Study design and procedures

We conducted a single-arm open-label prospective exploratory pilot feasibility study from April 2023 to May 2024 to evaluate the feasibility and acceptability of CC, a psychological telehealth group intervention, in a tertiary headache center. The study was approved by the Women’s College Hospital (WCH) Research Ethics Board (REB# 2022-0150-E). The study was explained over the phone, and participants had an opportunity to ask questions and think about responses before providing electronic informed consent. Informed consent and all other research forms and questionnaires were sent to participants and completed through the secure electronic platform REDCap. Renumeration ($25 gift certificate) was provided following completion of each set of questionnaires at baseline, post-treatment and 2-month follow-up period.

Participants

Participants were recruited from the Centre for Headache, a tertiary outpatient clinic in Toronto, Ontario, Canada. The Centre for Headache population is complex and treatment refractory, having failed primary and secondary headache care and, often, several trials of specialized tertiary headache pharmacological and interventional treatments. In recruiting from this population, the study had an explicit focus on improving equity for complex patients who are excluded from most studies, making it a pragmatic, real-world approach. We included patients who were 18 years old and older and had a history of primary headache, including migraine, with a frequency of 8 or more days per month (i.e., high-frequency episodic or chronic headache). Headache diagnosis and frequency were determined by a headache neurologist or nurse practitioner using the International Classification of Headache Disorders-3 criteria. Exclusions were few and included those unable to consent, unable to speak or read English or without internet access and those with a secondary headache disorder as their principal headache diagnosis. In addition, for safety purposes, individuals with severe and unstable psychiatric conditions such as schizophrenia, untreated bipolar disorder, active suicidal ideation or active substance use disorder were excluded. Also consistent with pragmatic design,^{Reference Loudon, Treweek and Sullivan18} participants continued their usual care throughout the study; however, they were restricted from taking part in another group psychological intervention.

Intervention

Following consent, two group facilitators invited participants to a 20-minute video telehealth intake session to review the therapy model, build a therapeutic alliance and prepare participants for the group. CC was a 9-week manualized psychological telehealth group intervention for headache that integrated EAET with elements of anxiety regulation, cognitive restructuring, relaxation training, mindfulness and headache education. A group-based intervention was chosen, as it takes less therapist time compared to individual therapy, leading to a more sustainable and scalable treatment option beyond the end of the trial, and because group-based EAET has been shown to be robustly effective for chronic musculoskeletal pain.^{Reference Yarns, Jackson and Alas9} Telehealth and group format also served an equity goal, allowing increased access to the study, as this tertiary care clinic serves a large regional population. All modalities integrated into CC have all previously been conducted in group settings. This program was developed by a multidisciplinary team consisting of a psychiatrist (O.Z.) and social worker (L.J.) at the Centre for Headache, with consultation from local and international experts in the field of headache and pain medicine (C.L., V.L., AM.L.B., B.C.Y., M.Z.) and anonymous feedback from patients following group completion before and during the study. The development of program content and participant material included a literature review of key information regarding migraine behavioral and psychological interventions, summarized in Zamir et al. (Reference Zamir, Yarns and Lagman-Bartolome2023).^{Reference Zamir, Yarns and Lagman-Bartolome7} O.Z. developed detailed facilitator and participant manuals for CC, with support from L.J. and B.C.Y., which included psychoeducation, worksheets and experiential exercises based on CBT, MBIs, trauma-focused anxiety regulation and EAET.^{Reference Lumley and Schubiner19} Sessions were 105 minutes in duration for the first cycle and lengthened to 120 minutes for the following two cycles, based on participant feedback during this exploratory pilot study, and included approximately 10–12 participants per group. Sessions used WCH’s security-protected Zoom virtual video format within the EPIC electronic medical record system. The two group facilitators were experienced mental health clinicians in the field of medical care.

CC targeted three components of headache progression (Figure 1), which included (1) anxiety regulation, (2) identifying emotional avoidance and cognitive restructuring and (3) emotional processing. Table 1 summarizes each session’s content. Briefly, mindfulness and relaxation practices started and ended all sessions to support awareness, regulation and processing experiences. Session one included neuroscience education based on the EAET model and tailored for headache patients (i.e., headache progression can occur with the avoidance of stressful emotional experiences, thereby changing brain circuitry). Session two included a multicomponent approach to anxiety and its optimization to promote better functioning. Two models of anxiety were integrated. Participants were introduced to the ISTDP model of three anxiety “channels”: striated muscle anxiety (e.g., muscle tension in the back or neck), smooth muscle anxiety (e.g., tension in the smooth muscle of the gut or blood vessels leading to so much anxiety that one develops nausea, vomits or has a headache) and mental processes (e.g., being so anxious that one cannot think clearly).^{Reference Abbass20} Identifying the channel can help participants identify and label anxiety manifestations in the body so that they may be regulated into what is viewed as the “healthier” striated muscle channel. The three anxiety channels were mapped onto and integrated with a second trauma-based model, the window of tolerance,^{Reference Siegel21} which focuses on maintaining anxiety at an “optimal,” or moderate, level to promote better functioning. The session also presented several anxiety regulation strategies, such as grounding. Session three introduced the concept of emotional avoidance based on maladaptive, distorted cognitions and the psychodynamic concept of defenses. Starting session four, emotional processing was the primary focus. The goal was to process current life experiences and link them to early adverse events through experiential practices. Each week, education was provided on one of the adaptive emotions outlined in the EAET/ISTDP framework, including anger, guilt, grief and love, which are commonly in conflict and avoided in relationships due to life adversities.^{Reference Lumley and Schubiner19}

Figure 1. Creating Calm targets headache progression. Note: Creating Calm targets three components proposed to be responsible for headache progression by encouraging (1) emotional processing to address avoided emotions associated with life stressors, (2) identification of defenses and cognitive restructuring to target maladaptive cognitions and defenses and (3) identification and regulation skills to target anxiety and somatic symptoms.

Table 1. Creating Calm session content

* Homework introduced for all sessions, with emphasis in sessions 1–3 on building a relaxation and grounding practice and sessions 4–8 on written exercises to encourage emotional experiencing.

A key part of EAET is to process stress and adversity-related emotions based on the notion that chronically avoiding emotions results in symptoms.^{Reference Lumley and Schubiner8,Reference Lumley and Schubiner19} Emotions faced directly in the safe environment of the therapy setting, through experiencing, expressing and releasing (EER) practices, support symptom reduction or elimination. EER, informed by psychodynamic psychotherapy, encourages participants to experience emotions in the body (e.g., anger with sensations of heat and energy), express the feeling in words and imagination and then release it (e.g., say goodbye to the anger, let it go).^{Reference Lumley and Schubiner8} The emphasis is on guiding the participants toward emotions they have been avoiding, allowing them to experience empowerment and a new experiential understanding of events in which these emotions were initially avoided due to threatening or dismissive messages from caregivers or others. Participants who may be detached from emotions related to adversity and have significant anxiety can be easily overwhelmed, which is commonly seen with chronic migraine and headache.^{Reference Minen, Begasse De Dhaem and Kroon Van Diest3,Reference Caponnetto, Deodato and Robotti22} In such cases, a graded approach is used to process emotions, which includes anxiety regulation and integration strategies from ISTDP, CBT and MBI practices, as well as initially guiding participants toward life experiences where emotions can be more readily accessed (e.g., anger after getting cut off in traffic) before examining more traumatic experiences. Further processing is encouraged through written emotional expression exercises assigned for homework. In the later weeks, we also introduced adaptive relational communication strategies.

Assessments

Once consented, participants completed baseline demographic, clinical history and outcome questionnaires. Participants also downloaded headache diaries to be completed manually for the month before initiating the intervention and 2 months following the intervention. Baseline demographics and clinical history included gender, education, race/ethnicity, marital status, employment, income, trauma history detemined using the Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5)^{Reference Gray, Litz and Hsu23} and pain history. Chart review by a trained research assistant gathered data on sex, age, headache age of onset, diagnosis, frequency, medications, as well as psychiatric diagnoses and ACE history. As part of standard practice in the clinic, neurologists and nurse practitioners had systematically inquired about ACEs during the initial clinic consultation and recorded this information in the chart.

Outcomes

Our primary outcome was the feasibility and acceptability of CC. The feasibility outcome was based on recruitment (i.e., number screened and enrolled in program) as well as adherence to protocol (i.e., survey completion) and retention (i.e., attendance). The aim for each group cycle was to recruit enough people for 10–12 participants in each group for a total of 30–36 participants in the study over the duration of 12–14 months. Optimal program completion was defined as 80% or more of participants attending 7 out of 9 sessions (i.e., 75% of the program sessions).^{Reference Fernandez, Salem and Swift24} We also reported the percentage of people who completed questionnaires. We evaluated acceptability as satisfaction with the program, which was measured using the Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)^{Reference Oei and Green25} scale, a validated tool to measure satisfaction with therapy. This was completed by the participants at the end of the intervention. The score includes 12 items for therapy and therapist satisfaction (range 12–60) and 1 item for global impression of change (range 1–5).

To support planning for a future randomized control trial, we also explored headache frequency and associated disability using a headache diary (documenting headache days on a calendar downloaded using a REDCap link) in the month before initiating CC and 2 months after the conclusion of the intervention (to evaluate intermediate effects). Headache-related burden was noted daily on this diary using a colored coded model, the Traffic Light Headache Diary^{Reference Lagman-Bartolome and Lay26} whereby participants described the maximum disability level of the day using three colors: (1) GREEN indicated a mild headache and/or associated symptoms (light, sound intolerance, nausea, cognitive fog, etc.) without significant disability, meaning the participant could “go” about their day; (2) YELLOW indicated a headache and/or associated symptoms, which reached moderate severity or severe enough to interfere with functioning and caused them to “slow down” activities; and (3) RED indicated a severe, disabling headache and/or associated symptoms, requiring them to fully “stop” their activities. A Traffic Light score was obtained by assigning 3 points for a RED day, 2 points for a YELLOW day and 1 point for a GREEN day. Days with no headache or headache-related symptoms received 0 points for a “Crystal Clear Day.” Participants were contacted by the research team up to three times throughout the program to encourage them to complete headache diaries.

Finally, several outcomes of psychosocial well-being and disability were collected at baseline, after the completion of the program and 2 months after the program. Validated self-report questionnaires included the Headache Impact Test-6 (HIT-6)^{Reference Yang, Rendas-Baum, Varon and Kosinki27} to measure headache-related disability, the Patient Health Questionnaire-8 (PHQ-8)^{Reference Kroenke, Strine and Spitzer28} to measure depression, PROMIS Anxiety Short-Form 8a^{Reference Schalet, Pilkonis and Yu29} to measure anxiety, 20-item post-traumatic stress disorder checklist for DSM-5 (PCL-5)^{Reference Bovin, Marx and Weathers30} to measure trauma symptoms and the 8-item PROMIS Global Health^{Reference Lapin, Davin and Stilphen31} to measure function. Five potential mechanisms of change were assessed using validated questionnaires: Emotional Approach Coping Scales-8 (EACS-8)^{Reference Stanton, Kirk and Cameron32} to measure emotional coping; 10-item Cognitive and Affective Mindfulness Scale – Revised (CAMS-R)^{Reference Feldman, Hayes, Kumar, Greeson and Larenceau33} to measure mindfulness; 13-item Pain Catastrophizing Scale (PCS)^{Reference Sullivan, Bishop and Pivik34} to measure catastrophizing; Survey of Pain Attitudes Emotion subscale^{Reference Jensen, Turner and Romano35} to measure pain attitude; and 12-item Self-Compassion Scale – Short Form^{Reference Raes, Pommier and Neff36} to measure self-compassion.

Statistical analyses

Descriptive statistics were calculated for baseline demographics, characteristics of the group and STTS-R satisfaction measures, with means and standard deviations for continuous measures and numbers and percentages for categorical measures. For exploratory purposes only, we compared the mean headache frequency (days per month) and mean headache burden (Traffic Light score) before and 2 months after the intervention using paired t-tests.^{Reference Hoel37} For any given day, the worst of the three levels of headache burden was taken as the score using the points system described earlier. For all psychosocial scales, we compared the scores post-treatment vs. baseline and at 2-month follow-up vs. baseline using paired t-tests. All analyses were carried out in STATA Version 18.1. As this was a pilot study, we set p < 0.05 as the threshold for statistical significance for all tests as opposed to applying a Bonferroni or other correction for multiple comparisons, as one would do in a randomized controlled trial. It is commonplace to use relaxed p-values to aid in the interpretation of results in pilot studies.^{Reference Arain, Campbell and Cooper38}