Generalized Anxiety DisorderNCT06972563
The Effect of Psychoeducation Based on Acceptance and Commitment Therapy Applied to Patients Diagnosed With Generalized Anxiety Disorder on Cognitive Avoidance Levels and Coping Attitudes
A study testing Psychoeducation Based on Acceptance and Commitment Therapy Applied to Patients Diagnosed with Generalized Anxiety Disorder and The initiative was not implemented. in people with Generalized Anxiety Disorder, run by Arzu Çalışkan at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted to determine the effects of acceptance and commitment therapy-based psychoeducation on cognitive avoidance levels and coping attitudes in patients diagnosed with generalized anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Psychoeducation Based on Acceptance and Commitment Therapy Applied to Patients Diagnosed with Generalized Anxiety Disorder and The initiative was not implemented.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2024to 25 Jun 2025
- 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
- Having been diagnosed with generalized anxiety disorder according to DSM-5 diagnostic criteria and receiving outpatient treatment
- Being literate
- Having no problems understanding or speaking Turkish
- Being in the 18-65 age group
- Having not received such training in the last 6 months
Who cannot join
- Those diagnosed with another comorbid mental illness Patients with a mental condition that makes cooperation impossible, such as intellectual disability or memory impairment
- The illiterate
- Patients who do not consent to be interviewed
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hatay Eğitim ve Araştırma Hastanesi
Hatay, Antakya, 31030
About this study
This study will be conducted to determine the effects of acceptance and commitment therapy-based psychoeducation on cognitive avoidance levels and coping attitudes in patients diagnosed with generalized anxiety disorder.
H0: Acceptance and commitment therapy-based psychoeducation has no effect on the cognitive avoidance levels and coping attitudes of patients diagnosed with generalized anxiety disorder.
Read more
H1: Acceptance and commitment therapy-based psychoeducation reduces the cognitive avoidance levels of patients diagnosed with generalized anxiety disorder.
H2: Acceptance and commitment therapy-based psychoeducation affects the coping attitudes of patients diagnosed with generalized anxiety disorder.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Psychoeducation Based on Acceptance and Commitment Therapy Applied to Patients Diagnosed with Generalized Anxiety Disorder, The initiative was not implemented.
- Keywords
- Generalized Anxiety Disorder, Acceptance and Commitment Therapy, Cognitive Avoidance, Coping Attitudes
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation Based on Acceptance and Commitment Therapy Applied to Patients Diagnosed with Generalized Anxiety DisorderOther
Psychoeducation Based on Acceptance and Commitment Therapy Applied to Patients Diagnosed with Generalized Anxiety Disorder
The initiative was not implemented.Other
The initiative was not implemented.
| Study group | Role | What they receive |
|---|---|---|
| Experiment | Experimental | Psychoeducation Based on Acceptance and Commitment Therapy Applied to Patients Diagnosed with Generalized Anxiety Disorder Receives: Other: Psychoeducation Based on Acceptance and Commitment Therapy Applied to Patients Diagnosed with Generalized Anxiety Disorder |
| Control | Other | The initiative was not implemented. Receives: Other: The initiative was not implemented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the effect of cognitive avoidance levels of patients diagnosed with generalized anxiety disorder
Patients answered cognitive avoidance scale. Cognitive Avoidance Scale (Cope) measures cognitive avoidance strategies. COA is a self-assessment type scale. The five (1-5) point Likert-type scale (1-strongly disagree, 5-strongly agree) measures 25 items of COA. The score that can be obtained from the scale is between 12 and 125. In order to calculate the total score, it is necessary to sum the answers given to all items. A high score indicates that a cognitive avoidance strategy is used in the face of problems.
Measured: 1 month
Secondary outcomes (1)
coping attitudes of patients diagnosed with generalized anxiety disorder
The scale is a 4-point Likert-type scale. When scoring the items, 1 point is given for "I Never Do This", 2 points for "I Rarely Do This", 3 points for "I Do This" and 4 points for "I Often Do This". There are no negative items in the scale. The highest score that can be obtained from the scale is 160, the lowest score is 40. A high score obtained from the scale means a high level of coping attitude, and a low score means a low level of coping attitude.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start25 Jun 2024
- Primary completion25 Jul 2024
- Study completion25 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arzu Çalışkan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arzu Çalışkan, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972563
- Sponsor's protocol ID
- Gaziantep Üniversitesi
- Status last verified
- Apr 2025
- First submitted
- 25 Sep 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No detailed permission was obtained from the owners of the collected data.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Psychoeducation Based on Acceptance and Commitment Therapy Applied to Patients Diagnosed With Generalized Anxiety Disorder on Cognitive Avoidance Levels and Coping Attitudes
- ClinicalTrials.gov ID
- NCT06972563
- Acronym / sponsor ID
- Gaziantep Üniversitesi
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized Anxiety Disorder, Acceptance and Commitment Therapy, Cognitive Avoidance, Coping Attitudes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Arzu ÇalışkanUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 25 Jun 2025 (estimated)
- First posted
- 15 May 2025 (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.
This study will be conducted to determine the effects of acceptance and commitment therapy-based psychoeducation on cognitive avoidance levels and coping attitudes in patients diagnosed with generalized anxiety disorder.
H0: Acceptance and commitment therapy-based psychoeducation has no effect on the cognitive avoidance levels and coping attitudes of patients diagnosed with generalized anxiety disorder.
H1: Acceptance and commitment therapy-based psychoeducation reduces the cognitive avoidance levels of patients diagnosed with generalized anxiety disorder.
H2: Acceptance and commitment therapy-based psychoeducation affects the coping attitudes of patients diagnosed with generalized anxiety disorder.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment | Experimental | Other: Psychoeducation Based on Acceptance and Commitment Therapy Applied to Patients Diagnosed with Generalized Anxiety DisorderPsychoeducation Based on Acceptance and Commitment Therapy Applied to Patients Diagnosed with Generalized Anxiety Disorder |
| Control | Other | Other: The initiative was not implemented.The initiative was not implemented. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having been diagnosed with generalized anxiety disorder according to DSM-5 diagnostic criteria and receiving outpatient treatment
- Being literate
- Having no problems understanding or speaking Turkish
- Being in the 18-65 age group
- Having not received such training in the last 6 months
Key exclusion criteria (3 listed)
- Those diagnosed with another comorbid mental illness Patients with a mental condition that makes cooperation impossible, such as intellectual disability or memory impairment
- The illiterate
- Patients who do not consent to be interviewed
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 |
|---|---|---|
| Psychoeducation Based on Acceptance and Commitment Therapy Applied to Patients Diagnosed with Generalized Anxiety DisorderPsychoeducation Based on Acceptance and Commitment Therapy Applied to Patients Diagnosed with Generalized Anxiety Disorder | Other | Experiment |
| The initiative was not implemented.The initiative was not implemented. | Other | Control |
Primary outcome
Measuring the effect of cognitive avoidance levels of patients diagnosed with generalized anxiety disorder
Time frame: 1 month
Patients answered cognitive avoidance scale. Cognitive Avoidance Scale (Cope) measures cognitive avoidance strategies. COA is a self-assessment type scale. The five (1-5) point Likert-type scale (1-strongly disagree, 5-strongly agree) measures 25 items of COA. The score that can be obtained from the scale is between 12 and 125. In order to calculate the total score, it is necessary to sum the answers given to all items. A high score indicates that a cognitive avoidance strategy is used in the face of problems.
1 secondary outcome
coping attitudes of patients diagnosed with generalized anxiety disorder
Time frame: 1 month
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 15 May 2025.
- Individual participant dataSharing planned: No. No detailed permission was obtained from the owners of the collected data.
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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 Psychoeducation Based on Acceptance and Commitment Therapy Applied to Patients Diagnosed with Generalized Anxiety Disorder and The initiative was not implemented. in people with Generalized Anxiety Disorder, run by Arzu Çalışkan 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 3 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 15 May 2025. 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?
Measuring the effect of cognitive avoidance levels of patients diagnosed with generalized anxiety disorder (time frame: 1 month). 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 15 May 2025.