-up of at least 50% of all participants included. The project neither collects new biological material nor biological material from existing biobanks. The project is based on questionnaire data.
Detailed Description
ICD-11 complex PTSD (CPTSD) is a new diagnosis and up to this date, no effective treatment has been identified to help clients with this severe mental disorder. Therefore, it is very important that effective treatment methods for clients with CPTSD be identified. In 2019 the Danish Veteran Centre launched the development of a treatment programme for veterans with CPTSD; Modular Patient Centred CBT (MPC) for CPTSD. MPC is a manualised treatment programme that consists of 32 individual psychotherapy sessions, divided into an initial treatment module (two therapy sessions) and five treatment modules (each consisting of six therapy sessions) that can be combined in different ways to adapt to each client's most prominent symptoms, preferences and readiness (to work with exposure, for instance). The five treatment modules address 1) Affect dysregulation (6 sessions), 2) Disturbed relationships (6 sessions), 3) Negative self-concept (6 sessions), 4) PTSD symptoms (6 sessions) and 5) Insomnia and trauma-related nightmares (6 sessions). This first trial of the MPC treatment programme is conducted as a pilot randomised controlled trial. The primary objective of this study is to increase chances of a future successful efficacy RCT (Phase III trial) comparing the efficacy (on symptoms of CPTSD and co-morbid disorders) of a flexible, patient-centred version of the MPC treatment programme (where the client actively participates in treatment decisions) with a control treatment, where the five treatment modules are delivered in a predefined order; 1) Affect dysregulation, 2) Disturbed relationships, 3) Negative self-concept, 4) PTSD symptoms, and 5) Insomnia and trauma-related nightmares. The primary objective of the pilot study is to: Assess the implementation of the trial process in terms of inclusion, implementation and data collection Assess necessary resources, including the use of tablets for data collection, time spent on the project by participating therapists, assessing psychologists and secretaries The secondary objective is to: Assess changes in symptoms of CPTSD, assessed with the International Trauma Questionnaire (ITQ; Cloitre et al., 2018) between the intervention and control group as well as within each group Examine changes in levels of comorbidity associated with CPTSD, such as anxiety, depression, insomnia, somatic complaints, drugs and alcohol intake between the intervention and control group as well as within each group Examine changes in well-being, functioning and attachment style between the intervention and control group as well as within each group Examine developments in client motivation and working alliance between the intervention and control group as well as within each group. 60 veterans with CPTSD are randomised to receive either the flexible, patient-centred version of the MPC treatment programme or the control treatment. As an integral part of the treatment, a short assessment is conducted after each treatment module by having the client complete the primary outcome measure, the ITQ which is used as a measure for assessing ICD-11 PTSD and CPTSD. In practice, the client fills in the ITQ on a tablet in the beginning of the last session of each treatment module, after which the client and therapist receive an automatic response on the tablet, establishing whether the client (based on the ITQ) continues to meet the diagnostic criteria for PTSD or CPTSD. If the client has achieved sufficient symptom recovery and no longer meets the diagnostic criteria for CPTSD, the client is considered a treatment completer. However, the client and the therapist might decide to continue treatment until the client no longer meets the diagnostic criteria for PTSD. In this way, treatment can continue to up till 32 therapy sessions but client and therapist can end the treatment earlier if the client has a valid assessment and falls out of CPTSD criteria. Since the study is a pilot study, aiming to inform a future RCT, the investigators will consider the study as complete if the following success criteria are met: > 70% of potential participants accept and be included in the study Completion rate of 70%, that is, the investigators expect to have complete data (end-of-treatment outcome assessment completed at the final therapy session) of at least 70% of all participants included Complete three-month follow-up of at least 50% of all participants included. The treatment is carried out at five local veteran centres in Denmark by clinical psychologists employed by the Military Psychology Department (MPD), Danish Veterans Centre. The participating psychologists receive training and regular method-specific supervision in the MPC treatment programme. The project neither collects new biological material nor biological material from existing biobanks. The project is based on questionnaire data

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Post-Traumatic Stress Disorder
Keywords
CBT; Modular therapy; pilot randomized controlled study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
The study is a randomised controlled pilot study that follows the guidelines of the Consolidated Standards of Reporting Trials (CONSORT; Boutron et al., 2017) and the SPIRIT guidelines (Chan et al., 2013). 60 Danish veterans with complex PTSD (CPTSD) will be randomised to either modular patient-centred CBT (MPC) or a control treatment, where the order of the treatment modules is determined in advance. A randomisation list was prepared using R software (www.r-project.org). Participants are randomised into the intervention group or the control group with 30 participants in each group, stratified by recruitment/treatment site. A block size of six will be used to ensure an even balance. The randomisation was pre-pared by a data manager affiliated with the project, and only he is able to see the randomisation list.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modular Patient Centred CBT (MPC) for CPTSD
Arm Type
Experimental
Arm Description
MPC (Folke, Friis, Thomsen & Roitmann, 2020) is a treatment programme consisting of up to 32 therapy sessions broken down by five treatment modules (each consisting of six sessions). Prior to the treatment modules, the client completes an intro module (two sessions) focusing on psyhoeducation on CPTSD, individual case formulation and introduction to the further treatment programme. After the intro module (and after each treatment module), the client and therapist jointly decide which treatment module to proceed with based on 'co-decision'. The treatment modules directly address the symptoms of CPTSD: 1) Affect dysregulation, 2) Disturbed relationships, 3) Negative self-concept, 4) PTSD symptoms, and 5) Insomnia and trauma-related nightmares. Each treatment module is structured in such a way that it can be offered alone and independently of the other modules.
Arm Title
Modular CBT for CPTSD without co-decision
Arm Type
Active Comparator
Arm Description
Because the study investigates a potentially beneficial effect of including the client directly in treatment decisions (by having the client determine the order of treatment modules together with the therapist), the patient-centred version of the treatment is compared with a control treatment, where the five treatment modules are delivered in a predefined order. The control treatment thus consists of the same treatment components as described above. It is only the aspect of co-decision that has been taken out. Instead, the therapist will just inform the client about the order of treatment modules in the programme. The order of treatment modules in the control treatment will be: 1) Affect dysregulation (6 sessions), 2) Disturbed relationships (6 sessions), 3) Negative self-concept (6 sessions), 4) PTSD symptoms (6 sessions) and 5) Insomnia and trauma-related nightmares (6 sessions).
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
Modular Patient Centred CBT (MPC) for CPTSD (Folke, Friis, Thomsen & Roitmann, 2020) is a psychotherapy treatment manual consisting of up to 32 individual therapy sessions broken down by five treatment modules (each consisting of six sessions) that directly address the symptoms of CPTSD: 1) Affect dysregulation, 2) Disturbed relationships, 3) Negative self-concept, 4) PTSD symptoms, and 5) Insomnia and trauma-related nightmares.
Primary Outcome Measure Information:
Title
The International Trauma Questionnaire (ITQ; Cloitre et al., 2018)
Description
20-item self-report scale that assesses the diagnostic criteria for PTSD and CPTSD according to ICD-11
Time Frame
Through study completion, up to 1 year
Secondary Outcome Measure Information:
Title
The Insomnia Severity Index (ISI)
Description
7-item self-report scale that assesses insomnia
Time Frame
Through study completion, up to 1 year
Title
The Depression Anxiety Stress Scales (DASS-42)
Description
42-item self-reporting instrument designed to measure three related negative emotional stages of depression, anxiety and tension/stress
Time Frame
Through study completion, up to 1 year
Title
Item 1-12 from the Common Mental Disorders Questionnaire (CMDQ)
Description
12 item self-report scale that assesses somatic symptoms
Time Frame
Through study completion, up to 1 year
Title
3 items from the Alcohol Use Disorders Identification Test (AUDIT).
Description
Three questions about alcohol consumption; 1) how often the client consumes alcohol; 2) how many items the client consumes on a typical day, and 3) whether the client has been treated for alcohol abuse.
Time Frame
Through study completion, up to 1 year
Title
7 items on cannabis and other forms of drugs
Description
Questions on cannabis and other forms of drugs. The questions have previously been used in surveys by the Danish Veteran Centre and the National Institute of Public Health, the University of Southern Denmark.
Time Frame
Through study completion, up to 1 year
Title
World Health Organization Well-being Index (WHO-5)
Description
5 item self-report scale that assesses subjective psychological well-being
Time Frame
Through study completion, up to 1 year
Title
The Sheehan Disability Scale (SDS)
Description
3 item self-report scale that assesses occupational, social and family functioning
Time Frame
Through study completion, up to 1 year
Title
The Experiences in Close Relationships - Short form (ECR-S)
Description
12 item self-report scale that assesses adult attachment style
Time Frame
Through study completion, up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets the diagnostic criteria for CPTSD, assessed with the ITQ Danish veteran (cf. the Veteran Policy of Denmark ) Seeks help at the Military Psychology Department, Danish Veterans Centre, for deployment-related psychological issues Exclusion Criteria: Severely suicidal Current alcohol or drug abuse that prevents treatment Blast injuries or current severe attention disorder Has received psychotherapeutic treatment in the past three months Is participating in another research project that interferes with this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sofie Folke, PhD
Phone
72163251
Email
vetc-mpa43@mil.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Søren B. Andersen, PhD
Phone
72819730
Email
vetc-chvic@mil.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofie Folke, PhD
Organizational Affiliation
Military Psychology Department, Danish Veteran Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Veterans Centre, Aalborg Kaserner
City
Aalborg
ZIP/Postal Code
9400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofie Folke, PhD
Phone
72163251
Email
vetc-mpa43@mil.dk
Facility Name
Danish Veterans Centre, Garderkasernen
City
Birkerød
ZIP/Postal Code
3460
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofie Folke, PhD
Phone
72163251
Email
vetc-mpa43@mil.dk
Facility Name
Danish Veterans Centre, Svanemoellen Kaserne
City
Copenhagen Ø
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofie Folke, PhD
Phone
72163251
Email
vetc-mpa43@mil.dk
Facility Name
Danish Veterans Centre, Ryes Kaserne
City
Fredericia
ZIP/Postal Code
7000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofie Folke, PhD
Phone
72163251
Email
vetc-mpa43@mil.dk
Facility Name
Danish Veterans Centre; Ringsted Kaserne
City
Ringsted
ZIP/Postal Code
4100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofie Folke, PhD
Phone
72163251
Email
vetc-mpa43@mil.dk
First Name & Middle Initial & Last Name & Degree
Søren B Andersen, PhD
Phone
72819734

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Due to privacy and data protection regulations of the Danish Defence, data from the current study cannot be shared.
Citations:
Citation
Folke, S, Friis, K, Thomsen, U, & Roitmann, N. Modulopbygget Patient-centreret CBT til Kompleks-PTSD - behandlingsmanual version 1.0. Unpublished manual. 2020
Results Reference
background
PubMed Identifier
28630973
Citation
Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P; CONSORT NPT Group. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017 Jul 4;167(1):40-47. doi: 10.7326/M17-0046. Epub 2017 Jun 20.
Results Reference
background
PubMed Identifier
23303884
Citation
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
Results Reference
background
PubMed Identifier
30178492
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.
Results Reference
background

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Modular Patient Centred CBT for Danish Veterans With Complex PTSD

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