Overview

This trial is active, not recruiting.

Condition headache
Treatments act+ mtau, waitlist control +mtau
Sponsor University of Cyprus
Collaborator University of Crete
Start date September 2014
End date March 2015
Trial size 180 participants
Trial identifier NCT02734992, K3_K1_0

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 effects of an ACT-based intervention when added to medical treatment as usual (MTAU) vs. a wait list control group comprised only of MTAU, on improving quality of life and decreasing disability among headache sufferers.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Other)
The Acceptance and Commitment therapy + MTAU (active treatment) consists of an unpublished manual developed for the purposes of the Algea project (Vasiliou & Karekla, 2015). Sessions focus in fostering the six ACT processes targeting at increasing psychologically flexible responses to headache episodes and enhancing behavioral changes. The protocol specifies the following goals: (a) increase individuals' willingness to face uncomfortable internal experiences; b) promoting meaningful activities even in the present of head pain; (c) emphasizing acceptance as an alternative to avoidance in coping with headache; (d) clarifying individuals' values in important life domains; e) enhancing present moment-to-moment awareness.
act+ mtau The ALGEA STUDY
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 hours. The control group will receive the ACT intervention following the completion of the Tx group. Participants will fill out questionnaires before and after the intervention and at a 3, 6 and 12-month 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 to promote psychological flexibility.
(Other)
The MTAU/ Wait-list Control Gr will follow their usual treatments, including any new treatments their GPs or Neurologists might prescribe (mostly prophylactic and abortive medication), during the study at the time. Following the completion of the active group follow up 3months, participants allocated to the control group will receive the active treatment.
waitlist control +mtau
Participants in the Waitlist control+ MTAU will not receive any active intervention. Upon completion of ACT+MTAU group, participants allocated in the Waitlist control+MTAU will receive the ACT intervention.

Primary Outcomes

Measure
The Henry Ford Hospital Headache Disability Inventory (b-HDI; Jacobson, Ramadan, Aggarwal & Newman, 1994)
time frame: Change from Baseline Headache Disability at an average of 1 year

Secondary Outcomes

Measure
The Chronic Pain Acceptance Questionnaire (CPAQ; McCracken, 1999)
time frame: Change from Baseline Pain Acceptance at an average of 1 year
Psychological inflexibility in pain scale (PIPS-II; Wicksell, Lekander, Sorjonen & Olsson, 2010)
time frame: Change from Baseline Psychological Flexibility Levels at an average of 1 year
Committed Action Questionnaire (CAQ; McCracken, Chilcot, & Norton, 2014),
time frame: Change from Baseline Committed Actions Levels at an average of 1 year
The Hospital Anxiety and Depression Scale (HADS; Zigmond, & Snaith, 1983)
time frame: Change from Baseline Anxiety and Depression Levels at an average of 1 year
Greek Brief pain inventory: the pain severity subscale (G-BPI; Mystakidou, Mendoza,
time frame: Change from Baseline Pain Intensity levels at an average of 1 year
The Migraine- Specific Quality of Life Questionnaire (MSQ v 2.1; Martin et al., 2000; under permission given by GlaxoSmithKline; GSK USMA health outcome group),
time frame: Change from Baseline Quality of Life Levels at an average of 1 year

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: 1. at least four headache episodes per month that meet the diagnostic criteria according to the Headache Classification Committee of The International Headache Society (International Classification of Headache Disorders-II [ICHD-II]; HIS, 2004), 2. age 18 years or older, 3. reading ability sufficient to comprehend self-monitoring forms as well as competence in the Greek language , 4. the use of prophylactic, abortive, psychotropic, analgesics or other headache medications must have begun at least four weeks before treatment, should be stable, continued throughout the trial, tracked and reported. Exclusion Criteria: 1. an active non pharmacologically-controlled psychotic spectrum condition or manic episodes, suicidal ideation/ intent or substance use problems within the 6 months prior to recruitment; 2. history of seizure, facial neuralgia or secondary headache diagnosis, as these conditions might preclude the accuracy of primary headache diagnosis; 3. no significant cognitive impairment, as answered using the Mini-mental Status Examination (MMSE) -

Additional Information

Official title An Innovative Psychosocial Intervention for the Treatment of Chronic Pain Patients and Their Families
Description Research to date suggests that individuals with headache may use experiential avoidance as a coping mechanism to manage pain or other private events (e.g. thoughts) related to their headache difficulties. Despite the wide use of avoidance in headache management, very little empirical evidence exists to support its effectiveness. Indeed, attempts at avoiding headache triggers or other internal private experiences associated with 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, emphasize acceptance and valued-living as alternatives to avoidance, have demonstrated to reduce headache-related disability and improve quality of life. Though APA has recently included ACT as an empirically supported treatment for chronic pain, very little evidence exists as to its effectiveness for head pain. The purpose of the present study is twofold. First, it examines, in a Randomized control study (RCT), how an ACT-based intervention for headache sufferers (added to medical treatment as usual-MTAU) improves quality of life and decreases disability. Second, it investigates whether the proposed process of change mechanism (i.e., acceptance and values-based actions) mediates headache interference and treatment outcomes (i.e. quality of life). It is expected that the ACT-based group in comparison to only MTAU group, will result in lower headache-related interference, higher emotional and physical functioning and increase in quality of life. Results of this study will offer new evidence regarding the utility of ACT in the management of primary headaches.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Cyprus.