The Effectiveness of Transdiagnostic CBT Protocol on Anxiety Disorders

NCT06422728 | Recruiting

• 1 other identifier: E-71395021-050.06.04-35012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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'.

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

Outcome Measures

Primary Outcomes (6)

• Anxiety

  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.

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

• Distress Tolerance

  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.

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

• Intolerance of Uncertainty

  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.

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

• Worry

  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.

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

• Metacognition

  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.

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

• Depression

  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.

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

Study Arms (2)

Transdiagnostic Unified Protocol

EXPERIMENTAL

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.

Other: Unified Protocol for Anxiety Disorders

Client-Centered Supportive Therapy

ACTIVE COMPARATOR

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.

Other: Client-centered Supportive Therapy

Interventions

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.

Transdiagnostic Unified Protocol

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.

Client-Centered Supportive Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Ibn Haldun University: lead

Study Sites (1)

Iclal AYDIN

Zeyti̇nburnu, Istanbul, 34025, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Phobia, Social; Generalized Anxiety Disorder; Panic Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders

Study Officials

• Iclal AYDIN, MA

  İbn Haldun University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iclal AYDIN, MA

CONTACT

00905353746285; iclalaydin@stu.ihu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In this study, single-blind procedure will be applied to reduce biases. For this purpose, participants will be informed only about the general procedure of group therapy (e.g. general focus of the group therapy, number of sessions, duration of sessions, number of participants) but will not be informed about which intervention they receive and which group they are assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 21, 2024
• Study Start: June 20, 2024
• Primary Completion: September 1, 2024
• Study Completion: January 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)