Posttraumatic Stress DisorderNCT05791760
The Effectiveness of CFT for Reducing Self-criticism in Patients With Complex PTSD: a Single-case Experimental Study
A study testing Compassion-focused therapy (CFT) for complex PTSD in people with Posttraumatic Stress Disorder, run by University of Twente at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Compassion-focused therapy (CFT) for complex PTSD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Mar 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Compassion Focused Therapy (CFT) for Reducing Self-criticism in Female Patients With Complex PTSD: a Single-case Experimental Study
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
- Being tested
- Compassion-focused therapy (CFT) for complex PTSD
- Keywords
- PTSD, Shame, Compassion, Well-being
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion-focused therapy (CFT) for complex PTSDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Compassion-focused therapy (CFT) | Experimental | Not described Receives: Behavioral: Compassion-focused therapy (CFT) for complex PTSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-criticism
Measured with the Forms of Self-Criticizing/Attacking and Self-Reassuring Scale (FSCRS-SF). It contains 14 items and is a valid and sensitive measurement scale with adequate psychometric properties including structural validity, convergent validity and sensitivity to change. Higher scores indicate more self-criticism and more self-reassurance. Mean scores range from 0 to 4.
Measured: Up to 24 weeks
Secondary outcomes (4)
PTSD symptoms
The Post Traumatic Checklist Scale (PCL-5) measures the extent in which participant's experienced PTSD symptoms in the past month. It contains 20 items and is a valid and reliable questionnaire for screening and assessing PTSD in clinical practice. Higher scores indicate more PTSD symptoms. Total scores range from 0 to 80.
Measured: Posttest (T1); 3 months after baseline
Self-compassion
Self compassion will be measured with the Self-Compassion Scale-Short Form (SCS-SF). The SCS-SF contains 12 items. Higher scores reflect higher levels of self-compassion. The Dutch version of the SCS-SF has adequate psychometric qualities. Mean scores range from 0 to 5.
Measured: Posttest (T1); 3 months after baseline
Well-being
The 14-item Mental Health Continuum-Short Form (MHC-SF) measures well-being. Higher scores indicate more well-being. The MHC-SF has shown very good psychometric properties in previous studies. Mean scores range from 0 to 5.
Measured: Posttest (T1); 3 months after baseline
Shame
Experiences of Shame Scale (ESS) is the version of Andrews' Experience of Shame Scale (ESS). The ESS distinguishes between characteristic, behavioral and physical shame. The test consists of 25 statements related to shame. Mean scores rang from 1 to 4 with higher scores indicating more Shame.
Measured: Posttest (T1); 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start19 Mar 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jannis Kraiss, University of Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791760
- Sponsor's protocol ID
- UTwente
- Status last verified
- Apr 2026
- First submitted
- 13 Mar 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Compassion Focused Therapy (CFT) for Reducing Self-criticism in Female Patients With Complex PTSD: a Single-case Experimental Study
- ClinicalTrials.gov ID
- NCT05791760
- Acronym / sponsor ID
- UTwente
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, Shame, Compassion, Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of TwenteUniversity, hospital or other
- Study start
- 19 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compassion-focused therapy (CFT) | Experimental | Behavioral: Compassion-focused therapy (CFT) for complex PTSD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compassion-focused therapy (CFT) for complex PTSDThe 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. | Behavioural | Compassion-focused therapy (CFT) |
Primary outcome
Self-criticism
Time frame: Up to 24 weeks
Measured with the Forms of Self-Criticizing/Attacking and Self-Reassuring Scale (FSCRS-SF). It contains 14 items and is a valid and sensitive measurement scale with adequate psychometric properties including structural validity, convergent validity and sensitivity to change. Higher scores indicate more self-criticism and more self-reassurance. Mean scores range from 0 to 4.
4 secondary outcomes
PTSD symptoms
Time frame: Posttest (T1); 3 months after baseline
Self-compassion
Time frame: Posttest (T1); 3 months after baseline
Well-being
Time frame: Posttest (T1); 3 months after baseline
Shame
Time frame: Posttest (T1); 3 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion-focused therapy (CFT) for complex PTSD in people with Posttraumatic Stress Disorder, run by University of Twente at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-criticism (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.