An Innovative Psychosocial Intervention for the Treatment of Chronic Pain Patients and Their Families
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Cyprus
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- The Henry Ford Hospital Headache Disability Inventory (b-HDI; Jacobson, Ramadan, Aggarwal & Newman, 1994)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Acceptance and Commitment therapy + MTAU
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.
Intervention: ACT+ MTAU (Behavioral)
MTAU/ Wait-list Control Gr
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.
Intervention: Waitlist Control +MTAU (Behavioral)
Outcomes
Primary Outcomes
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
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.
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: Group by time Changes from Baseline Headache Disability at 3 months follow-up
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.
Secondary Outcomes
- Greek Brief pain inventory: the pain severity subscale (G-BPI; Mystakidou, Mendoza,(Group by time Changes from Baseline Headache Disability at 3 months follow-up)
- 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).(Group by time Changes from Baseline Headache Disability at 3 months follow-up)
- The Hospital Anxiety and Depression Scale (HADS; Zigmond, & Snaith, 1983)(Group by time Changes from Baseline Headache Disability at 3 months follow-up)
- Number of visits to different physicians due to Headache (Adapted with permission from Vowles et al., 2008)(Group by time Changes from Baseline Headache Disability at 3 months follow-up)
Investigators
Maria Karekla
Licensed Clinical Psychologist, Assistant Professor, Peer reviewed ACT trainer,
University of Cyprus