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

U

University of Cyprus

Status

Completed

Conditions

Headache

Treatments

Behavioral: Waitlist Control +MTAU
Behavioral: ACT+ MTAU

Study type

Interventional

Funder types

Other

Identifiers

NCT02734992
K3_K1_0

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. meeting diagnostic criteria for Primary Headache based on the International Classification of Headache Disorders-II (beta version; 2013);
  2. 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).

Exclusion criteria

  1. 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;
  2. had a history of seizure, facial neuralgia or other secondary headache diagnoses (i.e., conditions that might preclude the accuracy of primary headache diagnosis);
  3. scored <20 on the Mini-mental Status Examination suggesting significant cognitive impairment;
  4. were living in nursing homes;
  5. had multiple pain sides (pain experienced in multiple body sides or groups of muscles);
  6. took part in other psychological interventions or counseling (particularly for managing headache) over the last two years;
  7. were pregnant or lactating.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

100 participants in 2 patient groups

Acceptance and Commitment therapy + MTAU
Other group
Description:
The 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.
Treatment:
Behavioral: ACT+ MTAU
MTAU/ Wait-list Control Gr
Other group
Description:
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. 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.
Treatment:
Behavioral: Waitlist Control +MTAU

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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