Chronic Migraine, Migraine
Conditions
Keywords
Introvision: mental and emotional self-regulation technique, Mindfulness, perception technique, Migraine
Brief summary
To evaluate the effect of Introvision, a mental and emotional self-regulation-technique developed by Angelika C. Wager, as migraine preventative compared to a waiting list group.
Detailed description
Randomized, single-center, waiting-list control group study: Introvision as preventative in Migraine Randomized, single center, waiting-list group control study to evaluate the effect of Introvison, a mental and emotional self regulation method to reduce headache days in patients with migraine, migraine and tension type headache and chronic migraine. The number of headache days 3 months after completion of the last session of Introvision will be compared with the number of headache days of the waiting list group in the month before the course to learn Introvision.
Interventions
BEHAVIORALIntrovision: mental and emotional self-regulation
Participants learn Introvision
Sponsors
University of Hamburg-Eppendorf
Introvision e.V
Ludwig-Maximilians - University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
waiting list control study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Episodic migraine with at least 5 headache days per month, episodic migraine and tension type headache with at least 5 migraine headache days per month, chronic migraine * Stable prophylactic headache medication * Stable non-medication headache prophylaxis (sports, relaxation techniques, …) * Informed consent
Exclusion criteria
* Other causes of headache, symptomatic headaches * Other primary headaches such as Cluster headache, trigeminal neuralgia, idiopathic facial pain, new daily persistent headache * Severe depression (more than 13 points in the Beck Depression inventory fast screen (BDI-FS) * Drug - or alcohol abuse * Non-compliance, especially significant missing entries in the headache diaries * Active psychosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Headache Days Per Month | approximately 4 months, as the course to learn Introvision and the three individual sessions will take nearly 2 months to be completed, and headaches per month will be assessed in the month 3 months after the last session of Introvision. | The number of headache days per month 3 months after completion of the last session of Introvision will be compared with the number of headache days of the waiting list group in the month before the course to learn Introvision. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Headache Days Per Month in Pooled Groups Analysis Before and 3 Months After Introvision as Parameter for the Efficacy of Introvision | approximately 5-6 months | number of headache days per months in pooled groups analysis before and 3 months after Introvision, measured with the number of headache days per months as in the primary outcome measure, but both groups together compared before Introvision and three months after the last session |
| Headache Management Self-efficacy Scale-German-short Form (HMSE-G-SF) | approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session | The headache specific self-efficacy scale (Headache Management Self-efficacy Scale-German-short form: HMSE-G-SF) consists of 6 items with a 7-point response scale which ranges from 1 (strongly disagree) to 7 (strongly agree).The 6 items measure self-efficacy beliefs, for instance: There are things I can do to alleviate the headache. The scores for each of the six items are combined to compute the total score, that may range from 6 to 42 points. A higher score indicates a stronger self-efficacy in headache management. It is measured before Introvision and three month after the last session of Introvision. |
| Headache-Impact Test 6, HIT-6 | approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session | Impact of headache (Headache-Impact Test 6, HIT-6), compared three months after the last session of Introvision to before introvision. The total score may range from 6 to 78 points, a higher score indicates a higher impact of headaches on daily activities. |
| Overall Satisfaction of Patients | approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session | Patients will be asked whether they would recommend Introvision for headache patients and can choose between yes or no. The number of patients responding yes is reported. |
| Headache Intensity | approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session | Headache intensity rated by the patients themselves with a scale in the headache diary: weak (=1) , moderate (=2), severe (=3) headache. Scores may range from 1 to 3. Average headache intensity of the attacks per months will be compared three months after the last session of Introvision compared to the values before Introvison. |
| Acute Medication Per Month | approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session | The number of days with acute medication against migraine attacks/headache per month 3 months after completion of the last session of Introvision will be compared with the number of days with acute medication per month before Introvision. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Influence of Side of Headache on Outcome as Exploratory Outcome Measure | approximately 5-6 months | Do patients with a predominantly left-sided headache show a greater reduction of headache days per month 3 months after completion of the last session of Introvision compared to patients with predominantely right-sided headache? |
| Influence of Frequency of Exercises as Exploratory Outcome Measure | approximately 5-6 months | Influence of frequency of self-regulation exercises per week on outcome, measured with reduction of headache days per month before and after Introvision. The frequency of self-regulation exercises is documented by the patients themselves on average in a month in the headache diary, with a three categories scale: 0 exercise per week; 1-3 exercises per week, more than 4 exercises per week. |
| Patients' Mastery of Introvision as Exploratory Outcome Measure | approximately 5-6 months | investigators' estimation of patients' mastery of introvision,. Evaluated by the investigator after the last session in a three category scale: good mastery, moderate mastery, insufficient mastery. Does the mastery of introvision influence the reduction of headache days per month? |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-waiting List Group Intervention: Introvision: mental and emotional self-regulation
Introvision: mental and emotional self-regulation: Participants learn Introvision | 35 |
| Waiting List Group Intervention: Introvision: mental and emotional self-regulation
Introvision is teached to participants of the waiting-list group at least 6 weaks or more after first group
Introvision: mental and emotional self-regulation: Participants learn Introvision | 37 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | discontinued | 5 | 1 |
| Overall Study | Lost to Follow-up | 8 | 6 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Non-waiting List Group | Total | Waiting List Group |
|---|---|---|---|
| Age, Continuous | 44.3 years STANDARD_DEVIATION 12 | 42.9 years STANDARD_DEVIATION 11.3 | 41.5 years STANDARD_DEVIATION 10.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 72 Participants | 37 Participants |
| Region of Enrollment Germany | 35 participants | 72 participants | 37 participants |
| Sex: Female, Male Female | 35 Participants | 67 Participants | 32 Participants |
| Sex: Female, Male Male | 0 Participants | 5 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 37 |
| other Total, other adverse events | 1 / 51 | 0 / 37 |
| serious Total, serious adverse events | 0 / 51 | 0 / 37 |
Outcome results
Primary
Number of Headache Days Per Month
The number of headache days per month 3 months after completion of the last session of Introvision will be compared with the number of headache days of the waiting list group in the month before the course to learn Introvision.
Time frame: approximately 4 months, as the course to learn Introvision and the three individual sessions will take nearly 2 months to be completed, and headaches per month will be assessed in the month 3 months after the last session of Introvision.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-waiting List Group | Number of Headache Days Per Month | 10.6 days per month | Standard Deviation 7.7 |
| Waiting List Group | Number of Headache Days Per Month | 10.9 days per month | Standard Deviation 6.3 |
p-value: 0.63Wilcoxon (Mann-Whitney)
Comparison: pooled comparison of the participants of the non-waiting list and the waiting list before and after Introvisionp-value: 0.003Wilcoxon (Mann-Whitney)
Secondary
Acute Medication Per Month
The number of days with acute medication against migraine attacks/headache per month 3 months after completion of the last session of Introvision will be compared with the number of days with acute medication per month before Introvision.
Time frame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-waiting List Group | Acute Medication Per Month | 6.3 days per month | Standard Deviation 3.6 |
| Waiting List Group | Acute Medication Per Month | 5.0 days per month | Standard Deviation 3.7 |
p-value: 0.004Wilcoxon (Mann-Whitney)
Secondary
Headache-Impact Test 6, HIT-6
Impact of headache (Headache-Impact Test 6, HIT-6), compared three months after the last session of Introvision to before introvision. The total score may range from 6 to 78 points, a higher score indicates a higher impact of headaches on daily activities.
Time frame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-waiting List Group | Headache-Impact Test 6, HIT-6 | 64.3 score on a scale | Standard Deviation 4.2 |
| Waiting List Group | Headache-Impact Test 6, HIT-6 | 61.4 score on a scale | Standard Deviation 5.9 |
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
Headache Intensity
Headache intensity rated by the patients themselves with a scale in the headache diary: weak (=1) , moderate (=2), severe (=3) headache. Scores may range from 1 to 3. Average headache intensity of the attacks per months will be compared three months after the last session of Introvision compared to the values before Introvison.
Time frame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-waiting List Group | Headache Intensity | 2.0 units on a scale | Standard Deviation 0.5 |
| Waiting List Group | Headache Intensity | 2.0 units on a scale | Standard Deviation 0.5 |
Secondary
Headache Management Self-efficacy Scale-German-short Form (HMSE-G-SF)
The headache specific self-efficacy scale (Headache Management Self-efficacy Scale-German-short form: HMSE-G-SF) consists of 6 items with a 7-point response scale which ranges from 1 (strongly disagree) to 7 (strongly agree).The 6 items measure self-efficacy beliefs, for instance: There are things I can do to alleviate the headache. The scores for each of the six items are combined to compute the total score, that may range from 6 to 42 points. A higher score indicates a stronger self-efficacy in headache management. It is measured before Introvision and three month after the last session of Introvision.
Time frame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-waiting List Group | Headache Management Self-efficacy Scale-German-short Form (HMSE-G-SF) | 21.7 score on a scale | Standard Deviation 7.7 |
| Waiting List Group | Headache Management Self-efficacy Scale-German-short Form (HMSE-G-SF) | 26.2 score on a scale | Standard Deviation 6 |
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
Number of Headache Days Per Month in Pooled Groups Analysis Before and 3 Months After Introvision as Parameter for the Efficacy of Introvision
number of headache days per months in pooled groups analysis before and 3 months after Introvision, measured with the number of headache days per months as in the primary outcome measure, but both groups together compared before Introvision and three months after the last session
Time frame: approximately 5-6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-waiting List Group | Number of Headache Days Per Month in Pooled Groups Analysis Before and 3 Months After Introvision as Parameter for the Efficacy of Introvision | 11.7 days per month | Standard Deviation 6.5 |
| Waiting List Group | Number of Headache Days Per Month in Pooled Groups Analysis Before and 3 Months After Introvision as Parameter for the Efficacy of Introvision | 9.8 days per month | Standard Deviation 7 |
p-value: 0.003Wilcoxon (Mann-Whitney)
Secondary
Overall Satisfaction of Patients
Patients will be asked whether they would recommend Introvision for headache patients and can choose between yes or no. The number of patients responding yes is reported.
Time frame: approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session
Population: 97% of participants recommended Introvision for migraine patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-waiting List Group | Overall Satisfaction of Patients | 45 Participants |
Other Pre-specified
Influence of Frequency of Exercises as Exploratory Outcome Measure
Influence of frequency of self-regulation exercises per week on outcome, measured with reduction of headache days per month before and after Introvision. The frequency of self-regulation exercises is documented by the patients themselves on average in a month in the headache diary, with a three categories scale: 0 exercise per week; 1-3 exercises per week, more than 4 exercises per week.
Time frame: approximately 5-6 months
Other Pre-specified
Influence of Side of Headache on Outcome as Exploratory Outcome Measure
Do patients with a predominantly left-sided headache show a greater reduction of headache days per month 3 months after completion of the last session of Introvision compared to patients with predominantely right-sided headache?
Time frame: approximately 5-6 months
Population: Headache days before and after Introvision in patients with a) predominantly left-sided headache, b) predominantly right-sided headache, c) bilateral or equally alterating headache
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-waiting List Group | Influence of Side of Headache on Outcome as Exploratory Outcome Measure | 13.9 days per month | Standard Deviation 5.7 |
| Waiting List Group | Influence of Side of Headache on Outcome as Exploratory Outcome Measure | 10.1 days per month | Standard Deviation 3.6 |
| Patients With Predominantly Right-sided Headache Before Introvision | Influence of Side of Headache on Outcome as Exploratory Outcome Measure | 9.9 days per month | Standard Deviation 4.5 |
| Patients With Predominantly Right-sided Headache After Introvision | Influence of Side of Headache on Outcome as Exploratory Outcome Measure | 9.1 days per month | Standard Deviation 4.9 |
| Patients With Bilateral or Alternating Headache Before Introvision | Influence of Side of Headache on Outcome as Exploratory Outcome Measure | 11.7 days per month | Standard Deviation 7.3 |
| Patients With Bilateral or Alternating Headaches After Introvision | Influence of Side of Headache on Outcome as Exploratory Outcome Measure | 10.4 days per month | Standard Deviation 9.4 |
p-value: 0.04Wilcoxon (Mann-Whitney)
p-value: 0.25Wilcoxon (Mann-Whitney)
p-value: 0.02Wilcoxon (Mann-Whitney)
Other Pre-specified
Patients' Mastery of Introvision as Exploratory Outcome Measure
investigators' estimation of patients' mastery of introvision,. Evaluated by the investigator after the last session in a three category scale: good mastery, moderate mastery, insufficient mastery. Does the mastery of introvision influence the reduction of headache days per month?
Time frame: approximately 5-6 months