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HeadacheALGEANCT02734992

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

A study testing ACT+ MTAU in people with Headache, run by University of Cyprus at 1 site in Cyprus.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Headache
What is being tested?
ACT+ MTAU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteCyprus
Study dates
Sep 2014to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • meeting diagnostic criteria for Primary Headache based on the International Classification of Headache Disorders-II (beta version; 2013);
  • older than 18 years; c) sufficient Greek reading ability; and d) stable pharmacotherapy and headache experience (both remained unchanged for the past four weeks prior to assessment).

Who cannot join

  • had an active psychotic spectrum condition or manic episode, suicidal ideation/intent or substance use problems (particularly misuse of prescription head pain relievers) within the past 6 months;
  • had a history of seizure, facial neuralgia or other secondary headache diagnoses (i.e., conditions that might preclude the accuracy of primary headache diagnosis);
  • scored <20 on the Mini-mental Status Examination suggesting significant cognitive impairment;
  • were living in nursing homes;
  • had multiple pain sides (pain experienced in multiple body sides or groups of muscles);
  • took part in other psychological interventions or counseling (particularly for managing headache) over the last two years;
  • were pregnant or lactating.

Trial locations and contacts

1 site in 1 country.

Cyprus1 site

  • University of Cyprus

    Nicosia, 20537

Other trials in Cyprus

About this study

Official title: An Innovative Psychosocial Intervention for the Treatment of Chronic Pain Patients and Their Families

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.

Read the 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.

Conditions
Headache
Being tested
ACT+ MTAU, Waitlist Control +MTAU
Keywords
Migraines, Tension-type Headache, Acceptance
Medical subject headings
Headache, Migraine Disorders, Tension-Type Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACT+ MTAUBehavioural

    Also called 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 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.

  • Waitlist Control +MTAUBehavioural

    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.

Study groups in NCT02734992
Study groupRoleWhat they receive
Acceptance and Commitment therapy + MTAUOtherThe Acceptance and Commitment therapy + MTAU (active treatment) consists of an unpublished manual developed for the purposes of the Algea project (Vasiliou \& Karekla, 2015). 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. Participants will be asked to remain stable on their pharmacotherapy during this study. All eligible participants will be monitored (medication taken and amount) prior to the beginning of the intervention for three weeks to ensure stability of their conditions. Participants will complete questionnaires at pre-, post-treatment, and at 3-month follow-up. The WL group will enter treatment at the 3-month follow-up of the ACT-group.
Receives: Behavioral: ACT+ MTAU
MTAU/ Wait-list Control GrOtherThe 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. Participants will complete the same questionnaires at three different time points: pre-, post-treatment, and at 3-month follow-up. Participants will be asked to remain stable on their pharmacotherapy during this study and inform the researchers of any changes. All eligible participants will be monitored (medication taken and amount) prior to the beginning of the intervention for three weeks to ensure stability of their conditions. Excluded participants will be referred to appropriate services.
Receives: Behavioral: Waitlist Control +MTAU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Henry Ford Hospital Headache Disability Inventory (b-HDI; Jacobson, Ramadan, Aggarwal & Newman, 1994)

    b-HDI is a 25-item headache disability inventory assesses the effect of headaches on daily activities (e.g. 'Because of my headaches I am less likely to socialize') and emotional functioning (e.g. 'I feel desperate because of my headaches'). Items are divided into two sub-grouped scales: functional, representing the sensory component of headaches (e.g. intensity etc) (13-items); and emotional (12-items), representing the reactive or affective realm (Andrasik, Lipchik, McCrory, \& Wittrock, 2005). The instrument is answered with "yes", "no" or "sometimes" and the higher the score the greater the disability caused by the headache. The b-HDI has shown high reliability (a=.84) and validity with other similar scales. For the purpose of this study, only the general headache disability score will be used, comprising of the two subscales.

    Measured: Group by time Changes from Baseline Headache Disability at 3 months follow-up

  2. 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),

    The MSQ is a 14-items migraine-specific Likert-type scale assesses the impact of migraines on patients' quality of life over the past four weeks. The scale is divided into three dimensions: Role Restrictive (RR; 7 items), Role Preventive (RP; 4 items), and Emotional Function (EF; 3 items). Role- function restrictive describes the degree to which performance of daily activities are limited by migraines. Role Preventive (RP) assesses the amount of normal activities interrupted by migraines. The Emotional Function (EF) evaluates the degree of emotional effects of migraine (e.g., frustration, afraid and burden). Items ranged from 1 (none of the time) to 6 (all of the time). The revised MSQ (version 2.1) appears with sufficient psychometric validity and reliability (a coefficient= .86- .96), across different migraine groups (Cole, Lin \& Rupnow, 2007; Rendas- Baum, Bloudek, Maglinte \& Varon, 2013). For the purpose of this study the three dimensions will be used to assess functional changes.

    Measured: Group by time Changes from Baseline Headache Disability at 3 months follow-up

Secondary outcomes (4)

  1. The Hospital Anxiety and Depression Scale (HADS; Zigmond, & Snaith, 1983)

    HADS is a 14 item questionnaire assessing levels of anxiety and depression symptomatology. Each subscale consists of 7 items rated on a 4-point scale (0-3). Higher scores indicate greater anxiety and depression. The Greek version presents with high internal consistency (Cronbach's alpha=.88) and validity (Michopoulos et al., 2008).

    Measured: Group by time Changes from Baseline Headache Disability at 3 months follow-up

  2. Greek Brief pain inventory: the pain severity subscale (G-BPI; Mystakidou, Mendoza,

    G-BPI is a 4-item scale rated in a Likert-type scale from 0= no pain to 10 = the most severe pain ever experienced. Ratings are taken for the present time and 24 hours prior to the interview. The G-BFI shows good internal consistency (a coefficient= .80) and sufficient validity. The Greek validity has also demonstrated a high reliability (a= .88 for severity) and sufficient validity with other similar instruments.

    Measured: Group by time Changes from Baseline Headache Disability at 3 months follow-up

  3. Number of visits to different physicians due to Headache (Adapted with permission from Vowles et al., 2008)

    articipants, will record the total number of HA-related medical visits had over the last two months at the time of the assessment (# HA- related visits to different physicians). Based on participant estimations, a summary score for number of different HA-related medical visits for HA will be calculated.

    Measured: Group by time Changes from Baseline Headache Disability at 3 months follow-up

  4. Number of medical utilization (# visits to primary care for HA, #visits to Emergency, #department for HA, # hospitalization due to HAs (adapted with permission from Vowles et al., 2008).

    Participants will record the total number of medical utilization had over the last two months at the time of the assessment, (# visits to primary care for HA, #visits to Emergency department for HA, # hospitalization due to HAs). Based on participant estimations, a summary score for number of medical utilization visits will be summed to provide an overall index of medical utilization related to HAs.

    Measured: Group by time Changes from Baseline Headache Disability at 3 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2016 (estimated)
  2. Study startSep 2014
  3. Primary completionMar 2015
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02734992
Sponsor's protocol ID
K3_K1_0
Acronym
ALGEA
Status last verified
Jul 2019
First submitted
21 Mar 2016
Last updated
16 Jul 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Vasiliou VS, Karademas EC, Christou Y, Papacostas S, Karekla M. Mechanisms of change in acceptance and commitment therapy for primary headaches. Eur J Pain. 2022 Jan;26(1):167-180. doi: 10.1002/ejp.1851. Epub 2021 Aug 18.

    PubMed 34375444

Questions about this trial

What is this clinical trial studying?

A study testing ACT+ MTAU in people with Headache, run by University of Cyprus at 1 site in Cyprus.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Henry Ford Hospital Headache Disability Inventory (b-HDI; Jacobson, Ramadan, Aggarwal & Newman, 1994) (time frame: Group by time Changes from Baseline Headache Disability at 3 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02734992, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.

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