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Clinical Trial NCT06422728 for Anxiety Disorders, Social Anxiety Disorder, Generalized Anxiety Disorder, Panic Disorder, Anxiety Disorder NOS is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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The Effectiveness of Transdiagnostic CBT Protocol on Anxiety Disorders 60
Clinical Trial NCT06422728 is an interventional study for Anxiety Disorders, Social Anxiety Disorder, Generalized Anxiety Disorder, Panic Disorder, Anxiety Disorder NOS that is recruiting. It started on June 20, 2024 with plans to enroll 60 participants. Led by Ibn Haldun University, it is expected to complete by January 1, 2025. The latest data from ClinicalTrials.gov was last updated on September 19, 2024.
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 th...Show More
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 ...Show More
Official Title
The Effectiveness of Transdiagnostic CBT Protocol on Anxiety Disorders
Conditions
Anxiety DisordersSocial Anxiety DisorderGeneralized Anxiety DisorderPanic DisorderAnxiety Disorder NOSOther Study IDs
- E-71395021-050.06.04-35012
NCT ID Number
Start Date (Actual)
2024-06-20
Last Update Posted
2024-09-19
Completion Date (Estimated)
2025-01
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
transdiagnostic approach
unified protocol,
anxiety disorders
CBT
cognitive behavioral therapy
unified protocol,
anxiety disorders
CBT
cognitive behavioral therapy
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalTransdiagnostic 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. | 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...Show More |
Active ComparatorClient-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. | 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. |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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).
- 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
Ibn Haldun UniversityStudy Central Contact
Contact: Iclal AYDIN, MA, 00905353746285, [email protected]
1 Study Locations in 1 Countries
Istanbul
Iclal AYDIN, Zeyti̇nburnu, Istanbul, 34025, Turkey (Türkiye)
Iclal AYDIN, MA, Contact, 00905353746285, [email protected]
Recruiting