An interventional study of Acceptance and Commitment Therapy-Based Group Psychotherapy and Psychoeducation in Chronic Headache, sponsored by Saglik Bilimleri Universitesi. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Treatment
The goal of this randomized clinical trial is to find out whether Acceptance and Commitment Therapy (ACT)-based group psychotherapy can improve depression, anxiety and quality of life in adults with chronic headache compared with psychoeducation.
The main questions the study aims to answer are:
Participants were randomly assigned to one of two groups: ACT-based group psychotherapy or psychoeducation.
Both interventions consist of four weekly group sessions, each lasting about 90 minutes. Study assessments are conducted before the first group session, after the fourth session and 1 month after the final session.
This is a prospective randomized controlled study evaluating Acceptance and Commitment Therapy (ACT)-based group psychotherapy in adults diagnosed with chronic headache. A total of 72 participants were enrolled and assigned using simple randomization to two groups: an ACT-based group psychotherapy group and a psychoeducation group.
All participants were receiving pharmacotherapy for chronic headache at enrollment. Both study interventions consist of four group sessions at weekly intervals with each session lasts approximately 90 minutes.
The ACT-based group psychotherapy protocol includes values, values-based action planning, acceptance, cognitive defusion, flexible contact with the present moment and self-as-context processes. The comparison group receives psychoeducation.
Study assessments are conducted at baseline before the first group session, at the end of the fourth session (up to 1 month) and 1 month after the final session. The assessments examine depression, anxiety, headache-related impact, quality of life, psychological flexibility, repetitive negative thinking, values-based living and pain intensity. Psychotherapy satisfaction is assessed 1 month after the final session. Group sessions are supervised by specialist physicians involved in the study.
145 studies on the registry are indexed under Headache Disorders; 37 are open to participants now.
This study's enrollment of 72 is above the median of 60 across 98 interventional studies indexed under Headache Disorders.
Browse Headache Disorders studies →Saglik Bilimleri Universitesi is the lead sponsor of 453 studies on the registry; 140 are open to participants now.
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Exclusion Criteria:
Participants receive Acceptance and Commitment Therapy (ACT)-based group psychotherapy in addition to their ongoing pharmacotherapy for chronic headache. The intervention consists of four weekly group sessions, each lasting approximately 90 minutes.
Behavioral: Acceptance and Commitment Therapy-Based Group Psychotherapy
Psychoeducation is delivered in four weekly group sessions, each lasting approximately 90 minutes.
Behavioral: Psychoeducation
The ACT-based group psychotherapy protocol consists of four weekly group sessions, each lasting approximately 90 minutes. The intervention includes values, values-based action planning, acceptance, cognitive defusion, flexible contact with the present moment, and self-as-context processes.
Psychoeducation is delivered in four weekly group sessions, each lasting approximately 90 minutes.
Change in Depression and Anxiety Levels Assessed by the Depression Anxiety Stress Scales-21 (DASS-21)
The Depression Anxiety Stress Scales-21 (DASS-21) is a 21-item self-report measure and a shortened version of the original 42-item Depression Anxiety Stress Scales (DASS-42). It consists of three 7-item subscales assessing depression, anxiety, and stress. Each item is rated from 0 to 3. For each subscale, the seven item scores are summed to obtain a raw score ranging from 0 to 21, and the raw score is then multiplied by 2 to obtain the final subscale score ranging from 0 to 42. In this study, the Depression and Anxiety subscale scores are evaluated. Higher scores indicate greater symptom severity and therefore a worse outcome.
Time frame: Baseline (before the first group session), at the end of the fourth session (up to 1 month) and 1 month after the final session
Change in Headache Impact Assessed by the Headache Impact Test-6 (HIT-6)
The Headache Impact Test-6 (HIT-6) is a 6-item self-report measure assessing the impact of headache on daily life, including pain, social functioning, role limitations, cognitive functioning, psychological distress, and vitality. Total scores range from 36 to 78, with higher scores indicating a greater negative impact of headache on daily life and therefore a worse outcome.
Time frame: Baseline (before the first group session), at the end of the fourth session (up to 1 month) and 1 month after the final session
Change in Health-Related Quality of Life Assessed by the Short Form-12 Health Survey (SF-12)
The Short Form-12 Health Survey (SF-12) is a 12-item measure assessing health-related quality of life. It provides Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Standardized scores range from 0 to 100, with higher scores indicating better health-related quality of life and therefore a better outcome.
Time frame: Baseline (before the first group session), at the end of the fourth session (up to 1 month) and 1 month after the final session
Change in Psychological Flexibility and Experiential Avoidance Assessed by the Acceptance and Action Questionnaire-II (AAQ-II)
The Acceptance and Action Questionnaire-II (AAQ-II) is a 7-item self-report measure assessing experiential avoidance and psychological flexibility. Each item is rated from 1 to 7, resulting in a total score ranging from 7 to 49. Higher scores indicate greater experiential avoidance and lower psychological flexibility and therefore a worse outcome.
Time frame: Baseline (before the first group session), at the end of the fourth session (up to 1 month) and 1 month after the final session
Change in Engaged Living Assessed by the Engaged Living Scale (ELS)
The Engaged Living Scale (ELS) is a 16-item self-report measure assessing engagement with personal values and life fulfillment. It consists of Valued Living and Life Fulfillment subscales. Each item is rated from 1 to 5, resulting in a total score ranging from 16 to 80. Higher scores indicate greater engaged living, including greater engagement with personal values and life fulfillment, and therefore a better outcome.
Time frame: Baseline (before the first group session), at the end of the fourth session (up to 1 month) and 1 month after the final session
Change in Pain Intensity Assessed by the Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) assesses subjective pain intensity on a scale ranging from 0 to 10, where 0 represents no pain and 10 represents unbearable or the worst possible pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
Time frame: Baseline (before the first group session), at the end of the fourth session (up to 1 month) and 1 month after the final session
Psychotherapy Satisfaction
Psychotherapy satisfaction is assessed using a measure consisting of five closed-ended questions rated from 1 (not at all) to 4 (completely), together with one open-ended question about participants' views of the psychotherapy process. Higher ratings on the closed-ended questions indicate greater psychotherapy satisfaction. The open-ended question is not scored.
Time frame: 1 month after the final session
Change in Repetitive Negative Thinking Assessed by the Perseverative Thinking Questionnaire (PTQ)
The Perseverative Thinking Questionnaire (PTQ) is a 15-item self-report measure assessing repetitive negative thinking independent of thought content. Each item is rated from 0 to 4, resulting in a total score ranging from 0 to 60. Higher scores indicate greater repetitive negative thinking and therefore a worse outcome.
Time frame: Baseline (before the first group session), at the end of the fourth session (up to 1 month) and 1 month after the final session
Plan to share: No — Individual participant data will not be shared.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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