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IRCT20230416057921N1 IRCT 2025-07-11 Islamic Azad University Comparing the effectiveness of transdiagnostic psychotherapy and compassion-based psychotherapy on anxiety sensitivity, ambivalence, metacognitive beliefs and emotions in patients with generalized anxiety disorder Comparing the effectiveness of transdiagnostic psychotherapy and compassion-based psychotherapy on anxiety sensitivity, ambivalence, metacognitive beliefs and emotions in patients with generalized anxiety disorder 2025-06-20 anticipated 45 Complete https://irct.ir/trial/69610 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: "In this study, a simple randomization method was used to randomly assign participants to the intervention and control groups. Initially, a list of all eligible participants was created, and each was assigned a unique identification code. Subsequently, participants were assigned to groups completely at random using random number generation software. All randomization steps were designed to prevent bias. The allocation process was performed by an independent individual who was unaware of the purpose and hypotheses of the study. This individual recorded the random sequence on a sheet with codes and assigned groups, and this information was not disclosed to any of the researchers currently enrolling participants. This ensured that group selection was conducted fairly and without any external influence. Additionally, allocation information is kept in an encrypted file accessible only to the independent individual. These documented and transparent processes provide the necessary conditions for realizing random allocation and will increase the validity of the study results.", Blinding description: “In this study, participants will be provided with general information about the aims and methods of the study. However, the precise details of the intervention in the other group will not be disclosed to the participants in order to prevent potential bias. Therapy sessions for both groups (intervention and comparison) will be conducted similarly in terms of structure, number of sessions, and setting to minimize the perceived differences between the interventions for the participants. The outcome assessors, who administer the questionnaires during the pre-test and post-test phases, will also be blinded to group allocation. The data analyst will also operate in a blinded manner, and the data will be analyzed without group identifiers. N/A Generalized anxiety disorder. Intervention 1: Participants in this group will receive 10 sessions of unified transdiagnostic group psychotherapy. Each session will last 60 minutes, held weekly and in-person. The content includes integrated cognitive-behavioral techniques targeting shared processes across emotional disorders, such as worry, avoidance, and emotion regulation. The intervention will be delivered by a trained psychotherapist. Intervention 2: Intervention group: Participants in this group will attend 12 sessions of group-based compassion-focused therapy. Sessions are held weekly, in-person, and each lasts 60 minutes. The intervention is based on Gilbert’s model and includes practices related to acceptance, self-kindness, reducing self-criticism, and mindfulness. Sessions will be led by a trained therapist in compassion-focused therapy. Intervention 3: Control group: Participants in this group will not receive any intervention during the study period. After the completion of the study, they will be offered the opportunity to receive similar therapeutic services if they wish. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Faezeh Bahri
No. 9, Haft Tir 3, Haft Tir Blvd, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9178864536 +98 51 3868 4312 faezebahri2@gmail.com Islamic Azad University scientific Faezeh Bahri
No. 9, Haft Tir 3, Haft Tir Blvd, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9178864536 +98 51 3868 4312 Faezebahri2@gmail.com Islamic Azad University Iran (Islamic Republic of) Diagnosis of generalized anxiety disorder 18 years 50 years Both Substance abuse F41.1 Generalized anxiety disorder Behavior Behavior N/A Participants in this group will receive 10 sessions of unified transdiagnostic group psychotherapy. Each session will last 60 minutes, held weekly and in-person. The content includes integrated cognitive-behavioral techniques targeting shared processes across emotional disorders, such as worry, avoidance, and emotion regulation. The intervention will be delivered by a trained psychotherapist. Intervention group: Participants in this group will attend 12 sessions of group-based compassion-focused therapy. Sessions are held weekly, in-person, and each lasts 60 minutes. The intervention is based on Gilbert’s model and includes practices related to acceptance, self-kindness, reducing self-criticism, and mindfulness. Sessions will be led by a trained therapist in compassion-focused therapy Control group: Participants in this group will not receive any intervention during the study period. After the completion of the study, they will be offered the opportunity to receive similar therapeutic services if they wish. The primary outcome is anxiety sensitivity, measured by the original 16-item Anxiety Sensitivity Index (ASI) developed by Reiss et al., 1986. This outcome will be assessed at two time points: pre-test and post-test. Timepoint: T0 (Pre-test): Before the interventionT1 (Post-test): Immediately after the interventionThe outcome scores will be treated as continuous variables and analyzed using appropriate statistical methods (e.g., repeated measures ANOVA or linear mixed models) to evaluate both within-group and between-group differences. Method of measurement: Spitzer's 7-item generalized anxiety disorder scale. Rees et al.'s anxiety sensitivity scale. Questionnaire of metacognitions and positive meta-emotions. Self-administered Vakirios Ambivalence Questionnaire. Positive metacognitions and meta-emotions refer to an individual's beliefs about the usefulness or positive consequences of cognitive and emotional processes, especially when facing challenging situations. This variable includes evaluation of one's mental performance, the value of positive thoughts and emotions, and perceived control over them. This construct plays an important role in emotional regulation, coping styles, and vulnerability to psychological disorders. In this study, it will be assessed using the Positive Metacognitions and Meta-Emotions Questionnaire (Beer & Moneta, 2010). Timepoint: T0 (Pre-test): Before the interventionT1 (Post-test): Immediately after the interventionThe outcome scores will be treated as continuous variables and analyzed using appropriate statistical methods (e.g., repeated measures ANOVA or linear mixed models) to evaluate both within-group and between-group differences. Method of measurement: Positive metacognitions and meta-emotions will be measured using the Positive Metacognitions and Meta-Emotions Questionnaire (PMCEQ; Beer & Moneta, 2010). This 18-item self-report scale uses a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). Items in the first factor (irrational positive beliefs) are reverse-scored. The questionnaire comprises three subscales: (a) confidence in positive thoughts, (b) regulation of positive emotions, and (c) irrational positive beliefs. It will be administered at two timepoints: pre-intervention and post-intervention. Data will be analyzed as continuous variables. Self-ambivalence refers to the simultaneous experience of conflicting thoughts, emotions, and beliefs about oneself, often characterized by internal conflict and uncertainty regarding one's self-worth or moral values. This construct reflects cognitive and emotional inconsistencies in self-evaluation and is more prevalent among individuals with anxiety disorders. In this study, self-ambivalence will be measured using the Self-Ambivalence Questionnaire developed by Barr and Karius (2007). Timepoint: T0 (Pre-test): Before the interventionT1 (Post-test): Immediately after the interventionThe outcome scores will be treated as continuous variables and analyzed using appropriate statistical methods (e.g., repeated measures ANOVA or linear mixed models) to evaluate both within-group and between-group differences. Method of measurement: Self-ambivalence will be measured using the Self-Ambivalence Questionnaire (Barr & Karius, 2007), which contains 19 items rated on a 5-point Likert scale (0 = not at all to 4 = completely agree). The total score ranges from 0 to 76, with higher scores indicating greater ambivalence. The scale includes two subscales: ambivalence about self-worth and moral ambivalence. It will be administered at two timepoints (pre- and post-intervention), and data will be analyzed as continuous variables. Islamic Azad University Approved 2023-02-15 Ethics Committee of Azad University, Sari branch 13th Floor, Block A, Ministry of Health and Medical Education, Iran Broadcasting Rd, Between Falmak-e Jonoubi and Zarafshan, Shahrak-e Qods (Gharb), Tehran, Iran Sari Mazandaran Iran (Islamic Republic of)