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Completed

NCT Number: NCT07396363

Psychoeducational Psychotherapy in Adolescent Bipolar Disorder

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.

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Key information

Conditions

Bipolar Disorder (BD) Behavior Bipolar Disorder Bipolar and Related Disorders Emotional Regulation Mental Disorders Mood Disorders Self-Control Social Behavior

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University

Izmir, İzmir, 35620, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychoeducational Psychotherapy (PEP)

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Feb 9, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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