Clinical trial NCT02734992: Acceptance and Commitment Therapy vs Medical Treatment as Usual Wait-list Control for Primary Headache Sufferers
Official title: An Innovative Psychosocial Intervention for the Treatment of Chronic Pain Patients and Their Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Keywords: Migraines
Tension-type Headache
Acceptance
Lead sponsor: University of Cyprus
Sponsor class: OTHER
Collaborators: name: University of Crete
First posted: 2016-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Henry Ford Hospital Headache Disability Inventory (b-HDI; Jacobson, Ramadan, Aggarwal & Newman, 1994)
timeFrame: Group by time Changes from Baseline Headache Disability at 3 months follow-up
measure: 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),
timeFrame: Group by time Changes from Baseline Headache Disability at 3 months follow-up
Secondary outcomes:
measure: The Hospital Anxiety and Depression Scale (HADS; Zigmond, & Snaith, 1983)
timeFrame: Group by time Changes from Baseline Headache Disability at 3 months follow-up
measure: Greek Brief pain inventory: the pain severity subscale (G-BPI; Mystakidou, Mendoza,
timeFrame: Group by time Changes from Baseline Headache Disability at 3 months follow-up
measure: Number of visits to different physicians due to Headache (Adapted with permission from Vowles et al., 2008)
timeFrame: Group by time Changes from Baseline Headache Disability at 3 months follow-up
measure: 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).
timeFrame: Group by time Changes from Baseline Headache Disability at 3 months follow-up
Other outcomes:
measure: The Chronic Pain Acceptance Questionnaire (G-CPAQ Greek adaptation; Vasiliou et al., 2017; Original McCracken et al, 2004)
timeFrame: Group by time Changes from Baseline Headache Disability at 3 months follow-up
measure: Psychological inflexibility in pain scale (G-PIPS; Greek adaptation; Vasiliou et al., 2019; PIPS-II; Wicksell, Lekander, Sorjonen & Olsson, 2010)
timeFrame: Group by time Changes from Baseline Headache Disability at 3 months follow-up
measure: Committed Action Questionnaire (CAQ; McCracken, Chilcot, & Norton, 2014),
timeFrame: Group by time Changes from Baseline Headache Disability at 3 months follow-up
measure: The Valuing Questionnaire (VQ; Smoot et al.,2014)
timeFrame: Group by time Changes from Baseline Headache Disability at 3 months follow-up
measure: The Cognitive Affective Mindfulness Scale-Revised (CAMS-R; Feldman et al., 2006)
timeFrame: Group by time Changes from Baseline Headache Disability at 3 months follow-up
Locations:
city: Nicosia
country: Cyprus
facility: University of Cyprus
Study officials:
References:
citation: 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.