Study on 30 Outpatients With Chronic Migraine Treated With Well-Being Therapy or With a Control Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03404336|
Recruitment Status : Not yet recruiting
First Posted : January 19, 2018
Last Update Posted : January 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Migraine||Behavioral: Well-Being Therapy Other: Control condition||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a pilot study, designed as a randomized (1:1) controlled trial, comparing WBT vs a control condition. The patients will receive a baseline assessment to confirm the diagnosis of chronic migraine, then socio-demographic information, information on pharmacological/non-pharmacological treatments, on the history of medical diseases and on the psychological status will be collected as well as the number of migraine attacks per month, the duration of migraine attacks, the occurrence of migraine exclusively with menses, and the level of disability related to migraine. Thereafter, the subjects will be randomly assigned to WBT or to a control condition. The subjects will be re-assessed at the end of session 4, 8 of treatment, at 3-month and 6-month follow-ups.|
|Masking Description:||Participants will not be informed if they will receive the WBT or the control condition. Of course, after the end of the study they will receive this information and they will be told why they were blind.|
|Official Title:||Pilot Randomized Controlled Trial to Evaluate the Efficacy of Well-Being Therapy vs a Control Condition in Chronic Migraine Patients|
|Estimated Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||May 30, 2019|
|Estimated Study Completion Date :||May 30, 2019|
Experimental: Well-being therapy
WBT will be used as the only non-pharmacological therapeutic strategy and 8 sessions will be delivered every other week with a duration of 60 minutes each. The manualized WBT will be used (Fava, 2016). Thus, the initial phase will be concerned with self-observation of psychological well-being. Once the instances of well-being will be properly recognized, the patient will be encouraged to identify thoughts, beliefs, and behaviors leading to premature interruption of well-being (intermediate phase). The final part will involve cognitive restructuring of dysfunctional dimensions of psychological well-being and meeting the challenge that optimal experiences may entail.
Behavioral: Well-Being Therapy
Session 1: identifying and setting episodes of wellbeing into situational context. Session 2: identifying interfering thoughts and behaviors. Session 3: illustrating autonomy, reflecting and practicing it. Session 4: illustrating environmental mastery, reflecting and practicing it. Session 5: illustrating positive relations with others, reflecting and practicing it. Session 6: illustrating personal growth, reflecting and practicing it. Session 7: illustrating self-acceptance, reflecting and practicing it. Session 8: illustrating purpose in life, reflecting and practicing it.
Placebo Comparator: Control condition
The control condition will include 8 be-weekly sessions based on Lifestyle and well-being National Institute for health and Care Excellence (NICE) guidelines (https://www.nice.org.uk/guidance/lifestyle-and-wellbeing) and on World Health Organization 12 steps to healthy eating (http://www.euro.who.int/en/health-topics/disease-prevention/nutrition/a-healthy-lifestyle). These sessions will inform participants about well-being and which lifestyles can influence it.
Other: Control condition
Session 1: illustrating the concept of lifestyle and well-being. Session 2 and session 3: illustrating healthy eating and steps to healthy eating. Session 4: illustrating physical exercise and how it promotes health. Session 5: illustrating smoking and tobacco and how they can damage health. Session 6: illustrating alcohol and how it can damage health. Session 7: illustrating drugs misuse and how it can damage health. Session 8: illustrating sexual health. No access to specific WBT ingredients will be allowed.
- disability due to migraine [ Time Frame: from baseline to 3-month follow up ]level of disability due to migraine assessed via the Migraine Disability Assessment Score (score from 0 to >21, for total score > 6 disability is clinically relevant)
- frequency of migraine attacks [ Time Frame: from baseline to 3-month follow up ]frequency of migraine attacks assessed via a daily self-report headache diary (higher the frequency, higher the severity of migraine)
- duration of migraine attacks [ Time Frame: from baseline to 3-month follow up ]duration of migraine attacks assessed via a daily self-report headache diary (higher the duration, higher the severity of migraine)
- intensity of migraine attacks [ Time Frame: from baseline to 3-month follow up ]intensity of migraine attacks assessed via a daily self-report headache diary (higher the intensity, higher the severity of migraine)
- level of anxiety and depression [ Time Frame: from baseline to 3-month follow up ]the level of anxiety and depression will be assessed via the Symptom Questionnaire (total score from 0 to 92, higher is the total score and worse is the symptomatology)
- level of psychological well-being [ Time Frame: from baseline to 3-month follow up ]assessed via the World Health Organization-Five Well-Being Index (WHO 5) (total score from 0 to 25, higher total score means higher quality of life)
- level of psychological well-being [ Time Frame: from baseline to 3-month follow up ]assessed via Psychological Well-Being Questionnaire (PWB) (total score from 84 to 504, higher score corresponds to higher psychological well-being)
- the level of euthymia [ Time Frame: from baseline to 3-month follow up ]the level of euthymia will be assessed via the euthymia scale (total score from 0 to 10, higher score corresponds to higher level of euthymia)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404336
|Contact: Fiammetta COSCI, Prof.||0552755066 ext firstname.lastname@example.org|
|Fiammetta COSCI||Not yet recruiting|
|Florence, Italy, 50135|
|Contact: Fiammetta COSCI, MD, PhD 0552755066 ext 0039 email@example.com|