Trial Outcomes & Findings for Introvision for Migraine and Headaches (NCT NCT03507400)

NCT ID: NCT03507400

Last Updated: 2025-04-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 72 participants
• Primary outcome timeframe: 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.
• Results posted on: 2025-04-18

Participant Flow

Participant milestones

Measure	Non-waiting List Group Intervention: Introvision: mental and emotional self-regulation Introvision: mental and emotional self-regulation: Participants learn Introvision	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
Overall Study STARTED	35	37
Overall Study COMPLETED	22	29
Overall Study NOT COMPLETED	13	8

Reasons for withdrawal

Measure	Non-waiting List Group Intervention: Introvision: mental and emotional self-regulation Introvision: mental and emotional self-regulation: Participants learn Introvision	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
Overall Study discontinued	5	1
Overall Study Lost to Follow-up	8	6
Overall Study Protocol Violation	0	1

Baseline Characteristics

Introvision for Migraine and Headaches

Baseline characteristics by cohort

Measure	Non-waiting List Group n=35 Participants Intervention: Introvision: mental and emotional self-regulation Introvision: mental and emotional self-regulation: Participants learn Introvision	Waiting List Group n=37 Participants 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	Total n=72 Participants Total of all reporting groups
Age, Continuous	44.3 years STANDARD_DEVIATION 12.0 • n=5 Participants	41.5 years STANDARD_DEVIATION 10.7 • n=7 Participants	42.9 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	32 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants	37 Participants n=7 Participants	72 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Germany	35 participants n=5 Participants	37 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Non-waiting List Group n=22 Participants Intervention: Introvision: mental and emotional self-regulation Introvision: mental and emotional self-regulation: Participants learn Introvision	Waiting List Group n=29 Participants 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	Patients With Predominantly Right-sided Headache Before Introvision Patients with headache predominantly (estimated more than 70%) on the right side before introvision	Patients With Predominantly Right-sided Headache After Introvision Patients with headache predominantly (estimated more than 70%) on the right side after introvision	Patients With Bilateral or Alternating Headache Before Introvision Patients with bilateral headache or headaches that alternate both sides equally before introvison	Patients With Bilateral or Alternating Headaches After Introvision Patients with bilateral headache or headaches that alternate both sides equally after introvison
Number of Headache Days Per Month	10.6 days per month Standard Deviation 7.7	10.9 days per month Standard Deviation 6.3	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Non-waiting List Group n=49 Participants Intervention: Introvision: mental and emotional self-regulation Introvision: mental and emotional self-regulation: Participants learn Introvision	Waiting List Group n=49 Participants 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	Patients With Predominantly Right-sided Headache Before Introvision Patients with headache predominantly (estimated more than 70%) on the right side before introvision	Patients With Predominantly Right-sided Headache After Introvision Patients with headache predominantly (estimated more than 70%) on the right side after introvision	Patients With Bilateral or Alternating Headache Before Introvision Patients with bilateral headache or headaches that alternate both sides equally before introvison	Patients With Bilateral or Alternating Headaches After Introvision Patients with bilateral headache or headaches that alternate both sides equally after introvison
Headache Intensity	2.0 units on a scale Standard Deviation 0.5	2.0 units on a scale Standard Deviation 0.5	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Non-waiting List Group n=47 Participants Intervention: Introvision: mental and emotional self-regulation Introvision: mental and emotional self-regulation: Participants learn Introvision	Waiting List Group n=47 Participants 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	Patients With Predominantly Right-sided Headache Before Introvision Patients with headache predominantly (estimated more than 70%) on the right side before introvision	Patients With Predominantly Right-sided Headache After Introvision Patients with headache predominantly (estimated more than 70%) on the right side after introvision	Patients With Bilateral or Alternating Headache Before Introvision Patients with bilateral headache or headaches that alternate both sides equally before introvison	Patients With Bilateral or Alternating Headaches After Introvision Patients with bilateral headache or headaches that alternate both sides equally after introvison
Acute Medication Per Month	6.3 days per month Standard Deviation 3.6	5.0 days per month Standard Deviation 3.7	—	—	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Non-waiting List Group n=49 Participants Intervention: Introvision: mental and emotional self-regulation Introvision: mental and emotional self-regulation: Participants learn Introvision	Waiting List Group n=49 Participants 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	Patients With Predominantly Right-sided Headache Before Introvision Patients with headache predominantly (estimated more than 70%) on the right side before introvision	Patients With Predominantly Right-sided Headache After Introvision Patients with headache predominantly (estimated more than 70%) on the right side after introvision	Patients With Bilateral or Alternating Headache Before Introvision Patients with bilateral headache or headaches that alternate both sides equally before introvison	Patients With Bilateral or Alternating Headaches After Introvision Patients with bilateral headache or headaches that alternate both sides equally after introvison
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	9.8 days per month Standard Deviation 7.0	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Non-waiting List Group n=46 Participants Intervention: Introvision: mental and emotional self-regulation Introvision: mental and emotional self-regulation: Participants learn Introvision	Waiting List Group n=46 Participants 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	Patients With Predominantly Right-sided Headache Before Introvision Patients with headache predominantly (estimated more than 70%) on the right side before introvision	Patients With Predominantly Right-sided Headache After Introvision Patients with headache predominantly (estimated more than 70%) on the right side after introvision	Patients With Bilateral or Alternating Headache Before Introvision Patients with bilateral headache or headaches that alternate both sides equally before introvison	Patients With Bilateral or Alternating Headaches After Introvision Patients with bilateral headache or headaches that alternate both sides equally after introvison
Headache Management Self-efficacy Scale-German-short Form (HMSE-G-SF)	21.7 score on a scale Standard Deviation 7.7	26.2 score on a scale Standard Deviation 6.0	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Non-waiting List Group n=47 Participants Intervention: Introvision: mental and emotional self-regulation Introvision: mental and emotional self-regulation: Participants learn Introvision	Waiting List Group n=47 Participants 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	Patients With Predominantly Right-sided Headache Before Introvision Patients with headache predominantly (estimated more than 70%) on the right side before introvision	Patients With Predominantly Right-sided Headache After Introvision Patients with headache predominantly (estimated more than 70%) on the right side after introvision	Patients With Bilateral or Alternating Headache Before Introvision Patients with bilateral headache or headaches that alternate both sides equally before introvison	Patients With Bilateral or Alternating Headaches After Introvision Patients with bilateral headache or headaches that alternate both sides equally after introvison
Headache-Impact Test 6, HIT-6	64.3 score on a scale Standard Deviation 4.2	61.4 score on a scale Standard Deviation 5.9	—	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Non-waiting List Group n=46 Participants Intervention: Introvision: mental and emotional self-regulation Introvision: mental and emotional self-regulation: Participants learn Introvision	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	Patients With Predominantly Right-sided Headache Before Introvision Patients with headache predominantly (estimated more than 70%) on the right side before introvision	Patients With Predominantly Right-sided Headache After Introvision Patients with headache predominantly (estimated more than 70%) on the right side after introvision	Patients With Bilateral or Alternating Headache Before Introvision Patients with bilateral headache or headaches that alternate both sides equally before introvison	Patients With Bilateral or Alternating Headaches After Introvision Patients with bilateral headache or headaches that alternate both sides equally after introvison
Overall Satisfaction of Patients	45 Participants	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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?

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

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?

Outcome measures

Measure	Non-waiting List Group n=12 Participants Intervention: Introvision: mental and emotional self-regulation Introvision: mental and emotional self-regulation: Participants learn Introvision	Waiting List Group n=12 Participants 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	Patients With Predominantly Right-sided Headache Before Introvision n=16 Participants Patients with headache predominantly (estimated more than 70%) on the right side before introvision	Patients With Predominantly Right-sided Headache After Introvision n=16 Participants Patients with headache predominantly (estimated more than 70%) on the right side after introvision	Patients With Bilateral or Alternating Headache Before Introvision n=23 Participants Patients with bilateral headache or headaches that alternate both sides equally before introvison	Patients With Bilateral or Alternating Headaches After Introvision n=23 Participants Patients with bilateral headache or headaches that alternate both sides equally after introvison
Influence of Side of Headache on Outcome as Exploratory Outcome Measure	13.9 days per month Standard Deviation 5.7	10.1 days per month Standard Deviation 3.6	9.9 days per month Standard Deviation 4.5	9.1 days per month Standard Deviation 4.9	11.7 days per month Standard Deviation 7.3	10.4 days per month Standard Deviation 9.4

Adverse Events

Introvision Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Waiting List Group Before Introvision

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Introvision Group n=51 participants at risk Intervention: Introvision: mental and emotional self-regulation Introvision: mental and emotional self-regulation: Participants learn Introvision	Waiting List Group Before Introvision n=37 participants at risk 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
Cardiac disorders Tachycardia self-limiting during a SAP (stating attentive perception) exercise	2.0% 1/51 • Number of events 1 • Start of group sessions till forth month after last introvision session, when collecting the data after the last Introvision session (diaries, questionnaires, question for recommendations) participants were asked whether they experienced any adverse events.	0.00% 0/37 • Start of group sessions till forth month after last introvision session, when collecting the data after the last Introvision session (diaries, questionnaires, question for recommendations) participants were asked whether they experienced any adverse events.

Additional Information

Dr. Monika Empl

Practice for Neurology and Ludwigs-Maximilians-Universitiy Munich

Phone: +4989500598710

Email: dr.empl@dr-empl-neurologie.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place