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

NCT ID: NCT02734992

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-12-31

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.

Conditions

Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

ACT+ MTAU

Intervention Type: BEHAVIORAL

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.

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.

Group Type: OTHER

Waitlist Control +MTAU

Intervention Type: BEHAVIORAL

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.

Interventions

ACT+ MTAU

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.

Intervention Type: BEHAVIORAL

Waitlist Control +MTAU

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

The ALGEA STUDY

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Crete

OTHER

Sponsor Role: collaborator

University of Cyprus

OTHER

Sponsor Role: lead

Responsible Party

Maria Karekla

Licensed Clinical Psychologist, Assistant Professor, Peer reviewed ACT trainer,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Cyprus

Nicosia, , Cyprus

Countries

Cyprus

References

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.

Reference Type: DERIVED

PMID: 34375444 (View on PubMed)

Other Identifiers

K3_K1_0

Identifier Type: -

Identifier Source: org_study_id