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Acceptance and Commitment Therapy vs Medical Treatment as Usual Wait-list Control for Primary Headache Sufferers

NCT02734992 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-07-16

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

ACT+ MTAU

Participants will be randomly assigned to one of the two groups: ACT-based intervention, plus their usual health care or Medical Treatment as Usual only (MTAU). The MTAU group will follow their usual medical treatment (prescribed headache medication). Treatment sessions will be conducted weekly by two co-therapists in groups of approximately 8-10 participants for 1 ½ hour. The control group will receive the ACT intervention following the completion of the 3-months follow-up assessment of the treatment group. Participants in both groups will complete primary and secondary outcome scales, as well as ACT process effects scales at pre, post and 3-months follow-up. The treatment group only will be also assessed at 6 and 12-months follow-up. The ACT protocol and the patients' workbook were developed for the needs of the Algea project (Vasiliou \& Karekla, 2015). Techniques will focus on key ACT processes aiming at promoting psychological flexibility for the head pain experience.

BEHAVIORAL

Waitlist Control +MTAU

Participants in the Waitlist control+ MTAU will not receive any active intervention. Upon completion of the 3 months follow-up assessment of the ACT+MTAU group, participants allocated in the Waitlist control+MTAU will receive the ACT intervention.

Sponsors & Collaborators

  • University of Crete

    collaborator OTHER

  • University of Cyprus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-03-31
Completion
2016-12-31

Countries

  • Cyprus

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02734992 on ClinicalTrials.gov