Clinical trial NCT06422728: The Effectiveness of Transdiagnostic CBT Protocol on Anxiety Disorders
Official title: The Effectiveness of Transdiagnostic CBT Protocol on Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Social Anxiety Disorder
Generalized Anxiety Disorder
Panic Disorder
Anxiety Disorder NOS
Keywords: transdiagnostic approach
unified protocol,
anxiety disorders
CBT
cognitive behavioral therapy
Lead sponsor: Ibn Haldun University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will search the effectiveness of the unified protocol on anxiety disorders. For this purpose, there will be an intervention group (unified protocol will be applied) and a control group. The participants will be assigned randomly to the groups.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Anxiety
timeFrame: pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test)
measure: Distress Tolerance
timeFrame: pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test)
measure: Intolerance of Uncertainty
timeFrame: pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test)
measure: Worry
timeFrame: pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test)
measure: Metacognition
timeFrame: pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test)
measure: Depression
timeFrame: pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test)
Secondary outcomes:
Other outcomes:
Locations:
city: Zeyti̇nburnu
country: Turkey
facility: Iclal AYDIN
state: İstanbul
Study officials:
affiliation: İbn Haldun University
name: Iclal AYDIN, MA
role: PRINCIPAL_INVESTIGATOR
References: