Attention Deficit Hyperactivity DisorderNCT06080373
CBT for Adult Inmates With ADHD
A study testing PROBECO and Formulation-based cognitive behavioral therapy in people with Attention Deficit Hyperactivity Disorder, run by Universidad Europea de Valencia.
Trial summary
Background Recent literature suggests that ADHD is a risk factor for the development of antisocial behavior that is more severe and persistent than in community and other psychiatric populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- PROBECO and Formulation-based cognitive behavioral therapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- Sep 2027to Sep 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To have signed written informed consent to participate in the study
- To be between 18 and 65 years of age
- To meet the DSM-5 diagnostic criteria for ADHD (American Psychiatric Association, 2013)
- To have been convicted of at least one crime under Spanish or German criminal law
- To have been incarcerated for at least six months and three or fewer years since the completion of the conviction at the time of eligibility assessment.
Who cannot join
- To have a severe personality disorder, psychotic disorder, or pervasive developmental disorder as their primary diagnosis, as the intervention would not meet their clinical needs
- To have an IQ of 80 or less, as measured by a standardized IQ test (Raven et al., 1993), due to the complexity of the cognitive components in the CBT program
- To have participated in a previous psychological intervention for ADHD;
- To not be fluent in Spanish or German, depending on the study site.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Formulation-Based Cognitive-Behavioral Therapy Compared to an Active Control and a Waitlist in Adult Inmates With ADHD: A Randomized Controlled Trial
Background Recent literature suggests that ADHD is a risk factor for the development of antisocial behavior that is more severe and persistent than in community and other psychiatric populations. The combination of stimulant medication and psychotherapy (particularly cognitive-behavioral therapy, CBT) is considered an evidence-based intervention for adults with ADHD. In contrast, few studies have evaluated the efficacy of medication in adult prisoners with ADHD, and the literature on the efficacy of psychotherapy is virtually nonexistent. Therefore, this article presents the protocol of a trial that will assess the efficacy of a formulation-based CBT program for inmates with ADHD.
Methods The study has a multicenter randomized controlled trial design. After screening and recruitment, participants will be randomly assigned to the CBT intervention, a general offender treatment program, or a waitlist. Pre- and post-treatment self-report and clinician-report assessments, as well as 6- and 12-month follow-up assessments will be conducted. These will include both clinical (e.g., ADHD symptoms, depression and anxiety symptoms, self-esteem, alcohol/drug abuse, treatment adherence, quality of life) and criminological (e.g., recidivism and risk of recidivism) measures. Linear mixed models will be used to assess differences between groups.
Discussion This study may be the first to evaluate the efficacy of a psychotherapy intervention in adult inmates with ADHD. It is expected that addressing the specific needs of ADHD would not only result in the previously reported clinical improvements (e.g., reduction in ADHD and comorbidity symptoms), but also reduce the risk and rate of recidivism compared to the general intervention or no intervention. However, the design may be limited by the difficulties inherent in the prison setting and in following up the sample after release.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- PROBECO, Formulation-based cognitive behavioral therapy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROBECOBehavioural
Spanish participants in the active control group will undergo the PROBECO program, designed by the Spanish Penitentiary Agency for various violent crimes. It aims to eradicate criminal behavior, reduce recidivism, and teach social skills. It has four phases.
German participants will be placed in social therapeutic facilities for compulsory psychotherapy focused on relapse prevention.
Formulation-based cognitive behavioral therapyBehavioural
The CBT program includes these core modules:
- ADHD Psychoeducation: Provides information on ADHD characteristics, neurobiology, treatments, and their efficacy. Shared with a significant other if available.
- Planning Skills and Distraction Management: Teaches time management, task prioritization, and distraction control techniques.
- Cognitive Restructuring: Based on Ellis' Rational Behavioral Emotive Therapy, it helps participants identify and modify irrational thoughts for better emotional regulation.
- Maintenance of Treatment Gains: Reviews progress, identifies risk factors, and develops action plans for post-treatment challenges.
| Study group | Role | What they receive |
|---|---|---|
| Formulated-based cognitive behavioral therapy | Experimental | Participants randomized to the CBT group will receive a minimum of 13 and a maximum of 22 sessions of individual formulation-based CBT. It will be delivered by psychologists trained in CBT, according to a manual that will be available soon. Prior to intervention, a behavioral assessment is conducted to operationalize each case's clinically relevant behaviors, antecedents, and maintenance stimuli. Each case will be formulated and presented to the participant in simple and easy to understand language. To illustrate this, a schematic formulation of the typical case of an adult with ADHD is shown in Figure 2. Specific behavioral goals will then be agreed upon for each participant. To achieve these goals, various treatment strategies will be presented in the following sessions. The choice of strategies, the order in which they are applied, and the duration of each module will be customized for each participant according to the case formulation. Receives: Behavioral: Formulation-based cognitive behavioral therapy |
| PROBECO and social therapeutic establishments | Active comparator | The Spanish participants assigned to the active control group will receive the PROBECO. It is a group program designed by the Spanish Penitentiary Agency for its application with inmates convicted of different types of violent crimes . Its main goals are to eradicate criminal behavior and reduce recidivism, to modify the relevant dynamic risk factors related to general delinquency, and to introduce new social skills and prosocial values. It consists of four phases: (I) general intervention: aimed at the acquisition of social skills; (II) specific intervention: consists of four specific educational itineraries; (III) relapse prevention; (IV) follow-up.
Similarly, German participants will be assigned to a special type of prison known as a social therapeutic facility, where they will undergo compulsory psychotherapy focused primarily on relapse prevention. Receives: Behavioral: PROBECO |
| Waitlist | No intervention | Participants in waitlist control group will receive no treatment while experimental groups are treated. They will be offered to receive CBT after the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conners Adult ADHD Diagnostic Interview for DSM-IV (CAADID)
This is considered one of the primary outcomes. The CAADID is a structured interview divided into two parts. Part I may be self-administered or clinician-administered and collects information on the subject's demographic history, developmental history, associated risk factors, and comorbidity, while Part II must be administered by a trained clinician and assesses DSM-IV criteria for ADHD in adults. Only Part II will be used for the study, as information on patient history is not relevant for measuring response to interventions.
Measured: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
Reoffending rate
This will be the primary criminological outcome. Police records will be checked every 6 months after the end of treatment to look for new arrests. We will also try to check court and prison records for new convictions and incarcerations. However, access to this information may be very limited in European criminal justice systems, so it may be difficult to obtain.
Measured: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
Secondary outcomes (7)
Clinical Global Impression (CGI)
Is a three-item observer-rated scale that measures illness severity, global improvement or change, and therapeutic response. It is a widely used, robust measure of efficacy in clinical trials. The global functioning outcome provides a measure of the impact that symptoms have on daily functioning in life domains (e.g., social, family, work, personal, and academic, among others).
Measured: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
Attention-deficit/hyperactivity rating scale-IV
This measure will be the primary self-reported outcome. The scale includes 18 items that reference DSM-IV criteria (American Psychiatric Association, 2000), and it is used to determine the presence and severity of current ADHD symptoms. Each item is scored from 0 (never, rarely) to 3 (often). This measure has high validity and reliability and has been widely used both for clinical and research purposes.
Measured: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
Rosenberg self-esteem scale (RSES
This 10-item scale provides a unidimensional measure of global self-esteem and acceptance of self-worth.
Measured: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
Adult ADHD Quality of Life Questionnaire (AAQoL
It is an ecologically valid measure of the quality of life designed specifically for adults with ADHD. It consists of 29 items corresponding to four domains particularly relevant for patients with ADHD: productivity, psychological health, social relationships, and life perspectives.
Measured: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
Maudsley Addiction Profile (MAP)
This is a 60-item, multidimensional instrument for assessing treatment outcome in people with drug and/or alcohol problems.
Measured: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
Beck depression inventory-II (BDI-II) and Beck anxiety inventory (BAI)
These are one of the most commonly used self-report instruments to assess the severity of depressive and anxiety symptoms, respectively. A total score is obtained from the sumo of its 21 items, with higher scores indicating higher levels of depression or anxiety.
Measured: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
Historical Clinical Risk Management-20 (HCR-20)
This instrument is a guide to predicting violence risk in inmates and psychiatric patients, providing a probabilistic prediction of the risk of future antisocial behavior. A trained rater must assess the presence of 20 past, present, and future risk factors organized into three different scales. The HCR-20 includes both dynamic and static risk factors. Three levels of risk can be identified without initial reference to explicit tables, scales, or cutoff points: low, moderate, or high (and imminent).
Measured: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study startSep 2027 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos López-Pinar, Universidad Europea de Valencia
- Investigators
- Carlos López-Pinar, Dr, Principal investigator, Universidad Europea de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080373
- Sponsor's protocol ID
- UEuropeaValencia
- Status last verified
- Apr 2026
- First submitted
- 6 Oct 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopez-Pinar C, Martinez-Sanchis S, Carbonell-Vaya E, Martinez-Raga J, Retz W. Formulation-based cognitive behavioral therapy compared to an active control and a waitlist in adult inmates with ADHD: study protocol for a randomized controlled trial. Trials. 2024 Sep 6;25(1):594. doi: 10.1186/s13063-024-08434-w.
PubMed 39243058
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formulation-Based Cognitive-Behavioral Therapy Compared to an Active Control and a Waitlist in Adult Inmates With ADHD: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06080373
- Acronym / sponsor ID
- UEuropeaValencia
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Universidad Europea de ValenciaUniversity, hospital or other
- Study start
- Sep 2027 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 12 Oct 2023 (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.
Background Recent literature suggests that ADHD is a risk factor for the development of antisocial behavior that is more severe and persistent than in community and other psychiatric populations. The combination of stimulant medication and psychotherapy (particularly cognitive-behavioral therapy, CBT) is considered an evidence-based intervention for adults with ADHD. In contrast, few studies have evaluated the efficacy of medication in adult prisoners with ADHD, and the literature on the efficacy of psychotherapy is virtually nonexistent. Therefore, this article presents the protocol of a trial that will assess the efficacy of a formulation-based CBT program for inmates with ADHD.
Methods The study has a multicenter randomized controlled trial design. After screening and recruitment, participants will be randomly assigned to the CBT intervention, a general offender treatment program, or a waitlist. Pre- and post-treatment self-report and clinician-report assessments, as well as 6- and 12-month follow-up assessments will be conducted. These will include both clinical (e.g., ADHD symptoms, depression and anxiety symptoms, self-esteem, alcohol/drug abuse, treatment adherence, quality of life) and criminological (e.g., recidivism and risk of recidivism) measures. Linear mixed models will be used to assess differences between groups.
Discussion This study may be the first to evaluate the efficacy of a psychotherapy intervention in adult inmates with ADHD. It is expected that addressing the specific needs of ADHD would not only result in the previously reported clinical improvements (e.g., reduction in ADHD and comorbidity symptoms), but also reduce the risk and rate of recidivism compared to the general intervention or no intervention. However, the design may be limited by the difficulties inherent in the prison setting and in following up the sample after release.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Formulated-based cognitive behavioral therapy | Experimental | Behavioral: Formulation-based cognitive behavioral therapyParticipants randomized to the CBT group will receive a minimum of 13 and a maximum of 22 sessions of individual formulation-based CBT. It will be delivered by psychologists trained in CBT, according to a manual that will be available soon. Prior to intervention, a behavioral assessment is conducted to operationalize each case's clinically relevant behaviors, antecedents, and maintenance stimuli. Each case will be formulated and presented to the participant in simple and easy to understand language. To illustrate this, a schematic formulation of the typical case of an adult with ADHD is shown in Figure 2. Specific behavioral goals will then be agreed upon for each participant. To achieve these goals, various treatment strategies will be presented in the following sessions. The choice of strategies, the order in which they are applied, and the duration of each module will be customized for each participant according to the case formulation. |
| PROBECO and social therapeutic establishments | Active comparator | Behavioral: PROBECOThe Spanish participants assigned to the active control group will receive the PROBECO. It is a group program designed by the Spanish Penitentiary Agency for its application with inmates convicted of different types of violent crimes . Its main goals are to eradicate criminal behavior and reduce recidivism, to modify the relevant dynamic risk factors related to general delinquency, and to introduce new social skills and prosocial values. It consists of four phases: (I) general intervention: aimed at the acquisition of social skills; (II) specific intervention: consists of four specific educational itineraries; (III) relapse prevention; (IV) follow-up. Similarly, German participants will be assigned to a special type of prison known as a social therapeutic facility, where they will undergo compulsory psychotherapy focused primarily on relapse prevention. |
| Waitlist | No intervention | –Participants in waitlist control group will receive no treatment while experimental groups are treated. They will be offered to receive CBT after the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To have signed written informed consent to participate in the study
- To be between 18 and 65 years of age
- To meet the DSM-5 diagnostic criteria for ADHD (American Psychiatric Association, 2013)
- To have been convicted of at least one crime under Spanish or German criminal law
- To have been incarcerated for at least six months and three or fewer years since the completion of the conviction at the time of eligibility assessment.
Key exclusion criteria (4 listed)
- To have a severe personality disorder, psychotic disorder, or pervasive developmental disorder as their primary diagnosis, as the intervention would not meet their clinical needs
- To have an IQ of 80 or less, as measured by a standardized IQ test (Raven et al., 1993), due to the complexity of the cognitive components in the CBT program
- To have participated in a previous psychological intervention for ADHD;
- To not be fluent in Spanish or German, depending on the study site.
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 |
|---|---|---|
| PROBECOSpanish participants in the active control group will undergo the PROBECO program, designed by the Spanish Penitentiary Agency for various violent crimes. It aims to eradicate criminal behavior, reduce recidivism, and teach social skills. It has four phases. German participants will be placed in social therapeutic facilities for compulsory psychotherapy focused on relapse prevention. | Behavioural | PROBECO and social therapeutic establishments |
| Formulation-based cognitive behavioral therapyThe CBT program includes these core modules: A. ADHD Psychoeducation: Provides information on ADHD characteristics, neurobiology, treatments, and their efficacy. Shared with a significant other if available. B. Planning Skills and Distraction Management: Teaches time management, task prioritization, and distraction control techniques. C. Cognitive Restructuring: Based on Ellis' Rational Behavioral Emotive Therapy, it helps participants identify and modify irrational thoughts for better emotional regulation. D. Maintenance of Treatment Gains: Reviews progress, identifies risk factors, and develops action plans for post-treatment challenges. | Behavioural | Formulated-based cognitive behavioral therapy |
Primary outcome
Conners Adult ADHD Diagnostic Interview for DSM-IV (CAADID)
Time frame: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
This is considered one of the primary outcomes. The CAADID is a structured interview divided into two parts. Part I may be self-administered or clinician-administered and collects information on the subject's demographic history, developmental history, associated risk factors, and comorbidity, while Part II must be administered by a trained clinician and assesses DSM-IV criteria for ADHD in adults. Only Part II will be used for the study, as information on patient history is not relevant for measuring response to interventions.
Reoffending rate
Time frame: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
This will be the primary criminological outcome. Police records will be checked every 6 months after the end of treatment to look for new arrests. We will also try to check court and prison records for new convictions and incarcerations. However, access to this information may be very limited in European criminal justice systems, so it may be difficult to obtain.
7 secondary outcomes
Clinical Global Impression (CGI)
Time frame: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
Attention-deficit/hyperactivity rating scale-IV
Time frame: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
Rosenberg self-esteem scale (RSES
Time frame: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
Adult ADHD Quality of Life Questionnaire (AAQoL
Time frame: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
Maudsley Addiction Profile (MAP)
Time frame: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
Beck depression inventory-II (BDI-II) and Beck anxiety inventory (BAI)
Time frame: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
Historical Clinical Risk Management-20 (HCR-20)
Time frame: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
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 6 May 2026.
- Derived from this study: PubMed 39243058Lopez-Pinar C, Martinez-Sanchis S, Carbonell-Vaya E, Martinez-Raga J, Retz W. Formulation-based cognitive behavioral therapy compared to an active control and a waitlist in adult inmates with ADHD: study protocol for a randomized controlled trial. Trials. 2024 Sep 6;25(1):594. doi: 10.1186/s13063-024-08434-w.
- Individual participant dataSharing planned: No
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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.
Carlos López-Pinar, Dr principal investigator
Universidad Europea de Valencia
Questions about this trial
What is this clinical trial studying?
A study testing PROBECO and Formulation-based cognitive behavioral therapy in people with Attention Deficit Hyperactivity Disorder, run by Universidad Europea de Valencia.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Carlos López-Pinar, Dr (+34 665878367, carloslopez.pinar@universidadeuropea.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conners Adult ADHD Diagnostic Interview for DSM-IV (CAADID) (time frame: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention). The study lists 2 primary outcomes in all. 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 NCT06080373, which also lists 1 linked publication.
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 6 May 2026.