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

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. Assess the implementation of the trial process in terms of inclusion, implementation and data collection
2. 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:

1. Assess changes in symptoms of CPTSD between the intervention and control group as well as within each group
2. 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
3. Examine changes in well-being, functioning and attachment style between the intervention and control group as well as within each group
4. 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:

1. \> 70% of potential participants accept and be included in the study
2. Completion rate of 70%, that is, the investigators expect to have complete end-of-treatment data of at least 70% of all participants included
3. 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.

Conditions

• Complex Post-Traumatic Stress Disorder

Interventions

BEHAVIORAL

Psychotherapy

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.

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• Edinburgh Napier University

  collaborator OTHER

• Danish Veterans Centre

  lead OTHER_GOV

Principal Investigators

• Sofie Folke, PhD · Military Psychology Department, Danish Veteran Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-05

Primary Completion

2024-08-28

Completion

2024-08-28

Countries

• Denmark

Study Locations