Bipolar Disorder (BD)NCT07396363
Psychoeducational Psychotherapy in Adolescent Bipolar Disorder
A study testing Psychoeducational psychotherapy (PEP) in people with Bipolar Disorder (BD), run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated the effects of psychoeducational psychotherapy (PEP) on neurocognitive functions, symptomatology, quality of life, and emotion regulation in euthymic adolescents with bipolar disorder (BD). Thirty-two adolescents with BD were randomized, with 16 receiving PEP. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Bipolar Disorder (BD)
- What is being tested?
- Psychoeducational psychotherapy (PEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jan 2017to 23 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients between the ages of 12 and 18 years who were diagnosed with BD (Bipolar Disorder)
Who cannot join
- Presence of chronic medical disorders, a clinical diagnosis of autism spectrum disorder, mental retardation or intellectual disability (according to developmental/academic history and clinical examination), past or current epilepsy, brain injury, and cerebral palsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Psychoeducational Psychotherapy on Neurocognitive Functions, Quality of Life, And Emotion Regulation in Adolescents Diagnosed With Bipolar Disorder: A Randomized Controlled Trial
This study evaluated the effects of psychoeducational psychotherapy (PEP) on neurocognitive functions, symptomatology, quality of life, and emotion regulation in euthymic adolescents with bipolar disorder (BD). Thirty-two adolescents with BD were randomized, with 16 receiving PEP. Assessments included the Wisconsin Card Sorting Test, Stroop Test, Pediatric Quality-of-Life Inventory, Difficulties in Emotion Regulation Scale (DERS), Affective Reactivity Index, Young Mania Rating Scale, and Children's Depression Rating Scale.
Read the detailed description
This study aimed to examine the impact of PEP on neurocognitive performance, symptom levels, quality of life, and emotion regulation among euthymic adolescents diagnosed with BD. A total of 32 adolescents meeting diagnostic criteria for BD were randomly assigned to either an intervention group (n = 16), which received PEP, or a control group receiving standard care. Participants were evaluated using a comprehensive assessment battery that included the Wisconsin Card Sorting Test and the Stroop Test to measure executive functioning; the Pediatric Quality-of-Life Inventory to assess well-being; the DERS and the Affective Reactivity Index for emotional functioning; and the Young Mania Rating Scale and Children's Depression Rating Scale to evaluate mood symptoms.
- Conditions
- Bipolar Disorder (BD)
- Being tested
- Psychoeducational psychotherapy (PEP)
- Keywords
- Bipolar Disorder, emotion regulation, neurocognition, quality of life, irritability
- Medical subject headings
- Bipolar Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational psychotherapy (PEP)Behavioural
PEP is a structured, manualized, family-focused psychotherapy based on cognitive behavioral therapy (CBT). Participants were invited to participate in weekly parent and child sessions over a 12-week period. Each session lasted approximately 45-50 minutes, with a total of 24 sessions available throughout the trial. Parental involvement was incorporated into every PEP session, with parents joining for 5-10 minutes at the beginning of each child session to discuss the child's progress and for another 5-10 minutes at the end to review newly introduced material.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducational psychotherapy (PEP) | Experimental | PEP is a structured, manualized, family-focused psychotherapy based on cognitive behavioral therapy (CBT). Participants were invited to participate in weekly parent and child sessions over a 12-week period. Each session lasted approximately 45-50 minutes, with a total of 24 sessions available throughout the trial. Parental involvement was incorporated into every PEP session, with parents joining for 5-10 minutes at the beginning of each child session to discuss the child's progress and for another 5-10 minutes at the end to review newly introduced material. Receives: Behavioral: Psychoeducational psychotherapy (PEP) |
| Control | No intervention | Control group who received routine treatment and care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Difficulties in Emotion Regulation Scale (DERS)
The Difficulties in Emotion Regulation Scale (DERS) assesses emotion regulation (ER) problems in adolescents across six domains: goals, strategies, impulsivity, awareness, clarity, and non-acceptance. Higher scores reflect greater ER difficulties. The Turkish version demonstrated good reliability and validity.
Measured: 12 weeks
Secondary outcomes (4)
Wisconsin Card Sorting Test
WCST is a test reflecting set-shifting which is defined as the flexibility in responses due to changes in reinforcement
Measured: 12 weeks
The Pediatric Quality of life Inventory (PedsQL)
The PedsQL scale was used to assess problems within the multidimensional health-related quality of life in the last month. This is a modular instrument that is designed to measure health-related quality of life (HRQOL) among children and adolescents aged 2 to 18 years
Measured: 12 weeks
Affective Reactivity Index-Child and Parent Forms
The Affective Reactivity Index-Child and Parent Forms is a scale developed for the evaluation and monitoring of irritability according to the reports of children and parents. Total scores range from 0 to 12, with higher scores indicating greater levels of irritability and thus a worse clinical outcome.
Measured: 12 weeks
Young Mania Rating Scale
The Young Mania Rating Scale is an eleven item, likert-type scale that evaluates the symptoms of mania over the previous 48 hours or week, according to clinical observations and patient reports.The total score obtained from the scale ranges from 0 to 60, with higher scores indicating more severe manic symptoms.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start24 Jan 2017
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar Disorder (BD)Studies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Karagoz Tanigor M.D., Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396363
- Sponsor's protocol ID
- 354-SBKAEK
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Can not be shared due to ethical concerns
Publications
Kowatch RA, Fristad M, Birmaher B, Wagner KD, Findling RL, Hellander M; Child Psychiatric Workgroup on Bipolar Disorder. Treatment guidelines for children and adolescents with bipolar disorder. J Am Acad Child Adolesc Psychiatry. 2005 Mar;44(3):213-35. doi: 10.1097/00004583-200503000-00006.
PubMed 15725966Bauer IE, Frazier TW, Meyer TD, Youngstrom E, Zunta-Soares GB, Soares JC. Affective Processing in Pediatric Bipolar Disorder and Offspring of Bipolar Parents. J Child Adolesc Psychopharmacol. 2015 Nov;25(9):684-90. doi: 10.1089/cap.2015.0076. Epub 2015 Oct 15.
PubMed 26468988
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Psychoeducational Psychotherapy on Neurocognitive Functions, Quality of Life, And Emotion Regulation in Adolescents Diagnosed With Bipolar Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07396363
- Acronym / sponsor ID
- 354-SBKAEK
- Conditions
- Bipolar Disorder (BD)
- Keywords
- Bipolar Disorder, emotion regulation, neurocognition, quality of life, irritability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 9 Feb 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.
This study evaluated the effects of psychoeducational psychotherapy (PEP) on neurocognitive functions, symptomatology, quality of life, and emotion regulation in euthymic adolescents with bipolar disorder (BD). Thirty-two adolescents with BD were randomized, with 16 receiving PEP. Assessments included the Wisconsin Card Sorting Test, Stroop Test, Pediatric Quality-of-Life Inventory, Difficulties in Emotion Regulation Scale (DERS), Affective Reactivity Index, Young Mania Rating Scale, and Children's Depression Rating Scale.
Detailed description
This study aimed to examine the impact of PEP on neurocognitive performance, symptom levels, quality of life, and emotion regulation among euthymic adolescents diagnosed with BD. A total of 32 adolescents meeting diagnostic criteria for BD were randomly assigned to either an intervention group (n = 16), which received PEP, or a control group receiving standard care. Participants were evaluated using a comprehensive assessment battery that included the Wisconsin Card Sorting Test and the Stroop Test to measure executive functioning; the Pediatric Quality-of-Life Inventory to assess well-being; the DERS and the Affective Reactivity Index for emotional functioning; and the Young Mania Rating Scale and Children's Depression Rating Scale to evaluate mood symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducational psychotherapy (PEP) | Experimental | Behavioral: Psychoeducational psychotherapy (PEP)PEP is a structured, manualized, family-focused psychotherapy based on cognitive behavioral therapy (CBT). Participants were invited to participate in weekly parent and child sessions over a 12-week period. Each session lasted approximately 45-50 minutes, with a total of 24 sessions available throughout the trial. Parental involvement was incorporated into every PEP session, with parents joining for 5-10 minutes at the beginning of each child session to discuss the child's progress and for another 5-10 minutes at the end to review newly introduced material. |
| Control | No intervention | –Control group who received routine treatment and care. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients between the ages of 12 and 18 years who were diagnosed with BD (Bipolar Disorder)
Key exclusion criteria (1 listed)
- Presence of chronic medical disorders, a clinical diagnosis of autism spectrum disorder, mental retardation or intellectual disability (according to developmental/academic history and clinical examination), past or current epilepsy, brain injury, and cerebral palsy
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 |
|---|---|---|
| Psychoeducational psychotherapy (PEP)PEP is a structured, manualized, family-focused psychotherapy based on cognitive behavioral therapy (CBT). Participants were invited to participate in weekly parent and child sessions over a 12-week period. Each session lasted approximately 45-50 minutes, with a total of 24 sessions available throughout the trial. Parental involvement was incorporated into every PEP session, with parents joining for 5-10 minutes at the beginning of each child session to discuss the child's progress and for another 5-10 minutes at the end to review newly introduced material. | Behavioural | Psychoeducational psychotherapy (PEP) |
Primary outcome
the Difficulties in Emotion Regulation Scale (DERS)
Time frame: 12 weeks
The Difficulties in Emotion Regulation Scale (DERS) assesses emotion regulation (ER) problems in adolescents across six domains: goals, strategies, impulsivity, awareness, clarity, and non-acceptance. Higher scores reflect greater ER difficulties. The Turkish version demonstrated good reliability and validity.
4 secondary outcomes
Wisconsin Card Sorting Test
Time frame: 12 weeks
The Pediatric Quality of life Inventory (PedsQL)
Time frame: 12 weeks
Affective Reactivity Index-Child and Parent Forms
Time frame: 12 weeks
Young Mania Rating Scale
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Results publication: PubMed 15725966Kowatch RA, Fristad M, Birmaher B, Wagner KD, Findling RL, Hellander M; Child Psychiatric Workgroup on Bipolar Disorder. Treatment guidelines for children and adolescents with bipolar disorder. J Am Acad Child Adolesc Psychiatry. 2005 Mar;44(3):213-35. doi: 10.1097/00004583-200503000-00006.
- Results publication: PubMed 26468988Bauer IE, Frazier TW, Meyer TD, Youngstrom E, Zunta-Soares GB, Soares JC. Affective Processing in Pediatric Bipolar Disorder and Offspring of Bipolar Parents. J Child Adolesc Psychopharmacol. 2015 Nov;25(9):684-90. doi: 10.1089/cap.2015.0076. Epub 2015 Oct 15.
- Individual participant dataSharing planned: No. Can not be shared due to ethical concerns
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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 Psychoeducational psychotherapy (PEP) in people with Bipolar Disorder (BD), run by Dokuz Eylul University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the Difficulties in Emotion Regulation Scale (DERS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07396363, which also lists 2 linked publications.
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 10 Feb 2026.