Obsessive - Compulsive DisorderNCT06942494
Effect of a Family-Based CBT Self-Help Intervention for Adolescents With OCD
A study testing conventional medical treatment (TAU) and Family-Based Self-help Book for Adolescents with Obsessive-Compulsive Disorder in people with Obsessive - Compulsive Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if self-help book can be used to treat obsessive-compulsive disorder (OCD) in adolescents aged 10 to 17. The main questions it aims to answer are: Can adolescents and their parents effectively reduce the severity of the obsessive-compulsive symptoms in adolescents who are… Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive - Compulsive Disorder
- What is being tested?
- conventional medical treatment (TAU) and Family-Based Self-help Book for Adolescents with Obsessive-Compulsive Disorder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2025to 31 Dec 2027
- 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 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 10 and 17 years
- Satisfied with the diagnostic criteria for OCD in DSM-5
- 16≤CY-BOCS score ≤23
- Taking medication stably for 6 weeks
- Education level ⩾6 years
- At least one parent can accompany the patients throughout the entire intervention process
Show all 9Show fewer
- The patient and the participating parent have sufficient reading and writing skills to complete the treatment intervention
- The patient and the participating parent have adequate auditory and visual abilities skills to complete the necessary examinations for the study
- Right-handed (this criterion is for fMRI subjects only) (8) Subjects and their guardians understood the study and signed informed consent.
Who cannot join
- Obsessive-compulsive symptoms were too severe to participate in the experiment(CY-BOCS score ≥24)
- High risk of suicide
- Comorbid brain organic diseases, severe somatic diseases, learning disabilities, autism spectrum disorders, schizophrenia spectrum and other psychotic disorders, bipolar disorder, severe eating disorders, or substance abuse
- Completed a Cognitive Behavioral Therapy (CBT) course for OCD within the past 12 months.
- An IQ lower than 80
- Currently undergoing other psychological/physical treatments
- Uncooperative or unable to complete treatment
- With metal implants in the body, such as pacemakers, intracranial silver clips, metal dentures, arterial stents, arterial clips, joint metal fixation, or other metal implants, etc. (this criterion is for fMRI subjects only)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Xuhui, Shanghai Municipality, 20030
Qing Fan, Doctor, +86 13916436072, fanqing_98@vip.sina.com
About this study
Official title: Effect of a Family-Based Cognitive Behavioral Therapy Self-Help Intervention for Adolescents With Obsessive-Compulsive Disorder：A Randomized Controlled Trial
The goal of this clinical trial is to learn if self-help book can be used to treat obsessive-compulsive disorder (OCD) in adolescents aged 10 to 17. The main questions it aims to answer are:
Can adolescents and their parents effectively reduce the severity of the obsessive-compulsive symptoms in adolescents who are already stably taking medications through self-help books? What are the characteristics of adolescents who are best suited to use self-help intervention book to treat obsessive-compulsive symptoms?
Read more
Researchers will compare the use of a self-help books plus medication with medication alone to see if the combination of the self-help intervention and drug treatment can improve the obsessive-compulsive symptoms of adolescents more effectively.
Participants will:
- Read one chapter of a self-help book and complete the corresponding exercise each week for 12 weeks
- Visit the clinic before and after intervention for checkups and tests
- Conditions
- Obsessive - Compulsive Disorder
- Being tested
- conventional medical treatment (TAU), Family-Based Self-help Book for Adolescents with Obsessive-Compulsive Disorder
- Keywords
- Obsessive - Compulsive Disorder, Adolescents, Bibliotherapy
- Medical subject headings
- Compulsive Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional medical treatment (TAU)Drug
In this study, the investigators use selective serotonin reuptake inhibitors (SSRIs, i.e., sertraline, fluoxetine and fluvoxamine)and tricyclic drugs(i.e., clomipramine) approved by the State Food and Drug Administration (CFDA) for the treatment of OCD in children and adolescents. The drugs used in this study are commonly used in clinical practice and have a good safety profile. The maximum dosage shall not exceed the maximum dosage prescribed in the instruction manual, or the maximum dosage tolerated by the patients.
Family-Based Self-help Book for Adolescents with Obsessive-Compulsive DisorderBehavioural
The self-help book used in this study was independently developed by members of our research team. Its content is based on Exposure and Response Prevention (ERP). Adolescent patients with OCD will be instructed to read one chapter of the self-help book each week and complete the corresponding exercises. This 12-week intervention will involve self-guided practice conducted by the adolescent and their family members.Throughout the intervention period, adolescents and their caregivers may contact the therapist via WeChat to ask questions and upload records of their completed exercises. The therapist will respond to any questions within 48 hours by sending written messages via WeChat, with each family receiving no more than 30 minutes of such written guidance per week. All therapists will be required to keep a weekly log of the time spent providing guidance to each participating family.If a participating family does not initiate contact, the therapist will not provide proactive guidance.
| Study group | Role | What they receive |
|---|---|---|
| Family-Based Self-Help Intervention Group | Experimental | Adolescents with OCD in this group will continue their stable pharmacological treatment for at least six weeks prior to enrollment. After baseline assessment, they will receive a 12-week structured cognitive behavioral therapy (CBT)-based self-help intervention, specifically designed for chinese adolescents and involving family participation. After the 12-week intervention, participants will enter a 3-month follow-up phase, during which no new therapeutic components will be introduced, but data on symptom maintenance and treatment adherence will be collected.During the 12-week intervention they will continue with the medications they already have. Receives: Behavioral: Family-Based Self-help Book for Adolescents with Obsessive-Compulsive Disorder |
| Treatment-As-Usual Waitlist Control Group | Active comparator | Adolescents with OCD in this group will be similarly required to receive at least six weeks of stabilizing medication prior to enrollment. In this group, participants will be treated as usual. Namely, they will continue with the medications they already have with no changes throughout the 12-week intervention period. No psychological intervention will be provided during this phase. After completing the follow-up assessment at week 12, participants will be offered access to the CBT-based self-help book as a delayed intervention. Receives: Drug: conventional medical treatment (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) Total Score
The CY-BOCS is a clinician-rated instrument used to assess the severity of obsessive-compulsive symptoms in children and adolescents, which has good reliability and validity.. The total score ranges from 0 to 40, with higher scores indicating greater severity. The primary outcome is the change in CY-BOCS total score from baseline to each follow-up point.
Measured: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
Secondary outcomes (5)
Change in Children's Depression Inventory (CDI) Total Score
The CDI is currently one of the most widely used self-assessment tools for evaluating depressive symptoms in children and adolescents. The scale consists of 27 multiple-choice items that assess a range of common depressive symptoms in youth, including sadness, hopelessness, suicidal ideation, and disturbances in sleep and appetite. Each item offers three response options reflecting increasing levels of symptom severity, scored as 0, 1, or 2.Scores range from 0 to 54, with higher scores indicating more severe depressive symptoms.The Chinese version used in the current study has demonstrated good psychometric properties, including a Cronbach's alpha of 0.85, a split-half reliability coefficient of 0.71, and a test-retest reliability coefficient of 0.75.
Measured: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
Change in Obsessive-Compulsive Inventory - Child Version (OCI-CV) Total Score
The Obsessive-Compulsive Inventory-Child Version (OCI-CV) is a multidimensional self-report scale developed by Foa and colleagues to assess the severity of obsessive-compulsive symptoms in children and adolescents aged 7 to 17. The scale consists of 21 items covering six symptom dimensions: Doubting/Checking, Obsessing, Hoarding, Washing, Ordering, and Neutralizing. Each item is rated on a 3-point Likert scale: 0 = Never, 1 = Sometimes, 2 = Always. The Chinese version of the scale used in current study has demonstrated strong psychometric properties and has been validated in international clinical samples. The internal consistency of the total scale was 0.856, and the internal consistency coefficients for the subscales ranged from 0.462 to 0.747. Test-retest reliability coefficients ranged from 0.532 to 0.758.The outcome is measured by the change in total score from baseline.
Measured: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
Change in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score
The Screen for Child Anxiety Related Emotional Disorders (SCARED) is a self-report screening tool developed to assess anxiety symptoms in children and adolescents aged 9 to 18. It is widely used in clinical settings, research, and epidemiological studies as a supplemental tool for the diagnosis of anxiety-related disorders. The SCARED scale assesses five factors: somatization, generalized anxiety, separation anxiety, social phobia, and school phobia. Items are rated on a 3-point Likert scale: 0 = not true or hardly ever true, 1 = somewhat true or sometimes true, and 2 = very true or often true.
The psychometric properties of the Chinese version used in the present study include test-retest reliability coefficients ranging from 0.567 to 0.608, split-half reliability of 0.88, and Cronbach's alpha coefficients ranging from 0.43 to 0.89. Item-total correlations ranged from 0.43 to 0.74.
Measured: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
Clinical Global Impression - Improvement (CGI-I)
The Clinical Global Impression (CGI) scale is a clinician-rated tool commonly used in psychiatric treatment studies to subjectively assess the severity of illness, treatment response, and overall therapeutic efficacy. It was developed by the Early Clinical Drug Evaluation Program (ECDEU) research group for clinical trials sponsored by the National Institute of Mental Health (NIMH). The CGI provides a clinician-based evaluation framework for determining the severity of a patient's symptoms and monitoring treatment progress over time. The CGI-I is used to assess overall improvement relative to baseline, scored from 1 (very much improved) to 7 (very much worse).
Measured: Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
Clinical Global Impression - Severity (CGI-S)
The CGI-S is a clinician-rated measure of the severity of the patient's illness, scored from 1 (normal) to 7 (among the most extremely ill).
Measured: Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start30 Apr 2025
- Primary completionAug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive - Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qing Fan, Doctor, Study chair, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942494
- Sponsor's protocol ID
- 2024-112
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Family-Based Cognitive Behavioral Therapy Self-Help Intervention for Adolescents With Obsessive-Compulsive Disorder：A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06942494
- Acronym / sponsor ID
- 2024-112
- Conditions
- Obsessive - Compulsive Disorder
- Keywords
- Obsessive - Compulsive Disorder, Adolescents, Bibliotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Apr 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.
The goal of this clinical trial is to learn if self-help book can be used to treat obsessive-compulsive disorder (OCD) in adolescents aged 10 to 17. The main questions it aims to answer are:
Can adolescents and their parents effectively reduce the severity of the obsessive-compulsive symptoms in adolescents who are already stably taking medications through self-help books? What are the characteristics of adolescents who are best suited to use self-help intervention book to treat obsessive-compulsive symptoms?
Researchers will compare the use of a self-help books plus medication with medication alone to see if the combination of the self-help intervention and drug treatment can improve the obsessive-compulsive symptoms of adolescents more effectively.
Participants will:
- Read one chapter of a self-help book and complete the corresponding exercise each week for 12 weeks
- Visit the clinic before and after intervention for checkups and tests
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family-Based Self-Help Intervention Group | Experimental | Behavioral: Family-Based Self-help Book for Adolescents with Obsessive-Compulsive DisorderAdolescents with OCD in this group will continue their stable pharmacological treatment for at least six weeks prior to enrollment. After baseline assessment, they will receive a 12-week structured cognitive behavioral therapy (CBT)-based self-help intervention, specifically designed for chinese adolescents and involving family participation. After the 12-week intervention, participants will enter a 3-month follow-up phase, during which no new therapeutic components will be introduced, but data on symptom maintenance and treatment adherence will be collected.During the 12-week intervention they will continue with the medications they already have. |
| Treatment-As-Usual Waitlist Control Group | Active comparator | Drug: conventional medical treatment (TAU)Adolescents with OCD in this group will be similarly required to receive at least six weeks of stabilizing medication prior to enrollment. In this group, participants will be treated as usual. Namely, they will continue with the medications they already have with no changes throughout the 12-week intervention period. No psychological intervention will be provided during this phase. After completing the follow-up assessment at week 12, participants will be offered access to the CBT-based self-help book as a delayed intervention. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Age between 10 and 17 years
- Satisfied with the diagnostic criteria for OCD in DSM-5
- 16≤CY-BOCS score ≤23
- Taking medication stably for 6 weeks
- Education level ⩾6 years
Key exclusion criteria (8 listed)
- Obsessive-compulsive symptoms were too severe to participate in the experiment(CY-BOCS score ≥24)
- High risk of suicide
- Comorbid brain organic diseases, severe somatic diseases, learning disabilities, autism spectrum disorders, schizophrenia spectrum and other psychotic disorders, bipolar disorder, severe eating disorders, or substance abuse
- Completed a Cognitive Behavioral Therapy (CBT) course for OCD within the past 12 months.
- An IQ lower than 80
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 |
|---|---|---|
| conventional medical treatment (TAU)In this study, the investigators use selective serotonin reuptake inhibitors (SSRIs, i.e., sertraline, fluoxetine and fluvoxamine)and tricyclic drugs(i.e., clomipramine) approved by the State Food and Drug Administration (CFDA) for the treatment of OCD in children and adolescents. The drugs used in this study are commonly used in clinical practice and have a good safety profile. The maximum dosage shall not exceed the maximum dosage prescribed in the instruction manual, or the maximum dosage tolerated by the patients. | Drug | Treatment-As-Usual Waitlist Control Group |
| Family-Based Self-help Book for Adolescents with Obsessive-Compulsive DisorderThe self-help book used in this study was independently developed by members of our research team. Its content is based on Exposure and Response Prevention (ERP). Adolescent patients with OCD will be instructed to read one chapter of the self-help book each week and complete the corresponding exercises. This 12-week intervention will involve self-guided practice conducted by the adolescent and their family members.Throughout the intervention period, adolescents and their caregivers may contact the therapist via WeChat to ask questions and upload records of their completed exercises. The therapist will respond to any questions within 48 hours by sending written messages via WeChat, with each family receiving no more than 30 minutes of such written guidance per week. All therapists will be required to keep a weekly log of the time spent providing guidance to each participating family.If a participating family does not initiate contact, the therapist will not provide proactive guidance. | Behavioural | Family-Based Self-Help Intervention Group |
Primary outcome
Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) Total Score
Time frame: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
The CY-BOCS is a clinician-rated instrument used to assess the severity of obsessive-compulsive symptoms in children and adolescents, which has good reliability and validity.. The total score ranges from 0 to 40, with higher scores indicating greater severity. The primary outcome is the change in CY-BOCS total score from baseline to each follow-up point.
5 secondary outcomes
Change in Children's Depression Inventory (CDI) Total Score
Time frame: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
Change in Obsessive-Compulsive Inventory - Child Version (OCI-CV) Total Score
Time frame: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
Change in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score
Time frame: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
Clinical Global Impression - Improvement (CGI-I)
Time frame: Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
Clinical Global Impression - Severity (CGI-S)
Time frame: Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)
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 30 Jul 2025.
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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.
Qing Fan, Doctor study chair
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional medical treatment (TAU) and Family-Based Self-help Book for Adolescents with Obsessive-Compulsive Disorder in people with Obsessive - Compulsive Disorder, run by Shanghai Mental Health Center at 1 site in China.
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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 30 Jul 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 China. 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?
Contact Yiwen Wu (+86 135 8590 0231, wuyiwenhsd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) Total Score (time frame: Baseline, Week 12 (post-intervention), Week 16 (1-month follow-up), Week 24 (3-month follow-up)). 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 30 Jul 2025.