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Group PACBT for Depression

ConditionsDepression - Major Depressive DisorderPsilocybinCognitive Behavioral Therapy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-60
SponsorUniversity of California, Los Angeles

About this trial

This study will seek to determine the (1) acceptability and (2) feasibility of psilocybin as an adjunct to cognitive-behavioral therapy, delivered as a group treatment (G-PACBT) for major depressive disorder and (3) explore the clinical effects of G-PACBT on depressive symptoms and psychosocial functioning.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ages 21-60,

Fluent in English

Able to swallow capsules,

Meets for a current major depressive episode or a history of major depressive episodes based on the DSM-5 criteria (American Psychiatric Association, 2013),

Disqualifiers

A personal or family history (first-degree) of psychosis or mania

Resting blood pressure above 140 systolic, 90 diastolic or heart rate > 90 beats per minute (averaged across four separate measurements)

Meeting criteria for a DSM-5 cluster B personality disorder (narcissistic, histrionic, borderline, antisocial personality disorder),

Active suicidality (i.e., HAM-D item 3 score of greater than 3) or other psychiatric disturbance requiring acute treatment

Trial design

Design model

Single group

Treatments tested in this trial

  • Psilocybin (drug)

    Drug

    Two administrations of psilocybin, administered orally (a 10mg dose followed by a 25mg dose one month later)

  • Group Cognitive Behavioral Therapy

    Behavioral

    12 sessions of PA-CBT (as manualized by our research team; Weintraub et al., 2023)

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Group PACBTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Treatment acceptability

Treatment acceptability as measured by the participant on the Client Satisfaction Questionnaire-8. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.

Time frame
4 months (Baseline to Post-treatment)
2

Feasibility as measured by participant retention

Participant retention over the treatment

Time frame
4 months
3

Hamilton Depression Rating Scale

Depressive symptom severity scored from 0-53, with larger values indicating greater depressive severity

Time frame
7 months (Baseline to end of study)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: