The Effectiveness of CFT for Reducing Self-criticism in Patients with Complex PTSD: a Single-case Experimental Study

NCT ID: NCT05791760

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-19
• Study Completion Date: 2025-12-31

Brief Summary

PTSD is a mental disorder including psychological symptoms related to severe traumatic event(s). PTSD can negatively affect people's functioning in several life domains. Several effective therapies for the treatment of PTSD have been developed in recent decades. However, these treatments are not effective for every patient. Several studies show that people suffering from PTSD also experience feelings of trauma-related guilt, shame, self-blame and negative self-evaluation. These emotions may contribute to the maintenance cycle of PTSD or even become worse over time. In particularly in patients with trauma who have been exposed to repeated traumatic experiences within the context of interpersonal relationships including childhood sexual/physical abuse and domestic violence. This type of trauma is known as complex PTSD. cPTSD is marked by severe difficulties in problems with self and emotion-regulation, relationship difficulties and shame. One key factor for reducing self-criticism in individuals might be self-compassion as the antidote to self-criticism and shame. Compassion focused therapy by Paul Gilbert focuses specifically on increasing self-compassion. Although some studies show promising results of CFT in patients with cPTSS, the effectiveness for this group has not yet been sufficiently examined. Therefore, this Single case experimental design study is conducted with the primary objective of examining the effectiveness of CFT in reducing the primary outcome self-criticism. Secondary outcomes that will be examined are CFT reduces PTSD symptoms and shame and increases self-compassion and well-being.

This SCED study is a noncurrent multiple baseline across subjects study, consisting of three phases with twice-weekly repeated measurements of self-criticism. First the pre-intervention baseline phase, in which participants are randomly assigned to different baseline lengths (either 5, 6 or 7 weeks). The second phase is the subsequent CFT-intervention, consisting of 12 weeks of weekly CFT group sessions with two-weekly assessments of self-criticism. The third phase is follow up for 5 weeks from the end of the intervention, again including two-weekly assessments of self-criticism. By comparing the baseline phases with the intervention and follow-up phases for individual participants, the effectiveness of the CFT intervention on self-critical beliefs can be determined. Changes that occur within participants can be seen as evidence of intervention effectiveness.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Compassion-focused therapy (CFT)

Group Type: EXPERIMENTAL

Compassion-focused therapy (CFT) for complex PTSD

Intervention Type: BEHAVIORAL

The group protocol includes 12 two-hour sessions. Each session begins and ends with a practical exercise (calming rhythmic breathing) and each session includes psychoeducation (conceptualization, self-compassion). At the end of the session, participants are asked to practice at home between sessions (1 hour per week). The protocol consisted of 3 parts; sessions 1-5 focused on compassion understanding, including psychoeducation on emotion regulation, self-compassion skills, and mindfulness skills. Sessions 6-8 focused on motivation to care, compassion from others, the compassionate self, and the relationship between the compassionate self and self-criticism. Sessions 9-12 focused on using compassion in daily life. The group has a maximum of nine participants and is given by three therapists. All therapists are pre-trained to apply the intervention.

Interventions

Compassion-focused therapy (CFT) for complex PTSD

The group protocol includes 12 two-hour sessions. Each session begins and ends with a practical exercise (calming rhythmic breathing) and each session includes psychoeducation (conceptualization, self-compassion). At the end of the session, participants are asked to practice at home between sessions (1 hour per week). The protocol consisted of 3 parts; sessions 1-5 focused on compassion understanding, including psychoeducation on emotion regulation, self-compassion skills, and mindfulness skills. Sessions 6-8 focused on motivation to care, compassion from others, the compassionate self, and the relationship between the compassionate self and self-criticism. Sessions 9-12 focused on using compassion in daily life. The group has a maximum of nine participants and is given by three therapists. All therapists are pre-trained to apply the intervention.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• The participant is between 18 and 65 years old.
• Diagnosis of cPTSD and severe problems with self criticism (as diagnosed by an experienced clinican).
• The participant gives consent to participate in the study using the online informed consent procedure.
• Sufficient Dutch language proficiency and average intelligence.
• The participant has an e-mail address and is in possession of a smartphone or tablet with access to the internet.
• The participant is willing to complete twice-weekly questionnaires for up to 24 weeks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Twente

OTHER

Sponsor Role: lead

Responsible Party

Jannis Kraiss

Assistant professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Twente

Enschede, Overijssel, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

esther baas

Role: CONTACT

e.baas01@mediant.nl

+31534755755

jannis kraiss, PhD

Role: CONTACT

j.t.kraiss@utwente.nl

+3153 489 7512

Other Identifiers

UTwente

Identifier Type: -

Identifier Source: org_study_id