BereavementPhase 2PSICODUELAYANCT06150859
Ayahuasca Assisted Psychotherapy for Grief
A Phase 2 study testing Ayahausca-Assisted psychotherapy, Constructivist Psychotherapy and No treatment in people with Bereavement, run by Beckley Med Foundation at 1 site in Spain.
Trial summary
The aim of this study is to compare the effectiveness of an ayahuasca-assisted constructivist therapy with constructivist therapy and no treatment to decrease the severity of grief. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bereavement
- What is being tested?
- Ayahausca-Assisted psychotherapy, Constructivist Psychotherapy and No treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2021to 15 Jun 2024
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Experienced the loss of a first- degree relative not more than 12 months prior to enrollment as indicated by self-report.
- Scores up to 40 in the Texas Revised Inventory of Grief (TRIG).
Who cannot join
- Pregnant or breastfeeding women.
- Hypertension (systolic blood pressure above 140 mm, diastolic above 90 mm and heart rate above 100 bpm).
- History of psychotic disorder (Axis I-II of the DSM-V).
- Substance use disorder (except nicotine).
- Alcohol consumption greater than 40 g/day.
- Receiving psychological or self-help therapy during the study on a regular basis.
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- Receiving regular pharmacological therapy for complicated grief during the study.
- Regular intake of any type of medication in the month preceding the study.
- Treatment with single doses of symptomatic medication during the study may be accepted (as long as it can be assumed that the ingested drug has been completely eliminated on the days of the ayahuasca administrations).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut de Recerca Holistica de Montserat (Irehom)
Barcelona, 08253
About this study
Official title: Efficacy of Ayahuasca in Concert With Psychotherapy to Decrease the Severity of Grief
The aim of this study is to compare the effectiveness of an ayahuasca-assisted constructivist therapy with constructivist therapy and no treatment to decrease the severity of grief. A secondary purpose is to assess the effectiveness to prevent Persistent Complex Bereavement Disorder and Prolonged Grief Disorder, and to assess potential changes in avoidance, meaning-making and self-clarity. Subjective effects and Acceptance promoting effects of psychedelic drug are assessed after ayahuasca administration. A non-randomized controlled trial is proposed with three arms involving an experimental group (ayahuasca in concert with psychotherapy) and two control groups (psychotherapy and no treatment) with pretest, posttest and 3 months follow-up.
Read the detailed description
Grief is a deep and intense sorrow caused by the loss of someone loved. Although every person could benefit from support, only a substantial minority of bereaved people experience severe, persistent and disabling grief (PCBD), requiring treatment one year after the death of a loved one. However, pharmacotherapy alone has not proven to be effective, and while psychological interventions for prolonged grief disorder may be efficacious, the clinical effectiveness is small (Hedges' g: 0.41-0.45). As far as we know, no bereavement prevention program has proven to be effective, and early interventions are discouraged. Thus, there are no effective resources for supporting the bereaved during the months following the death of a loved one, a need which peaks during the months following the death, when grief is most intense and the bereaved lives are at their highest level of risk.
- Conditions
- Bereavement
- Being tested
- Ayahausca-Assisted psychotherapy, Constructivist Psychotherapy, No treatment
- Keywords
- Bereavement, Ayahuasca, Psychotherapy, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ayahausca-Assisted psychotherapyDrug
Also called Ayahausca-assisted grief therapy
Drug: Two ayahuasca administrations (0.75 mg/kg DMT), after 3rd and 6th therapeutic session. Ayahuasca is a psychoactive mixture of plants which contains DMT as an active principle.
Constructivist Psychotherapy will be delivered over 9 online psychotherapeutic sessions.
Constructivist PsychotherapyBehavioural
Constructivist Psychotherapy will be delivered over 9 online psychotherapeutic sessions
No treatmentOther
No treatment during the control period
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Ayahuasca-assisted constructivist therapy. | Experimental | Constructivist psychotherapy will be delivered over 9 online psychotherapeutic sessions interconnected in 3 modules to process trauma, restore attachment security and reconstruct the self. One preparation session and two integration sessions after two ayahuasca administrations are included to the experimental group. Receives: Drug: Ayahausca-Assisted psychotherapy |
| Constructivist Psychotherapy | Active comparator | Constructivist Psychotherapy will be delivered over 9 online psychotherapeutic sessions interconnected in 3 modules to process trauma, restore attachment security and reconstruct the self.
Once the follow-up period is over (3 months), participants have the option of receiving 2 administrations of ayahuasca if the severity of grief is high. Receives: Behavioral: Constructivist Psychotherapy |
| No treatment | Other | Participants received no treatment during the 9-week Control Period.
Once the follow-up period is over (3 months), participants have the option of receiving 2 administrations of ayahuasca if the severity of grief is high. Receives: Other: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the severity of grief symptoms
Change in grief severity is measured by the present scale of Texas- Revised Grief Inventory (TRIG), a measure of normal grief symptoms. For the TRIG the minimum units are 0 and Maximum units on the total scale are 65. The higher the number on the TRIG, the more severe the symptoms.
Measured: Time Frame: Baseline to End of Intervention, up to 3 months
Secondary outcomes (1)
Prevalence of Persisten Complex Bereavement (PCBD) and prolonged Grief Symptoms (PGD).
Measured using the Traumatic Grief Inventory self-report version (TGI-SR). The TGI-SR is a 18-item self-report measure to assess symptoms of Persistent Complex Bereavement Disorder (PCBD) included in Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 and Prolonged Grief Disorder (PGD). A score of ≥61 optimally classified participants as meeting criteria for PCBD-caseness and a score of ≥59 classified participants as meeting criteria for PGD-caseness.
Measured: Baseline to End of Intervention, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start15 Oct 2021
- Primary completion15 Apr 2024 (estimated)
- Study completion15 Jun 2024 (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 BereavementStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beckley Med Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Débora González, Beckley Med Foundation
- Investigators
- Magi Farré, Study director, Hospital German Trials I Pujol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150859
- Sponsor's protocol ID
- PI-19-118
- Acronym
- PSICODUELAYA
- Status last verified
- Dec 2023
- First submitted
- 21 Nov 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sabucedo P, Andion O, Neimeyer RA, Soto-Angona O, Javkin J, Haro JM, Farre M, Gonzalez D. Ayahuasca-assisted meaning reconstruction therapy for grief: a non-randomized clinical trial protocol. Front Psychiatry. 2025 Jan 7;15:1484736. doi: 10.3389/fpsyt.2024.1484736. eCollection 2024.
PubMed 39839135
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ayahuasca in Concert With Psychotherapy to Decrease the Severity of Grief
- ClinicalTrials.gov ID
- NCT06150859
- Acronym / sponsor ID
- PSICODUELAYA / PI-19-118
- Conditions
- Bereavement
- Keywords
- Bereavement, Ayahuasca, Psychotherapy, Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Beckley Med FoundationUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 29 Nov 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.
The aim of this study is to compare the effectiveness of an ayahuasca-assisted constructivist therapy with constructivist therapy and no treatment to decrease the severity of grief. A secondary purpose is to assess the effectiveness to prevent Persistent Complex Bereavement Disorder and Prolonged Grief Disorder, and to assess potential changes in avoidance, meaning-making and self-clarity. Subjective effects and Acceptance promoting effects of psychedelic drug are assessed after ayahuasca administration. A non-randomized controlled trial is proposed with three arms involving an experimental group (ayahuasca in concert with psychotherapy) and two control groups (psychotherapy and no treatment) with pretest, posttest and 3 months follow-up.
Detailed description
Grief is a deep and intense sorrow caused by the loss of someone loved. Although every person could benefit from support, only a substantial minority of bereaved people experience severe, persistent and disabling grief (PCBD), requiring treatment one year after the death of a loved one. However, pharmacotherapy alone has not proven to be effective, and while psychological interventions for prolonged grief disorder may be efficacious, the clinical effectiveness is small (Hedges' g: 0.41-0.45). As far as we know, no bereavement prevention program has proven to be effective, and early interventions are discouraged. Thus, there are no effective resources for supporting the bereaved during the months following the death of a loved one, a need which peaks during the months following the death, when grief is most intense and the bereaved lives are at their highest level of risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Ayahuasca-assisted constructivist therapy. | Experimental | Drug: Ayahausca-Assisted psychotherapyConstructivist psychotherapy will be delivered over 9 online psychotherapeutic sessions interconnected in 3 modules to process trauma, restore attachment security and reconstruct the self. One preparation session and two integration sessions after two ayahuasca administrations are included to the experimental group. |
| Constructivist Psychotherapy | Active comparator | Behavioral: Constructivist PsychotherapyConstructivist Psychotherapy will be delivered over 9 online psychotherapeutic sessions interconnected in 3 modules to process trauma, restore attachment security and reconstruct the self. Once the follow-up period is over (3 months), participants have the option of receiving 2 administrations of ayahuasca if the severity of grief is high. |
| No treatment | Other | Other: No treatmentParticipants received no treatment during the 9-week Control Period. Once the follow-up period is over (3 months), participants have the option of receiving 2 administrations of ayahuasca if the severity of grief is high. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Experienced the loss of a first- degree relative not more than 12 months prior to enrollment as indicated by self-report.
- Scores up to 40 in the Texas Revised Inventory of Grief (TRIG).
Key exclusion criteria (9 listed)
- Pregnant or breastfeeding women.
- Hypertension (systolic blood pressure above 140 mm, diastolic above 90 mm and heart rate above 100 bpm).
- History of psychotic disorder (Axis I-II of the DSM-V).
- Substance use disorder (except nicotine).
- Alcohol consumption greater than 40 g/day.
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 |
|---|---|---|
| Ayahausca-Assisted psychotherapyAlso: Ayahausca-assisted grief therapyDrug: Two ayahuasca administrations (0.75 mg/kg DMT), after 3rd and 6th therapeutic session. Ayahuasca is a psychoactive mixture of plants which contains DMT as an active principle. Constructivist Psychotherapy will be delivered over 9 online psychotherapeutic sessions. | Drug | Experimental: Ayahuasca-assisted constructivist therapy. |
| Constructivist PsychotherapyConstructivist Psychotherapy will be delivered over 9 online psychotherapeutic sessions | Behavioural | Constructivist Psychotherapy |
| No treatmentNo treatment during the control period | Other | No treatment |
Primary outcome
Change in the severity of grief symptoms
Time frame: Time Frame: Baseline to End of Intervention, up to 3 months
Change in grief severity is measured by the present scale of Texas- Revised Grief Inventory (TRIG), a measure of normal grief symptoms. For the TRIG the minimum units are 0 and Maximum units on the total scale are 65. The higher the number on the TRIG, the more severe the symptoms.
1 secondary outcome
Prevalence of Persisten Complex Bereavement (PCBD) and prolonged Grief Symptoms (PGD).
Time frame: Baseline to End of Intervention, up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Derived from this study: PubMed 39839135Sabucedo P, Andion O, Neimeyer RA, Soto-Angona O, Javkin J, Haro JM, Farre M, Gonzalez D. Ayahuasca-assisted meaning reconstruction therapy for grief: a non-randomized clinical trial protocol. Front Psychiatry. 2025 Jan 7;15:1484736. doi: 10.3389/fpsyt.2024.1484736. eCollection 2024.
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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. This study is not recruiting at the moment.
Magi Farré study director
Hospital German Trials I Pujol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ayahausca-Assisted psychotherapy, Constructivist Psychotherapy and No treatment in people with Bereavement, run by Beckley Med Foundation 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 11 Dec 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change in the severity of grief symptoms (time frame: Time Frame: Baseline to End of Intervention, up to 3 months). 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 NCT06150859, 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 11 Dec 2023.