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Brief Behavioral Intervention for Comorbid Migraine and Depression (ACT-IM)

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ClinicalTrials.gov Identifier: NCT01775852
Recruitment Status : Completed
First Posted : January 25, 2013
Results First Posted : September 17, 2015
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Lilian N. Dindo, University of Iowa

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Migraine
Depression
Intervention Behavioral: ACT-IM
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ACT-IM Waitlist/Treatment as Usual
Hide Arm/Group Description

The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.

ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations.

The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
Period Title: Overall Study
Started 31 14
Completed 31 13
Not Completed 0 1
Arm/Group Title ACT-IM Waitlist/Treatment as Usual Total
Hide Arm/Group Description

The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.

ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations.

The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop. Total of all reporting groups
Overall Number of Baseline Participants 31 14 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 14 participants 45 participants
32.5  (13.3) 33.5  (12.9) 33  (13.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 14 participants 45 participants
Female
30
  96.8%
12
  85.7%
42
  93.3%
Male
1
   3.2%
2
  14.3%
3
   6.7%
1.Primary Outcome
Title Mean Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 12 Week Follow-up
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The HAM-D is a structured clinical interview for assessing depression severity. Outcome measure will be change from Baseline in Hamilton Depression Rating Scale at 12 week (3 month) follow-up from baseline.

Measure is scored by adding individual items and attaining an overall severity score. Scores range from 0 to 53, with higher values signifying a higher level of depression severity (and thus a worse outcome). A score of 0–7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.

Time Frame 12 week change from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACT-IM Waitlist/Treatment as Usual
Hide Arm/Group Description:

The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.

ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations.

The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
Overall Number of Participants Analyzed 31 14
Mean (Standard Error)
Unit of Measure: units on a scale
-15.1  (1.6) -4.3  (2.5)
2.Secondary Outcome
Title Mean Change Score in HDI (Headache Disability Inventory) From Baseline to 12 Weeks.
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The HDI is useful in assessing the impact of headache, and its treatment, on daily living. 25 self-report items are rated with answers as "Yes" (4 points), "Sometimes" (2 Points), and "No" (0 points). All items are then added together to create an overall score which can range from 0 (no impact), to 100 (severe impact) of headache on daily life.

A 29 point change (95% confidence interval) or greater in the total score from test to retest must occur before the change can be attributed to treatment effects.

Time Frame 12 week change from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACT-IM Waitlist/Treatment as Usual
Hide Arm/Group Description:

The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.

ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations.

The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
Overall Number of Participants Analyzed 31 14
Mean (Standard Error)
Unit of Measure: units on a scale
-27.9  (3.4) -10.7  (5.2)
3.Secondary Outcome
Title Mean Change on Short Form Health Survey (SF-36) From Baseline to 12 Week Follow-up.
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The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.

The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Time Frame Change at 12 week follow-up from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACT-IM Waitlist/Treatment as Usual
Hide Arm/Group Description:

The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.

ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations.

The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
Overall Number of Participants Analyzed 31 14
Mean (Standard Error)
Unit of Measure: units on a scale
17.0  (2.5) 7.7  (3.8)
4.Secondary Outcome
Title Mean Change of World Health Organization Disability Assessment (WHO-DAS) From Baseline to 12-week Follow up.
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The WHODAS contains 36 items on functioning and disability with a recall period of 30 days covering 7 domains: Understanding and Communicating (6 items), Getting around (5 items), Self-care (4 items), Getting along with others (5 items), Life activities: household (4 items), Life activities: work/school (4 items), and Participation in society (8 items). Response options go from 1 (no difficulty) to 5 (extreme difficulty or can not do).

WHODAS domain scores are computed for each domain by adding the item responses together. A global score is then computed by summing all domains together, and transforming them into a range from 0 to 100, with higher scores indicating higher levels of disability (0= no disability, 100= full disability).

Time Frame Change at 12 week follow-up from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACT-IM Waitlist/Treatment as Usual
Hide Arm/Group Description:

The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.

ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations.

The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
Overall Number of Participants Analyzed 31 14
Mean (Standard Error)
Unit of Measure: units on a scale
-9.1  (2) -.3  (2.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ACT-IM Waitlist/Treatment as Usual
Hide Arm/Group Description

The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.

ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations.

The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
All-Cause Mortality
ACT-IM Waitlist/Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ACT-IM Waitlist/Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ACT-IM Waitlist/Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/14 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Lilian Dindo, PhD
Organization: Baylor College of Medicine
Phone: 713-791-1414 ext 10296
Publications:
Blackledge, J.T. & Hayes, S.C. Using Acceptance and Commitment Training in the support of parents of children diagnosed with Autism. Child and Family Behavior Therapy. 2006;28(1):1-18.
Dahl, J., Wilson, K.G., Nilsson, A. Acceptance and Commitment Therapy and the treatment of persons at risk for long-term disability resulting from stress and pain symptoms: A preliminary randomized trial. Behavior Therapy. 2004;35:785-801.
Responsible Party: Lilian N. Dindo, University of Iowa
ClinicalTrials.gov Identifier: NCT01775852     History of Changes
Other Study ID Numbers: 201004763
ICTS-01 ( Other Grant/Funding Number: University of Iowa, ICTS )
First Submitted: January 9, 2012
First Posted: January 25, 2013
Results First Submitted: June 4, 2015
Results First Posted: September 17, 2015
Last Update Posted: February 22, 2018