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Completed

NCT Number: NCT07432139

Brief Emotion-Focused Therapy for Self-Criticism: A Comparison With a Cognitive-Behavioral Therapy Approach

The goal of this clinical trial is to determine whether Emotion-Focused Therapy (EFT) is an effective approach in reducing self-criticism in adults. EFT will be compared with Cognitive-Behavioral Therapy (CBT), a well-established treatment shown to be effective for a wide range of mental health difficulties.

The main questions the study aims to answer are:

1. Does EFT reduce self-criticism as effectively as CBT? 2. How do EFT and CBT compare in their impact on other mental health symptoms?

Participants will:

1. Receive a six-session, weekly online individual intervention (EFT or CBT), focused on reducing self-criticism. 2. Complete regular questionnaires during the intervention and at follow-up periods to track changes in self-criticism and other mental health symptoms.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maia

Maia, 4475-690, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age over 18 years old
  • Portuguese native speakers
  • elevated self-critical processes
  • perceived impact of the self-critical process on their daily functionality,
  • availability to work with self-critical processes.

Exclusion criteria

Since self-criticism is a transdiagnostic criteria for various mental disorders, the existence of a specific diagnosis is not in itself an exclusion criterion. However, participants will be excluded in case of

  • elevated dysfunctionality
  • high risk factors (such as suicide risk)
  • severe psychopathology, such as bipolar personality disorder, panic disorder, substance abuse, and personality disorders non adequate to a brief intervention previously identified.
  • changes in the therapeutic plan with psychotropic medication in the last month, if currently taking psychotropic medication
  • psychological treatment maintenance during the study implementation.

Treatment and study plan

Cognitive behavioral therapy

Behavioral

Six weekly online individual sessions using Cognitive-Behavioral Therapy (CBT) with cognitive restructuring. The intervention helps participants identify maladaptive self-critical thoughts, examine underlying beliefs, and access more adaptive and constructive thought patterns. Techniques include thought monitoring, identification of cognitive biases, the downward arrow method to explore assumptions and core beliefs, Socratic dialogue, and various techniques to challenge maladaptive thoughts and beliefs and access more adaptive ones. The intervention aims to reduce self-criticism and related clinical symptoms and to improve psychological well-being. This arm serves as an active comparator to the Emotion-Focused Therapy intervention.

Emotion Focused Therapy

Behavioral

Six weekly online individual sessions using Emotion-Focused Therapy (EFT), with a specific focus on the two-chair dialogue. The intervention addresses self-criticism as a marker of dysfunctional emotional processing, helping participants access and differentiate between the self-critical voice and the more vulnerable, experiencer self. Participants are guided to access and transform maladaptive emotional responses associated with self-criticism and integrate previously conflicting parts of the self. The intervention aims to soften maladaptive self-criticism, enhance emotional awareness, and promote overall well-being.

Primary outcomes

  1. Level of Self-Criticism

    Time frame: T1) Baseline: Within 24 hours prior to Session 1. T2-T6) Pre-session assessment : Within 24 hours before each weekly session (i.e., before sessions 2-6). T7) Post-intervention: 1 week after Session 6. T8-T9) Follow-ups: 1 and 3 months after T7.

    Measured using the Forms of Self-Criticizing/Attacking and Self-Reassuring Scale (FSCRS).

    The FSCRS provides separate scores for Inadequate Self, Hated Self, and Reassured Self. Scores range from 0 to 4, where higher scores indicate greater levels of the respective self-critical or self-reassuring tendencies.

    Reduction in the Inadequate Self and Hated Self subscales indicates improvement in self-criticism, while increases in Reassured Self indicate improvement in self-compassion.

Secondary outcomes

  1. Global Symptomatology

    Time frame: T1) Baseline: Within 24 hours prior to Session 1 T2-T6) Pre-session assessment: Within 24 hours before each weekly session (i.e., before sessions 2-6) T7) Post-intervention: 1 week after finalizing Session 6 T8-T9) Follow-ups: 1 and 3 months after T7

    Measured using the Clinical Outcome in Routine Evaluation-10 (CORE-10), a Measure of Global Symptomatology.

    The CORE-10 is a brief, self-report measure of general psychological distress experienced over the past week. It consists of 10 items assessing symptoms such as of anxiety, depression, daily functioning, and risk to self.

    Each item is rated on a 5-point Likert scale (0 = not at all to 4 = most or all of the time). Item scores are summed to yield a single total score ranging from 0 to 40, with higher scores indicating greater psychological distress and symptom severity.

    No subscale scores are calculated. The CORE-10 is widely used in clinical and research settings to monitor treatment outcomes and change over time.

  2. Mental Health Continuum - Short Form (MHC-SF):

    Time frame: T1) Baseline: Within 24 hours prior to Session 1. T6) Within 24 hours before Session 6. T7) Post-intervention: 1 week after finalizing Session 6. T8-T9) Follow-up assessments: 1 and 3 months after T7.

    The MHC-SF is a 14-item self-report measure of global mental health and wellbeing, assessing emotional, social, and psychological well-being over the last week. Items are rated on a 6-point Likert scale reflecting the frequency of specific feelings or experiences (0 = never to 5 = every day). Item scores are summed to produce a total score ranging from 0 to 70, with higher scores indicating greater overall well-being. The MHC-SF provides a global index of positive mental health and is widely used in clinical and research settings to assess well-being and monitor mental health changes over time.

  3. Depressive symptomatology

    Time frame: T1) Baseline: Within 24 hours prior to Session 1 T2-T6) Pre-session: Within 24 hours before each weekly session (i.e., before Sessions 2-6) T7) Post-intervention: 1 week after Session 6 is finalized T8-T9) Follow-up assessments: 1 and 3 months after T7

    Measured using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a self-report measure designed to assess the presence and severity of depressive symptoms over the past week. It consists of 9 items that correspond to the diagnostic criteria for major depressive disorder, including mood, sleep, appetite, energy, concentration, and suicidal thoughts. Each item is rated on a 4-point Likert scale (0 = not at all to 3 = nearly every day). Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity. The PHQ-9 is widely used in both clinical practice and research for screening, diagnosis, and monitoring treatment outcomes.

  4. Anxiety Symptomatology

    Time frame: T1) Baseline: Within 24 hours prior to Session 1. T2-T6) Pre-session: Within 24 hours before each weekly session (i.e., before Sessions 2-6). T7) Post-intervention: 1 week after Session 6 is finalized. T8-T9) Follow-up: 1 and 3 months after T7.

    Measured using the GAD-7 (Generalized Anxiety Disorder - 7-item scale):

    GAD-7 is a brief self-report measure used to assess the severity of generalized anxiety symptoms over the past week. It consists of 7 items evaluating common anxiety-related experiences, including nervousness, uncontrollable worry, restlessness, irritability, and difficulty relaxing. Each item is rated on a 4-point Likert scale (0 = not at all to 3 = nearly every day). Total scores range from 0 to 21, with higher scores indicating greater severity of anxiety. The GAD-7 is widely used in clinical and research settings for screening, assessing symptom severity, and monitoring treatment outcomes.

  5. Self-Esteem

    Time frame: T1) Baseline: Within 24 hours prior to Session 1. T2-T6) Pre-session assessment : Within 24 hours before each weekly session (i.e., before sessions 2-6). T7) Post-intervention: 1 week after Session 6. T8-T9) Follow-ups: 1 and 3 months after T7.

    Measured using: Rosenberg Self-Esteem Scale (RSES). The RSES is a widely used 10-item self-report measure assessing global self-esteem and an individual's overall sense of self-worth and self-acceptance. Each item is rated on a 4-point Likert scale (0 = strongly disagree to 3 = strongly agree). Item scores are summed to produce a total score ranging from 0 to 30, with higher scores indicating greater self-esteem. The RSES is commonly used in both research and clinical settings to evaluate self-esteem levels and monitor changes over time.

  6. Affect

    Time frame: T1) Baseline: Within 24 hours prior to Session 1. T2-T6) Pre-session assessment : Within 24 hours before each weekly session (i.e., before sessions 2-6). T7) Post-intervention: 1 week after Session 6. T8-T9) Follow-ups: 1 and 3 months after T7.

    Measured using Positive and Negative Affect Schedule (PANAS). The PANAS is a 20-item self-report measure designed to assess two primary dimensions of affect: positive affect (PA) and negative affect (NA). Each dimension consists of 10 items describing specific feelings and emotions, such as enthusiasm, alertness, distress, or nervousness. Respondents rate the extent to which they have experienced each feeling over the last week on a 5-point Likert scale (1 = very slightly or not at all to 5 = extremely). Scores for each subscale range from 10 to 50, with higher scores indicating stronger positive or negative affect. The PANAS is widely used in clinical and research settings to assess mood, emotional states, and changes in affect over time.

  7. Self-compassion

    Time frame: T1) Baseline: Within 24 hours prior to Session 1. T2-T6) Pre-session assessment : Within 24 hours before each weekly session (i.e., before sessions 2-6). T7) Post-intervention: 1 week after Session 6. T8-T9) Follow-ups: 1 and 3 months after T7.

    Measured using: Self-Compassion Scale (SCS). The SCS is a 26-item self-report measure assessing an individual's tendency to be kind and understanding toward oneself in times of difficulty or failure. Items cover six components of self-compassion: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Each item is rated on a 5-point Likert scale (1 = almost never to 5 = almost always). Higher total scores indicate greater levels of self-compassion. The SCS is widely used in research and clinical settings to evaluate self-compassion, emotional resilience, and related psychological outcomes.

  8. Working alliance

    Time frame: T5) Only administered within 24 hours prior to Session 5.

    Measured using: Working Alliance Inventory - Short Revised (WAI-SR).

    The WAI-SR is a 12-item self-report measure assessing the quality of the therapeutic alliance between a client and therapist. It evaluates three key dimensions: agreement on goals, agreement on tasks, and the development of a personal bond.

    Each item is rated on a 7-point Likert scale (1 = rarely or never to 7 = always), with total scores ranging from 12 to 84. Higher scores indicate a stronger perceived therapeutic alliance.

    In this study, the WAI-SR is assessed only before Session 5 to capture the early formation of the client-therapist relationship. Measuring at Session 5 provides a balance, reflecting a stabilized alliance while minimizing bias from treatment completion.

Sponsors and collaborators

Lead sponsor

Catarina Teixeira

Other

Registry information

Official study title

Efficacy of a Short-Term Emotion-Focused Therapy Intervention for Self-Criticism Compared With a Cognitive-Behavioral Gold Standard: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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