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Could a talking therapy ease the weight of bipolar depression?

NCT ID NCT06365021

Symptom relief Sponsor: Beny Lafer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This trial tests whether Acceptance and Commitment Therapy (ACT), a type of talking therapy that focuses on psychological flexibility, can reduce depressive symptoms in people with bipolar disorder. Participants will attend 12 weekly group sessions of ACT alongside their usual medication, while a comparison group receives a shorter psychoeducation program. The study tracks mood, quality of life, daily functioning, and sleep over a year to see if ACT offers meaningful benefits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Acceptance and Commitment Therapy (ACT), a 12-session group psychotherapy protocol
What this could lead to
If effective, ACT could offer a new psychological tool to help people with bipolar disorder manage depressive symptoms and improve daily functioning and quality of life.
What could go wrong
This is a relatively small trial, and the benefits of ACT for bipolar depression are not yet established. Results may not generalize, and therapy requires commitment to weekly sessions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

75 people

The number who actually took part.

Started

May 2024

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of Bipolar Disorder type I and II according to DSM V * Presence of depressive symptoms (MADRS\>12) * Not undergoing psychotherapy * Availability to attend in-person group therapy sessions * Signing consent form Exclusion Criteria: * Organic mental disorder * Presence of manic or hypomanic symptoms (YMRS\>12) * Currently undergoing psychotherapy (not able to pause during the study) * Major medication change in last 30 days

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Conditions

The condition(s) this trial relates to.

bipolar disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar disorder

Contacts and locations

Locations

  • Tatiana Cohab Khafif

    São Paulo, São Paulo, 01231010, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.