We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01775852
First Posted: January 25, 2013
Last Update Posted: May 25, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Lilian N. Dindo, University of Iowa
Results First Submitted: June 4, 2015  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
ACT-IM

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.

Waitlist/Treatment as Usual 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.

Participant Flow:   Overall Study
    ACT-IM   Waitlist/Treatment as Usual
STARTED   31   14 
COMPLETED   31   13 
NOT COMPLETED   0   1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ACT-IM

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.

Waitlist/Treatment as Usual 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 Total of all reporting groups

Baseline Measures
   ACT-IM   Waitlist/Treatment as Usual   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   14   45 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.5  (13.3)   33.5  (12.9)   33  (13.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      30  96.8%      12  85.7%      42  93.3% 
Male      1   3.2%      2  14.3%      3   6.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 12 Week Follow-up   [ Time Frame: 12 week change from baseline ]

2.  Secondary:   Mean Change Score in HDI (Headache Disability Inventory) From Baseline to 12 Weeks.   [ Time Frame: 12 week change from baseline ]

3.  Secondary:   Mean Change on Short Form Health Survey (SF-36) From Baseline to 12 Week Follow-up.   [ Time Frame: Change at 12 week follow-up from baseline ]

4.  Secondary:   Mean Change of World Health Organization Disability Assessment (WHO-DAS) From Baseline to 12-week Follow up.   [ Time Frame: Change at 12 week follow-up from baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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
e-mail: lilian.dindo@bcm.edu


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: May 25, 2017