Ignite Creation Date:
2024-05-06 @ 8:26 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02734992
Status:
COMPLETED
Last Update Posted:
2019-07-16
First Post:
2016-03-21
Brief Title:
Acceptance and Commitment Therapy vs Medical Treatment as Usual Wait-list Control for Primary Headache Sufferers
Sponsor:
University of Cyprus
Organization:
University of Cyprus
Study Overview
Official Title:
An Innovative Psychosocial Intervention for the Treatment of Chronic Pain Patients and Their Families
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALGEA
Brief Summary:
Research to date suggests that individuals with headache use avoidance as a way to manage their pain Despite the wide use of avoidance as a coping mechanism of headache triggers very little empirical evidence exist to support its effectiveness in headache management New treatment approaches such as Acceptance and Commitment Therapy ACT emphasize acceptance of headache and valued-living as alternatives to avoidance have demonstrated preliminary support in helping individuals reduce headache-related disability and improve quality of life Though ACT has received empirical support for various chronic pain conditions very little evidence exists as to its effectiveness for head pain problems The current study will examine the efficacy of an ACT-based intervention when added to medical treatment as usual MTAU vs a waitlist control group across time group differences at 3 months and time changes for the ACT group at 12-months follow-up on quality of life and general disability among headache sufferers
Detailed Description:
The main behavioral treatment suggestion today for headache management is the prevention of headaches mostly via avoidance of external and internal headache triggers Despite the wide use of avoidance in headache management very little empirical evidence exists to support its effectiveness Attempts at avoiding headache triggers or other internal private experiences associated with a headache may increase trigger potency restrict lifestyle decrease internal locus of control and exacerbate and maintain pain perception New treatment approaches such as Acceptance and Commitment Therapy ACT emphasize acceptance and valued living as alternatives to avoidance Though ACT is an empirically supported treatment for chronic pain there is limited evidence for its efficacy for head pain and this evidence is afflicted with methodological limitations that need to be overcome before making conclusions as to the effectiveness of ACT for headaches The purpose of the present study is to examine in a Randomized Controlled Trial RCT whether an ACT-based intervention for headache sufferers added to Medical Treatment as Usual decreases disability and improves the quality of life compared to only Wait List Control WL Pre post and 3-months group changes will be assessed Patients participating in the ACT group will be monitored for a year period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None