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| ID | Type | Description | Link |
|---|---|---|---|
| 2024.02378.BD | Other Grant/Funding Number | Fundação para a Ciência e a Tecnologia (FCT, Portugal) |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emotion Focused Therapy | Experimental | Participants in this arm will receive a six-session, weekly, online individual Emotion-Focused Therapy (EFT) intervention targeting self-criticism. The core of the intervention is the two-chair dialogue, which helps participants identify and process self-critical thoughts and emotions, promote emotional transformation, and integrate different aspects of the self. |
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| Cognitive Behavioral Therapy | Active Comparator | Participants in this arm will receive a six-session, weekly, online individual Cognitive-Behavioral Therapy (CBT) intervention, focused on cognitive restructuring of self-critical thoughts. CBT is a well-established, gold-standard treatment for a broad range of mental health difficulties, and serves as an active comparator to evaluate the efficacy of the EFT intervention. The intervention helps participants identify maladaptive self-criticism, challenging underlying beliefs, and develop more adaptive thought patterns. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Self-Criticism | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Global Symptomatology | 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. |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| João Salgado, PhD | University of Maia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maia | Maia | 4475-690 | Portugal |
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| Label | URL |
|---|---|
| Website with information about the study and to facilitate participant enrolment | View source |
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Individual participant data from this study will not be shared publicly due to the sensitive nature of the psychological measures collected and to ensure participant confidentiality.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 18, 2024 | Feb 10, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D000071441 | Emotion-Focused Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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This is a randomized, parallel-group clinical trial comparing two brief online interventions (Emotion-Focused Therapy and Cognitive-Behavioral Therapy) for reducing self-criticism and clinical symptoms. Participants are randomly assigned to one of the two interventions. Therapists are blind to participants' questionnaire results during the study.
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| 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. |
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| 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 |
| Mental Health Continuum - Short Form (MHC-SF): | 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. | 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. |
| Depressive symptomatology | 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. | 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 |
| Anxiety Symptomatology | 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. | 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. |
| Self-Esteem | 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. | 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. |
| Affect | 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. | 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. |
| Self-compassion | 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. | 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. |
| Working alliance | 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. | T5) Only administered within 24 hours prior to Session 5. |