CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Trans-diagnostic cognitive-behavioral therapy +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03701477
NCT03701477N/ACompleted

Evaluation of the Efficacy of Trans-diagnostic Cognitive-behavioral Therapy on Controlling and Reducing Headache and Associated Symptoms Among Migrainous Patients

Isfahan University of Medical Sciences·interventional·Posted Oct 10, 2018·Updated May 16, 2024

In Brief

A clinical study evaluating Trans-diagnostic cognitive-behavioral therapy and General relaxation/stress management therapeutic session for Migraine. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Migraine headache is one of the disabling conditions that may be associated with decreased quality of life, anxiety and depression. Currently, therapeutic approach to migraine is mostly based on prophylactic and acute phase medication therapy. Some investigators consider migraine a biopsychosocial condition which means that psychological therapies, such as cognitive-behavioral therapy and relaxation, may be efficient in controlling the disease. According to previous studies, cognitive therapies, including cognitive-behavioral therapy, have been efficient in decreasing frequency and severity of migraine, however, there are some challenges in applying these kind of interventions: the expenses; presence of multiple commodities that may lead to confusion and bewilderment for both therapist and patient; small number of trained psychologists for this intervention. The trans-diagnostic approach, however, can facilitate some challenges with the previous method. Since it is not focused on a single condition, trained psychologists with this approach can apply it for a wide range of conditions, including migraine. Also, the trans-diagnostic approach leads to lower chances of confusion and bewilderment for therapist and patients. The trans-diagnostic approach focuses on therapeutic modules instead of constant similar therapeutic models. The five cores of trans-diagnostic approach are emotional awareness, cognitive flexibility, recognizing and preventing emotion avoidance and maladaptive emotion driven behaviors, awareness and tolerance of emotion-related physical conditions, and introceptive and situation-based emotion-focused exposure. This method was first designed to replace cognitive-behavioral therapy for emotional disorders, due to its feasibility and applicability. The trans-diagnostic approach has been investigated by several researchers so far, however, most of those researches evaluate the efficacy of the technique on psychiatric disorders. It has also been investigated for treatment of headaches in adolescents. But no other study on other clinical problems or migraine has been conducted. Considering the high rates of comorbid anxiety and depressive symptoms in migrainous patients and the feasibility and efficacy of trans-diagnostic cognitive-behavioral therapy in other conditions, we aimed to evaluate its efficacy on controlling headache and related symptoms among migrainous patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesIran
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 10, 2018
Enrollment StartOct 1, 2018
Primary CompletionApr 30, 2019
Study CompletionSep 30, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.7 years ago

Interventions

Trans-diagnostic cognitive-behavioral therapybehavioral

10 therapeutic sessions hold in groups of 5-10 individuals. Details about each session: Session 1: Establishing rapport, psychoeducation; Session 2: Relaxation, hierarchy development; Session 3: Identifying automatic negative thoughts, guided imaginary; Session 4: Cognitive restructuring; Session 5: Problem solving skills training, distraction; Session 6: Exposure-based procedures, cognitive restructuring; Session 7-9: Advanced cognitive restructuring, stress management, assertiveness skills training, preparation for termination phase; Session 10: Relapse prevention, termination

General relaxation/stress management therapeutic sessionbehavioral

Patients will attend a 3-hour meeting in which basic techniques of relaxation and stress management will be discussed.