Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Headache

Keywords

Acceptance and Commitment TherapyDepressionAnxietyGroup PsychotherapyPsychological FlexibilityChronic Headache

Outcome Measures

Primary Outcomes (3)

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.
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.
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)
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)
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)
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
1 month after the final session
Change in Repetitive Negative Thinking Assessed by the Perseverative Thinking Questionnaire (PTQ)
Baseline (before the first group session), at the end of the fourth session (up to 1 month) and 1 month after the final session

Study Arms (2)

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.

Behavioral: Acceptance and Commitment Therapy-Based Group Psychotherapy

Psychoeducation

ACTIVE COMPARATOR

Psychoeducation is delivered in four weekly group sessions, each lasting approximately 90 minutes.

Behavioral: Psychoeducation

Interventions

Acceptance and Commitment Therapy-Based Group PsychotherapyBehavioral

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.

ACT-Based Group Psychotherapy

PsychoeducationBehavioral

Psychoeducation is delivered in four weekly group sessions, each lasting approximately 90 minutes.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age between 18 and 65 years.
Diagnosis of chronic headache according to ICHD-3 criteria.

Sponsors & Collaborators

Saglik Bilimleri Universitesi
Otherlead

Study Sites (1)

Bakırköy Prof. Dr. Mazhar Osman Ruh Sağlığı ve Sinir Hastalıkları Eğitim ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)

MeSH Terms

Conditions

Headache DisordersDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavioral SymptomsBehaviorMental Disorders

Enrollment

72 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 17, 2026

First Posted

October 30, 2026

Study Start

March 12, 2026

Actual (reported)

Acceptance and Commitment Therapy-Based Group Psychotherapy for Chronic Headache

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (5)

Study Arms (2)

ACT-Based Group Psychotherapy

Psychoeducation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (5)

Study Arms (2)

ACT-Based Group Psychotherapy

Psychoeducation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations