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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02734992
• Date of registration: 21/03/2016
• Prospective Registration: No
• Primary sponsor: University of Cyprus
• Public title: Acceptance and Commitment Therapy vs Medical Treatment as Usual Wait-list Control for Primary Headache Sufferers ALGEA
• Scientific title: An Innovative Psychosocial Intervention for the Treatment of Chronic Pain Patients and Their Families
• Date of first enrolment: September 2014
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02734992
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Cyprus

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Headache

Intervention(s)

Behavioral: ACT+ MTAU

Behavioral: Waitlist Control +MTAU

Primary Outcome(s)

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 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]

Secondary Outcome(s)

Greek Brief pain inventory: the pain severity subscale (G-BPI; Mystakidou, Mendoza, [Time Frame: 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) [Time Frame: Group by time Changes from Baseline Headache Disability at 3 months follow-up]

The Hospital Anxiety and Depression Scale (HADS; Zigmond, & Snaith, 1983) [Time Frame: 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). [Time Frame: Group by time Changes from Baseline Headache Disability at 3 months follow-up]

Secondary ID(s)

K3_K1_0

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Crete