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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey (Türkiye)
    • İzmir
      • Izmir, İzmir, Turkey (Türkiye), 35620
        • Dokuz Eylul 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
No Intervention: Control
Control group who received routine treatment and care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dokuz Eylul University

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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