The Effectiveness of Transdiagnostic CBT Protocol on Anxiety Disorders

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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'.

Eligibility

Primary outcome measure(s)

• Anxiety — 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.
• Distress Tolerance — 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.
• Intolerance of Uncertainty — 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.
• Worry — 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.
• Metacognition — 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.
• Depression — 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.

Trial sites (1)

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