The current semi-experimental study was conducted at Shahid Beheshti governmental hospital of Kashan, Iran in 2016. The research committee of Kashan University of Medical Sciences approved the study (ethical code, IR.KAUMS.MEDNT.REC.1396.53). The participants signed an informed consent form and were given information about the purpose of the study and their right to withdraw from the study. They were assured about the confidentiality of their personal information.
The participants included adults with chronic daily headache/migraine, who were referred by expert neurologists to the neurology clinic of Shahid Beheshti hospital of Kashan, Iran. The inclusion criteria were as follows: 1, chronic daily headache according to the international classification of headache disorders (third edition, beta version) (35); 2, willingness to participate in the study; 3, age range of 18 – 60 years; 4, no medical diagnosis of organic brain or psychotic disorders; 5, no history of psychological treatments in the preceding six months; 6, lack of other chronic pain problems; and 7, no history of epileptic seizures or facial nerve pain.
The sample size was determined, based on the information extracted from a study by Gharaei-Ardakani et al. on the effectiveness of ACT in reducing the severity of pain experience in women with chronic headache disorder (36). The sample size was estimated at 20 subjects per group considering the effect of pain severity with a mean (standard deviation) of 3.53 (2.1) for the intervention group and 7.73 (1.7) for the control group at a significance level of 0.05 and power of 95% (second type error, 20%, β, 0.2; d, 2), using the following formula:
Forty patients were selected via purposive sampling and randomly assigned to ACT and medical treatment as usual (MTAU) groups through block randomization.
The MTAU group was treated with antidepressants, beta-blockers, calcium-channel blockers, or anticonvulsants. The ACT group received ACT training in addition to MTAU. The ACT group was trained for eight weeks by an expert with a Master’s degree in clinical psychology under the supervision of a clinical psychologist with a PhD degree. The adopted Persian ACT protocol for chronic pain, based on the manual of Vowles and colleagues (37), was used in this intervention. The ACT comprised of eight 90-minute weekly group sessions in two months. The overall content of the sessions is presented in Table 1.
|Sessions||Objectives and Content|
|1||A, Review of treatment history; B, introduction of the possibility that change is possible, but perhaps not through symptom reduction.|
|2||A, Review of interactions between feelings, thoughts, and actions that lead to vicious cycles; (B) exercises to control thoughts and/or emotions; C, introduction of the idea that changes in action may mean changes that directly contribute to meaningful and successful living (i.e., values), not changes in stubborn avoidance behaviors; D, mindfulness practice.|
|3||A, Value-clarification exercises and emphasis on awareness and identification; B, practice of mindful breathing.|
|4||A, Continued value-clarification exercises; B, discussion about barriers and exercise of value-based actions, even in aversive situations; C, setting an effective goal related to values; D, body sensation awareness exercises.|
|5||A, Discussion about activity cycling and pacing; B, cognitive defusion exercises; C, awareness exercises.|
|6||A, Continued cognitive defusion exercises; B, “thought watching” exercise; C, continued discussion of openness to experience discomfort in the service of a meaningful life.|
|7||A, Awareness and exercises pertaining to the ways in which people add additional, often unnecessary, distress to already distressing situations; B, continued discussion about willingness towards a meaningful life; C, mindful walking exercise.|
|8||A, Preparation for relapses and setbacks.|
CERQ is a 36-item questionnaire, consisting of nonadjustment and adjustment emotion regulation strategies. All items are rated on a five-point Likert scale, ranging from one (almost never) to five (almost always) (39); a higher subscale score reflects the greater use of the strategy. Research on cognitive emotion regulation strategies has shown that all subscales have good internal consistencies (40). Cronbach’s alpha for internal consistency of the subscales ranges from 0.60 to 0.80 (41). A previous study regarding the reliability of adjustment and nonadjustment strategies reported Cronbach’s alpha coefficients of 0.91 and 0.87, respectively (39). In another study from Iran, the reliability of CERQ was measured using Cronbach’s alpha coefficient (0.82). Also, regarding the validity of the questionnaire, the correlation coefficients of nonadjustment emotion regulation strategies for depression and anxiety were 0.35 and 0.37, respectively in the general health questionnaire (42).
HDI (43) is a 25-item scale for the perceived impact of headache on emotional and daily functioning, with three possible options (“No”, 0 score; “Sometimes”, 2 scores; “Yes”, 4 scores). HDI appears to have acceptable short-term (r, 0.93 – 0.95 for one week) and long-term (r, 0.76 – 0.83 for two months) stability (43, 44). In a study from Iran regarding the reliability of HDI, Cronbach’s alpha coefficients for emotional and functional aspects were 0.68 and 0.83, respectively. In terms of concurrent validity, the correlation coefficients of emotional and functional factors of HDI and symptom checklist (SCL-25) were 0.71, 0.51, and 0.55, respectively (45).
This scale (38) was used as a measure of headache intensity. The patients were asked to record a diary of headache intensity on a rating scale from zero (absence of pain) to ten (most intense disabling headache). The mean headache intensity in one week was calculated by dividing the sum of severity scores by seven. The minimum score of headache severity is zero, while the maximum score is ten. The headache diary was presented to five patients, as well as a neurologist and a psychiatrist, to confirm its content validity (46). The reliability coefficient of the Persian version of the scale is estimated at 0.88 (46).
The collected data were analyzed in SPSS version 24 (SPSS Inc., Chicago, IL, USA). Chi square test was used to compare the demographics in the groups (Table 2). Independent sample t test was used to identify the baseline differences between the intervention and control groups in terms of clinical characteristics. Also, Kolmogorov- Smirnov test was used to describe the normal distribution of variables, followed by parametric tests. Table 3 presents the mean and standard deviation (SD) of dependent variables. Analysis of variance (ANOVA) and repeated measures ANOVA were also performed to compare the groups regarding cognitive emotion regulation strategies, headache-related disability, and headache intensity at pretreatment, posttreatment, and three-month follow-up. P value less than 0.05 was considered significant in all tests.
|Family history of headache|
|With family history||12||14||0.606|
|Without family history||4||3|
Abbreviations: ACT, Acceptance and Commitment Therapy; MTAU, Medical Treatment as Usual.
This content was originally published here.