Patient-centered Modular CBT for CPTSD: A Randomised Controlled Pilot Study

NCT05259592 | Completed Phase 1 DMC

• 1 other identifier: SJ-871
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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:

1. 1.Assess the implementation of the trial process in terms of inclusion, implementation and data collection
2. 2.Assess necessary resources, including the use of tablets for data collection, time spent on the project by participating therapists, assessing psychologists and secretaries
3. 3.Assess changes in symptoms of CPTSD between the intervention and control group as well as within each group
4. 4.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
5. 5.Examine changes in well-being, functioning and attachment style between the intervention and control group as well as within each group
6. 6.Examine developments in client motivation and working alliance between the intervention and control group as well as within each group.
7. 7.\> 70% of potential participants accept and be included in the study
8. 8.Completion rate of 70%, that is, the investigators expect to have complete end-of-treatment data of at least 70% of all participants included
9. 9.Complete three-month follow-up of at least 50% of all participants included.

Conditions

Complex Post-Traumatic Stress Disorder

Keywords

CBT; Modular therapy; pilot randomized controlled study

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion, up to 1 year

Secondary Outcomes (8)

• The Insomnia Severity Index (ISI)

  Through study completion, up to 1 year

• The Depression Anxiety Stress Scales (DASS-42)

  Through study completion, up to 1 year

• Item 1-12 from the Common Mental Disorders Questionnaire (CMDQ)

  Through study completion, up to 1 year

• 3 items from the Alcohol Use Disorders Identification Test (AUDIT).

  Through study completion, up to 1 year

• 7 items on cannabis and other forms of drugs

  Through study completion, up to 1 year

Study Arms (2)

Modular Patient Centred CBT (MPC) for CPTSD

EXPERIMENTAL

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.

Behavioral: Psychotherapy

Modular CBT for CPTSD without co-decision

ACTIVE COMPARATOR

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).

Behavioral: Psychotherapy

Interventions

Psychotherapy BEHAVIORAL

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.

Modular CBT for CPTSD without co-decision; Modular Patient Centred CBT (MPC) for CPTSD

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danish Veterans Centre: lead
• University of Copenhagen: collaborator
• Edinburgh Napier University: collaborator

Study Sites (5)

Danish Veterans Centre, Aalborg Kaserner

Aalborg, 9400, Denmark

Location

Danish Veterans Centre, Garderkasernen

Birkerød, 3460, Denmark

Location

Danish Veterans Centre, Svanemoellen Kaserne

Copenhagen Ø, 2100, Denmark

Location

Danish Veterans Centre, Ryes Kaserne

Fredericia, 7000, Denmark

Location

Danish Veterans Centre; Ringsted Kaserne

Ringsted, 4100, Denmark

Location

Related Publications (4)

• Folke, S, Friis, K, Thomsen, U, & Roitmann, N. Modulopbygget Patient-centreret CBT til Kompleks-PTSD - behandlingsmanual version 1.0. Unpublished manual. 2020

  BACKGROUND

• 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.

  PMID: 28630973 BACKGROUND

• 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.

  PMID: 23303884 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

MeSH Terms

Conditions

Color Vision Defects

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Sofie Folke, PhD

  Military Psychology Department, Danish Veteran Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 28, 2022
• Study Start: January 5, 2021
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)