NCT05259592: PACE pilot RCT

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

Completed Phase 1, PHASE2 Last updated 2 April 2025

What this trial tests

Phase 1, PHASE2 trial testing Psychotherapy in Complex Post-Traumatic Stress Disorder in 60 participants. Completed in 28 August 2024.

Timeline

5 January 2021

Primary endpoint
28 August 2024

28 August 2024

Quick facts

Lead sponsor	Danish Veterans Centre
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	5 January 2021
Primary completion	28 August 2024
Estimated completion	28 August 2024
Sites	5 locations across Denmark

Drugs / interventions tested

• Psychotherapy

Conditions studied

• Complex Post-Traumatic Stress Disorder — all drugs for Complex Post-Traumatic Stress Disorder →

Sponsor

Danish Veterans Centre

Who can join

Adults 18 to 99, any sex, with Complex Post-Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.