Acceptance and Commitment Therapy vs Medical Treatment as Usual Wait-list Control for Primary Headache Sufferers
Condition: Headache
MeSH terms: Headache
Study type: Interventional

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.
    

Intervention name(s): ACT+ MTAU; Waitlist Control +MTAU
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Other intervention name(s): The ALGEA STUDY
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraines; Tension-type Headache; Acceptance