suspensión Completa Del Tratamiento Con BenzodicepinasBENZOS-APNCT06950567
Evaluation of the Effectiveness of a Psychoeducational Intervention on Benzodiazepine Use in the Population Over 64 Years Old in Primary Care
A study testing psycho-educational intervention and therapeutic activity in people with suspensión Completa Del Tratamiento Con Benzodicepinas and Disminución Del Consumo Benzodiacepinas, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
The goal of this pragmatic, multicenter, randomized controlled trial is to determine whether a multidisciplinary psychoeducational intervention combined with therapeutic exercise is more effective than a minimal educational intervention alone in helping older adults with long-term benzodiazepine use discontinue or… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- suspensión Completa Del Tratamiento Con Benzodicepinas, Disminución Del Consumo Benzodiacepinas
- What is being tested?
- psycho-educational intervention and therapeutic activity
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2024to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥65 years.
- Current benzodiazepine use for ≥3 months.
- Ability to provide written informed consent.
Who cannot join
- Severe psychiatric disorder, dementia, or epilepsy.
- Enrollment in a home care program, institutionalization, or palliative care.
- Language barriers or mobility limitations preventing attendance at the primary care centre.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this pragmatic, multicenter, randomized controlled trial is to determine whether a multidisciplinary psychoeducational intervention combined with therapeutic exercise is more effective than a minimal educational intervention alone in helping older adults with long-term benzodiazepine use discontinue or reduce their medication.
The main questions it aims to answer are:
Read more
Does the multidisciplinary intervention increase the proportion of participants who completely discontinue benzodiazepine treatment? Does the intervention reduce the weekly benzodiazepine dose compared with the minimal intervention alone?
Researchers compared a minimal educational intervention ("Benzocarta") with the same intervention plus an 8-week multidisciplinary psychoeducational program and supervised therapeutic exercise.
Participants:
received a personalized educational letter from their family physician explaining the risks of long-term benzodiazepine use and providing guidance for gradual dose reduction; were randomly assigned either to the control group (minimal intervention only) or to the intervention group (minimal intervention plus psychoeducational sessions and therapeutic exercise); were followed for 6 and 18 months after the initial intervention to assess benzodiazepine discontinuation and changes in weekly dose.
Read the detailed description
Long-term benzodiazepine use is common among older adults despite recommendations limiting treatment duration because of the increased risk of dependence, falls, cognitive impairment and other adverse effects. Although several interventions have been proposed to support benzodiazepine deprescribing, their implementation in routine primary care remains limited.
This pragmatic, multicenter randomized controlled trial was designed to evaluate the effectiveness of a multidisciplinary intervention delivered in routine primary care. The intervention combined a minimal educational strategy consisting of a personalized letter from the participant's family physician ("Benzocarta") with an 8-week group-based psychoeducational program and supervised therapeutic exercise. The comparator group received the minimal educational intervention alone, reflecting usual clinical practice.
The intervention was delivered by a multidisciplinary primary care team and focused on promoting benzodiazepine deprescribing through education, behavioural strategies and non-pharmacological management of insomnia, anxiety and stress.
The study was conducted under real-world conditions in four primary care centres. Although the minimum required sample size was 69 participants, recruitment continued during the planned recruitment period because additional family physicians agreed to participate during the planned recruitment period. Consequently, the final enrolled sample exceeded the minimum target specified in the original protocol (122 participants).
Follow-up assessments were performed at 6 and 18 months after the initial intervention to evaluate the long-term sustainability of benzodiazepine deprescribing and the occurrence of late relapse in benzodiazepine use.
Protocol amendment: An additional follow-up assessment at 18 months after the initial intervention was incorporated before data analysis to evaluate the persistence of benzodiazepine discontinuation and potential late relapse. This amendment did not modify participant allocation, study interventions, or outcome definitions.
- Conditions
- suspensión Completa Del Tratamiento Con Benzodicepinas, Disminución Del Consumo Benzodiacepinas
- Being tested
- psycho-educational intervention and therapeutic activity, Control
- Keywords
- Deprescribing, Benzodiazepines, Primary Health Care, Patient Education, Benzodiazepine Withdrawal, Long-term Benzodiazepine Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psycho-educational intervention and therapeutic activityOther
The objective is to provide knowledge and skills to tolerate/reduce discomfort so that they can begin to reduce or discontinue medication (BZD).
The focus is on the effect of combined care, but the implementation of this approach is also evaluated, which will provide valuable knowledge for further health developments in Primary Care.
ControlOther
Sending a "Benzocarta" to each person's postal address-a personalized letter signed by their Family Doctor, an explanatory sheet on how to gradually reduce medication, and infographics on sleep hygiene, stress, or anxiety.
| Study group | Role | What they receive |
|---|---|---|
| control | Sham comparator | Mailing a letter by postal mail Receives: Other: Control |
| Experimental | Active comparator | Mailing a letter by postal mail along with psycho-educational intervention and therapeutic activity. Receives: Other: psycho-educational intervention and therapeutic activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who completely discontinued benzodiazepine treatment
Complete discontinuation of prescribed benzodiazepine treatment, defined as the absence of benzodiazepine use at follow-up, regardless of the baseline dose. The outcome was assessed by comparing the proportion of participants who had completely discontinued treatment in the intervention and control groups.
Measured: 6 and 18 months after the initial intervention
Secondary outcomes (1)
Change in weekly benzodiazepine dose expressed as diazepam equivalents
Change from baseline in the prescribed weekly benzodiazepine dose, expressed as diazepam-equivalent milligrams per week, comparing the intervention and control groups. Among participants who did not completely discontinue treatment, the proportions achieving partial dose reduction or maintaining the same dose were also described.
Measured: 6 and 18 months after the initial intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Apr 2024
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for suspensión Completa Del Tratamiento Con BenzodicepinasStudies 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
- This was a pragmatic, multicenter, parallel-group randomized controlled trial conducted in primary care. Eligible participants identified by family physicians were individually randomized in a 1:2 ratio (intervention:control). All participants received a minimal educational intervention ("Benzocarta"), consisting of a personalized letter signed by their family physician with information on the risks of long-term benzodiazepine use, gradual dose reduction, a tapering schedule, and advice on sleep hygiene and stress management. Participants in the intervention group additionally received an 8-week multidisciplinary psychoeducational program with supervised therapeutic exercise, whereas the control group received no further structured intervention. Outcomes were assessed at 6 and 18 months after the initial intervention.
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacio d'Atencio Primaria
- Responsible party
- Principal investigator, Magi Claveria, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950567
- Sponsor's protocol ID
- 4R24/159
- Acronym
- BENZOS-AP
- Status last verified
- Jul 2026
- First submitted
- 11 Apr 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because the informed consent obtained from participants did not include consent for data sharing. The study involved a relatively small sample recruited from a limited number of primary care practices, which could increase the risk of participant re-identification despite data anonymization. Aggregate study results are reported in the study publication.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Psychoeducational Intervention on Benzodiazepine Use in the Population Over 64 Years Old in Primary Care
- ClinicalTrials.gov ID
- NCT06950567
- Acronym / sponsor ID
- BENZOS-AP / 4R24/159
- Conditions
- suspensión Completa Del Tratamiento Con Benzodicepinas, Disminución Del Consumo Benzodiacepinas
- Keywords
- Deprescribing, Benzodiazepines, Primary Health Care, Patient Education, Benzodiazepine Withdrawal, Long-term Benzodiazepine Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Fundacio d'Atencio Primaria
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 30 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 pragmatic, multicenter, randomized controlled trial is to determine whether a multidisciplinary psychoeducational intervention combined with therapeutic exercise is more effective than a minimal educational intervention alone in helping older adults with long-term benzodiazepine use discontinue or reduce their medication.
The main questions it aims to answer are:
Does the multidisciplinary intervention increase the proportion of participants who completely discontinue benzodiazepine treatment? Does the intervention reduce the weekly benzodiazepine dose compared with the minimal intervention alone?
Researchers compared a minimal educational intervention ("Benzocarta") with the same intervention plus an 8-week multidisciplinary psychoeducational program and supervised therapeutic exercise.
Participants:
received a personalized educational letter from their family physician explaining the risks of long-term benzodiazepine use and providing guidance for gradual dose reduction; were randomly assigned either to the control group (minimal intervention only) or to the intervention group (minimal intervention plus psychoeducational sessions and therapeutic exercise); were followed for 6 and 18 months after the initial intervention to assess benzodiazepine discontinuation and changes in weekly dose.
Detailed description
Long-term benzodiazepine use is common among older adults despite recommendations limiting treatment duration because of the increased risk of dependence, falls, cognitive impairment and other adverse effects. Although several interventions have been proposed to support benzodiazepine deprescribing, their implementation in routine primary care remains limited.
This pragmatic, multicenter randomized controlled trial was designed to evaluate the effectiveness of a multidisciplinary intervention delivered in routine primary care. The intervention combined a minimal educational strategy consisting of a personalized letter from the participant's family physician ("Benzocarta") with an 8-week group-based psychoeducational program and supervised therapeutic exercise. The comparator group received the minimal educational intervention alone, reflecting usual clinical practice.
The intervention was delivered by a multidisciplinary primary care team and focused on promoting benzodiazepine deprescribing through education, behavioural strategies and non-pharmacological management of insomnia, anxiety and stress.
The study was conducted under real-world conditions in four primary care centres. Although the minimum required sample size was 69 participants, recruitment continued during the planned recruitment period because additional family physicians agreed to participate during the planned recruitment period. Consequently, the final enrolled sample exceeded the minimum target specified in the original protocol (122 participants).
Follow-up assessments were performed at 6 and 18 months after the initial intervention to evaluate the long-term sustainability of benzodiazepine deprescribing and the occurrence of late relapse in benzodiazepine use.
Protocol amendment: An additional follow-up assessment at 18 months after the initial intervention was incorporated before data analysis to evaluate the persistence of benzodiazepine discontinuation and potential late relapse. This amendment did not modify participant allocation, study interventions, or outcome definitions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a pragmatic, multicenter, parallel-group randomized controlled trial conducted in primary care. Eligible participants identified by family physicians were individually randomized in a 1:2 ratio (intervention:control). All participants received a minimal educational intervention ("Benzocarta"), consisting of a personalized letter signed by their family physician with information on the risks of long-term benzodiazepine use, gradual dose reduction, a tapering schedule, and advice on sleep hygiene and stress management. Participants in the intervention group additionally received an 8-week multidisciplinary psychoeducational program with supervised therapeutic exercise, whereas the control group received no further structured intervention. Outcomes were assessed at 6 and 18 months after the initial intervention.
| Arm | Type | Receives |
|---|---|---|
| control | Sham comparator | Other: ControlMailing a letter by postal mail |
| Experimental | Active comparator | Other: psycho-educational intervention and therapeutic activityMailing a letter by postal mail along with psycho-educational intervention and therapeutic activity. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥65 years.
- Current benzodiazepine use for ≥3 months.
- Ability to provide written informed consent.
Key exclusion criteria (3 listed)
- Severe psychiatric disorder, dementia, or epilepsy.
- Enrollment in a home care program, institutionalization, or palliative care.
- Language barriers or mobility limitations preventing attendance at the primary care centre.
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 |
|---|---|---|
| psycho-educational intervention and therapeutic activityThe objective is to provide knowledge and skills to tolerate/reduce discomfort so that they can begin to reduce or discontinue medication (BZD). The focus is on the effect of combined care, but the implementation of this approach is also evaluated, which will provide valuable knowledge for further health developments in Primary Care. | Other | Experimental |
| ControlSending a "Benzocarta" to each person's postal address-a personalized letter signed by their Family Doctor, an explanatory sheet on how to gradually reduce medication, and infographics on sleep hygiene, stress, or anxiety. | Other | control |
Primary outcome
Number of participants who completely discontinued benzodiazepine treatment
Time frame: 6 and 18 months after the initial intervention
Complete discontinuation of prescribed benzodiazepine treatment, defined as the absence of benzodiazepine use at follow-up, regardless of the baseline dose. The outcome was assessed by comparing the proportion of participants who had completely discontinued treatment in the intervention and control groups.
1 secondary outcome
Change in weekly benzodiazepine dose expressed as diazepam equivalents
Time frame: 6 and 18 months after the initial intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because the informed consent obtained from participants did not include consent for data sharing. The study involved a relatively small sample recruited from a limited number of primary care practices, which could increase the risk of participant re-identification despite data anonymization. Aggregate study results are reported in the study publication.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psycho-educational intervention and therapeutic activity in people with suspensión Completa Del Tratamiento Con Benzodicepinas and Disminución Del Consumo Benzodiacepinas, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 13 Jul 2026. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who completely discontinued benzodiazepine treatment (time frame: 6 and 18 months after the initial intervention). 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 13 Jul 2026.