- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07396363
Psychoeducational Psychotherapy in Adolescent Bipolar Disorder
February 6, 2026 updated by: Ezgi Karagoz Tanigor M.D., Dokuz Eylul University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
İzmir
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Izmir, İzmir, Turkey (Türkiye), 35620
- Dokuz Eylül University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients between the ages of 12 and 18 years who were diagnosed with BD (Bipolar Disorder)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
No Intervention: Control
Control group who received routine treatment and care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wisconsin Card Sorting Test
Time Frame: 12 weeks
|
WCST is a test reflecting set-shifting which is defined as the flexibility in responses due to changes in reinforcement
|
12 weeks
|
|
The Pediatric Quality of life Inventory (PedsQL)
Time Frame: 12 weeks
|
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
|
12 weeks
|
|
Affective Reactivity Index-Child and Parent Forms
Time Frame: 12 weeks
|
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.
|
12 weeks
|
|
Young Mania Rating Scale
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Bauer 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 24, 2017
Primary Completion (Actual)
December 23, 2022
Study Completion (Actual)
December 23, 2022
Study Registration Dates
First Submitted
February 1, 2026
First Submitted That Met QC Criteria
February 1, 2026
First Posted (Actual)
February 9, 2026
Study Record Updates
Last Update Posted (Actual)
February 10, 2026
Last Update Submitted That Met QC Criteria
February 6, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 354-SBKAEK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Can not be shared due to ethical concerns
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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