Chronic HeadacheNCT07906119
Acceptance and Commitment Therapy-Based Group Psychotherapy for Chronic Headache
A study testing Acceptance and Commitment Therapy-Based Group Psychotherapy and Psychoeducation in people with Chronic Headache, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Headache
- What is being tested?
- Acceptance and Commitment Therapy-Based Group Psychotherapy and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Mar 2026to 19 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years.
- Diagnosis of chronic headache according to ICHD-3 criteria.
- Currently receiving pharmacotherapy for chronic headache.
- Literate.
- Willingness to participate in the four-session weekly psychotherapy program and the study.
Who cannot join
- Presence of visual and/or hearing impairment.
- Currently receiving psychotherapy.
- Presence of any psychotic disorder, an active mood episode, intellectual disability, dementia, or another condition interfering with the interview.
- Initiation of a new psychiatric or neurological treatment during the study, or a change in medication or dose of prophylactic treatment within the previous three months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırköy Prof. Dr. Mazhar Osman Ruh Sağlığı ve Sinir Hastalıkları Eğitim ve Araştırma Hastanesi
Istanbul
About this study
Official title: Evaluation of the Effect of Acceptance and Commitment Therapy-Based Group Psychotherapy on Depression, Anxiety and Quality of Life in Patients Diagnosed With Chronic Headache
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:
Read more
- In adults diagnosed with chronic headache, can ACT-based group psychotherapy reduce depression and anxiety symptoms and improve quality of life and daily functioning?
- In adults diagnosed with chronic headache, can ACT-based group psychotherapy improve psychological flexibility and reduce repetitive negative thinking? The study enrolled 72 adults aged 18 to 65 years who have been diagnosed with chronic headache and are receiving medication treatment for chronic headache.
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.
Read the detailed description
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.
- Conditions
- Chronic Headache
- Being tested
- Acceptance and Commitment Therapy-Based Group Psychotherapy, Psychoeducation
- Keywords
- Acceptance and Commitment Therapy, Depression, Anxiety, Group Psychotherapy, Psychological Flexibility, Chronic Headache
- Medical subject headings
- Headache Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy-Based Group PsychotherapyBehavioural
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.
PsychoeducationBehavioural
Psychoeducation is delivered in four weekly group sessions, each lasting approximately 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| ACT-Based Group Psychotherapy | Experimental | 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. Receives: Behavioral: Acceptance and Commitment Therapy-Based Group Psychotherapy |
| Psychoeducation | Active comparator | Psychoeducation is delivered in four weekly group sessions, each lasting approximately 90 minutes. Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (before the first group session), at the end of the fourth session (up to 1 month) and 1 month after the final session
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (before the first group session), at the end of the fourth session (up to 1 month) and 1 month after the final session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start12 Mar 2026
- Primary completion19 Nov 2026 (estimated)
- Study completion19 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906119
- Sponsor's protocol ID
- 2026/80
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Acceptance and Commitment Therapy-Based Group Psychotherapy on Depression, Anxiety and Quality of Life in Patients Diagnosed With Chronic Headache
- ClinicalTrials.gov ID
- NCT07906119
- Acronym / sponsor ID
- 2026/80
- Conditions
- Chronic Headache
- Keywords
- Acceptance and Commitment Therapy, Depression, Anxiety, Group Psychotherapy, Psychological Flexibility, Chronic Headache
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 19 Nov 2026 (estimated)
- Study completion
- 19 Nov 2026 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- In adults diagnosed with chronic headache, can ACT-based group psychotherapy reduce depression and anxiety symptoms and improve quality of life and daily functioning?
- In adults diagnosed with chronic headache, can ACT-based group psychotherapy improve psychological flexibility and reduce repetitive negative thinking? The study enrolled 72 adults aged 18 to 65 years who have been diagnosed with chronic headache and are receiving medication treatment for chronic headache.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT-Based Group Psychotherapy | Experimental | Behavioral: Acceptance and Commitment Therapy-Based Group PsychotherapyParticipants 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. |
| Psychoeducation | Active comparator | Behavioral: PsychoeducationPsychoeducation is delivered in four weekly group sessions, each lasting approximately 90 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years.
- Diagnosis of chronic headache according to ICHD-3 criteria.
- Currently receiving pharmacotherapy for chronic headache.
- Literate.
- Willingness to participate in the four-session weekly psychotherapy program and the study.
Key exclusion criteria (4 listed)
- Presence of visual and/or hearing impairment.
- Currently receiving psychotherapy.
- Presence of any psychotic disorder, an active mood episode, intellectual disability, dementia, or another condition interfering with the interview.
- Initiation of a new psychiatric or neurological treatment during the study, or a change in medication or dose of prophylactic treatment within the previous three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment Therapy-Based Group PsychotherapyThe 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. | Behavioural | ACT-Based Group Psychotherapy |
| PsychoeducationPsychoeducation is delivered in four weekly group sessions, each lasting approximately 90 minutes. | Behavioural | Psychoeducation |
Primary outcome
Change in Depression and Anxiety Levels Assessed by the Depression Anxiety Stress Scales-21 (DASS-21)
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
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.
Change in Headache Impact Assessed by the Headache Impact Test-6 (HIT-6)
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
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.
Change in Health-Related Quality of Life Assessed by the Short Form-12 Health Survey (SF-12)
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
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.
5 secondary outcomes
Change in Psychological Flexibility and Experiential Avoidance Assessed by the Acceptance and Action Questionnaire-II (AAQ-II)
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)
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)
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
Time frame: 1 month after the final session
Change in Repetitive Negative Thinking Assessed by the Perseverative Thinking Questionnaire (PTQ)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy-Based Group Psychotherapy and Psychoeducation in people with Chronic Headache, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression and Anxiety Levels Assessed by the Depression Anxiety Stress Scales-21 (DASS-21) (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.