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NCT Number: NCT06422728

The Effectiveness of Transdiagnostic CBT Protocol on Anxiety Disorders

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'.

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Key information

Conditions

Anxiety Disorders Anxiety Disorder NOS Generalized Anxiety Disorder Mental Disorders Panic Disorder Phobia, Social Phobic Disorders Social Anxiety Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Iclal AYDIN

Zeyti̇nburnu, Istanbul, 34025, Turkey (Türkiye)

Location status: Recruiting

Location contact

Iclal AYDIN, MA

CONTACT

[email protected]

00905353746285

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Unified Protocol for Anxiety Disorders

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

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.

Primary outcomes

  1. Anxiety

    Time frame: pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test)

    Generalized Anxiety Disorder-7 (GAD-7) scale will be used to measure anxiety level. GAD-7 is a self-report scale consisting of 7 items. It is a 4-point Likert type scale. Items are scored between 0 (Not at all) and 3 (Nearly every day). Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety. In the total score, the cut-off score for GAD diagnosis is 10.

  2. Distress Tolerance

    Time frame: pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test)

    Distress Tolerance Scale (DTS) scale will be used to measure distress tolerance level. DTS consists of a total of 15 items. Each item is rated on a 5-point Likert scale range from 1 (Strongly disagree) to 5 (Strongly disagree). A low total score indicates low distress tolerance level.

  3. Intolerance of Uncertainty

    Time frame: pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test)

    Intolerance of Uncertainty Scale (IUS) - Short Version will be used to measure the level of intolerance of uncertainty. IUS-12 is a self-report scale consisting of 12 items in total. It is a 5-point Likert scale. Each item is scored between 1 (not at all characteristic of me) to 5 (entirely characteristic of me). A high total score indicates a high level of intolerance to uncertainty.

  4. Worry

    Time frame: pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test)

    Penn State Worry Questionnaire will be used to measure the level of worry. PSWQ is a self-report scale with a 5-point Likert-type, consisting of a total of 16 items. Scale items are scored between 1 (Not at all typical) - 5 (Very typical of me). An increase in the PSWQ total score indicates a high level of worry.

  5. Metacognition

    Time frame: pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test)

    Metacognition Questionnaire-30 Short Form will be used to measure metacognitive beliefs. MCQ-30, consisting of a total of 30 items, has a 4-point Likert-type scale. Each item is scored between 1 (Do not agree) and 4 (Agree very much). An increase in scale scores indicates an increase in pathological metacognitive activity.

  6. Depression

    Time frame: pre-test (baseline at Week 1), post-test (at Week 8), follow-up test (1 month after post-test)

    Patient Health Questionnaire-9 (PHQ-9) will be used to measure the level of depression. PHQ-9 consists of 9 questions which is a 4-point Likert type scale. Each item is scored between 0 (Not at all) - 3 (Nearly every day). As the total score increases, the severity of depression increases.

Study contacts

Contact information is provided by the study sponsor or research team.

Iclal AYDIN, MA

CONTACT

[email protected]

00905353746285

Sponsors and collaborators

Lead sponsor

Ibn Haldun University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 21, 2024
Registry last updated
Sep 19, 2024

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

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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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