The Effectiveness of Transdiagnostic CBT Protocol on Anxiety Disorders

NCT ID: NCT06422728

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-20
• Study Completion Date: 2025-01-31

Brief Summary

The transdiagnostic approach argues that the common features are needed to be taken into account [e.g. distress intolerance (DI), intolerance of uncertainty (IU), worry)] underlying emotional disorders rather than evaluating them separately due to the fact that the dissection of anxiety disorders has increased with each emerging version of the Diagnostic and Statistical Manual of Mental Disorders (DSM), in which the classification of anxiety disorders resulted in an increased number of intervention protocols for each disorder. This also caused an increase of comorbidity among anxiety disorders. Transdiagnostic approach offers a unified protocol (UP) for strengthening the common features, and thereby both preventing the emergence of emotional disorders or intervening the symptom severity of emotional disorders, which can be applied to different types of emotional disorders. The main aim of this study is to develop a UP which is planned to be applied as a group therapy. The UP will include interventions developing the levels of common transdiagnostic features (DI, IU and worry). The study's second aim is to investigate the effect of the developed UP on DI, IU and worry. The third one is to search the effect of the developed UP on symptom severity levels of anxiety disorders. Fourthly, this study will search if the levels of transdiagnostic common features (DI, IU and worry) will predict the levels of symptom severity of anxiety disorders'.

Detailed Description

The transdiagnostic approach argues that common features are needed to be taken into account [e.g. distress intolerance (DI), intolerance of uncertainty (IU), worry] underlying emotional disorders rather than evaluating them separately since the dissection of anxiety disorders has increased with each emerging version of the Diagnostic and Statistical Manual of Mental Disorders (DSM), in which the classification of anxiety disorders resulted in an increased number of intervention protocols for each disorder. That is why an increase in comorbidity among anxiety disorders is observed. The transdiagnostic approach offers a unified protocol (UP) for strengthening the common features, thereby preventing the emergence and intervening in several emotional disorders.

As part of dissertation, the main aim of this study is to develop UP in Turkish, and measure the effectiveness of the UP on anxiety disorders and the transdiagnostic features. The UP is planned in group therapy format and includes interventions strengthening the common transdiagnostic features (DI, IU, and worry). This protocol is based on cognitive behavioral therapy (CBT) model. The sessions in the protocol are planned as follows:

Session 1 is assessment session and Session 2 is on psychoeducation, which mainly intend to introduce the CBT model. In session 3, emotions are discussed, revealing that emotions point out what is important for us in life. In session 4, 5 and 6, thoughts are worked on. The participants learn to deal with worry and to challenge unfunctional thoughts and generate alternative explanations. Session 7 focuses on behaviors, in which the role of behaviors and the things that can/cannot be controlled are discussed. Session 8 includes a review of what has been learnt during the group therapy and an evaluation on maintaining the accomplishments. In addition, a follow-up session is planned after one month.

In this study, there will be an intervention (UP) group and a control group. The participants will be assigned to the groups randomly. The measurements are the Distress Intolerance Scale (DTS), Intolerance of Uncertainty Scale-12 (IUS-12), Penn State Worry Questionnaire (PSWQ), Metacognitions Questionnaire-30 (MCQ-30), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder Assessment (GAD-7).

The uniqueness of this protocol is to be the first UP in Turkish with its own order. It is expected to promote transdiagnostic studies in Turkey. This research is also important in contributing to the literature on transdiagnostic studies, which offer an alternative to comorbidity and a decrease in the symptom severity of anxiety disorders.

Conditions

Anxiety Disorders; Social Anxiety Disorder; Generalized Anxiety Disorder; Panic Disorder; Anxiety Disorder NOS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Transdiagnostic Unified Protocol

The intervention group will receive the transdiagnostic unified protocol (UP) for anxiety disorders that is developed in this study. The UP is based on CBT model and will last for 8 weeks and there will be a follow-up session after one month. Each session will last 1 and a half hours. The pre-, post- and follow-up tests will be given to them to test the effectiveness of the UP.

Group Type: EXPERIMENTAL

Unified Protocol for Anxiety Disorders

Intervention Type: OTHER

The UP is planned in group therapy format and includes interventions on common transdiagnostic features. The sessions in the protocol are planned as follows:

Session 1 - Assessment: introduction, talking on group rules and the process, setting goals

Session 2 - Psychoeducation: the CBT model is introduced.

Session 3 - Emotions: the role of emotions are discussed.

Session 4, 5 & 6 - Thoughts: the role of thoughts is mentioned. The participants learn to challenge unfunctional thoughts and generate alternative explanations. Also, exercises on excessive worry are applied.

Session 7 - Behaviors: the role of behaviors and the things that can/cannot be controlled are discussed.

Session 8 - Evaluation & Maintaining Accomplishments: includes a review of what has been learnt during the group therapy and an evaluation on maintaining the accomplishments.

Session 9 - Follow-up session: one month later.

Client-Centered Supportive Therapy

The supportive therapy group will also last for 8 weeks and there will be a follow-up session after one month. Each session will last 1 and a half hours. The pre-, post- and follow-up tests will be given to them, too.

Group Type: ACTIVE_COMPARATOR

Client-centered Supportive Therapy

Intervention Type: OTHER

Client-entered therapy provides a non-directive supportive environment for the participants, that includes reflective listening and nonjudgmental and empathic communication. In this group, no CBT intervention will be applied. Through the supportive and non-directive environment, only the effect of relationship will be investigated as a common factor in psychotherapy.

Interventions

Unified Protocol for Anxiety Disorders

The UP is planned in group therapy format and includes interventions on common transdiagnostic features. The sessions in the protocol are planned as follows:

Session 1 - Assessment: introduction, talking on group rules and the process, setting goals

Session 2 - Psychoeducation: the CBT model is introduced.

Session 3 - Emotions: the role of emotions are discussed.

Session 4, 5 & 6 - Thoughts: the role of thoughts is mentioned. The participants learn to challenge unfunctional thoughts and generate alternative explanations. Also, exercises on excessive worry are applied.

Session 7 - Behaviors: the role of behaviors and the things that can/cannot be controlled are discussed.

Session 8 - Evaluation & Maintaining Accomplishments: includes a review of what has been learnt during the group therapy and an evaluation on maintaining the accomplishments.

Session 9 - Follow-up session: one month later.

Intervention Type: OTHER

Client-centered Supportive Therapy

Client-entered therapy provides a non-directive supportive environment for the participants, that includes reflective listening and nonjudgmental and empathic communication. In this group, no CBT intervention will be applied. Through the supportive and non-directive environment, only the effect of relationship will be investigated as a common factor in psychotherapy.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Being diagnosed with at least one of the following disorders in the pre-interview (SCID 5 interview for diagnosis): generalized anxiety disorder (GAD), panic disorder (PD), social anxiety disorder (SAD) or anxiety disorder not otherwise specified (NOS).

Exclusion Criteria

• Active substance use or having a psychiatric history related to substance use
• Having a co-diagnosis of psychotic disorders or bipolar disorders
• Receiving active psychotherapy support
• Being not graduated from primary school

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ibn Haldun University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iclal AYDIN, MA

Role: PRINCIPAL_INVESTIGATOR

İbn Haldun University

Locations

Iclal AYDIN

Zeyti̇nburnu, Istanbul, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Iclal AYDIN, MA

Role: CONTACT

iclalaydin@stu.ihu.edu.tr

00905353746285

Facility Contacts

Iclal AYDIN, MA

Role: primary

iclalaydin@stu.ihu.edu.tr

00905353746285

Other Identifiers

E-71395021-050.06.04-35012

Identifier Type: -

Identifier Source: org_study_id