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Could talking therapy ease HIV-Related depression? small study tests culturally adapted CBT

NCT ID NCT07235852

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested a six-session culturally adapted cognitive behavioral therapy (Ca-CBT) for depression and anxiety in 50 people living with HIV in Pakistan. The therapy was delivered by trained HIV health workers and included culturally relevant stories and materials. The study aimed to see if the approach is feasible and acceptable, not yet whether it works.

What this could mean

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

Active substance
Culturally Adapted Cognitive Behavioral Therapy (Ca-CBT)
What this could lead to
If successful, this could provide a practical, low-cost therapy to ease depression and anxiety in people living with HIV, especially in low-literacy settings.
What could go wrong
This is a small pilot study (50 participants) focused on feasibility, not effectiveness. Results may not apply to other populations, and the therapy may not reduce symptoms significantly.

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

50 people

The number who actually took part.

Started

Sep 2025

Finished

May 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: * Adults aged 18-65 years. * Pakistani nationals and residents. * Confirmed HIV diagnosis (newly diagnosed or on ART within 1 month of diagnosis, or already on lifelong ART, according to UNAIDS HIV diagnostic standards). * Meeting criteria for depression and anxiety: HADS subscale score \>8 on both depression and anxiety, and total HADS score \>15. * HIV patients with comorbid conditions (e.g., Hepatitis, HCV) may be included if HIV is the primary condition. Exclusion Criteria: * Diagnosis of bipolar disorder, psychosis, or other severe mental illness according to ICD-11 or DSM-5-TR. * Evidence of learning disability or severe substance use disorder (except nicotine). * Currently receiving psychotherapy or antidepressant medication within the last 6 months. * Current suicidality (per WHO mhGAP) or suicide attempt within the last 2 years. * HIV-associated neurocognitive disorders (HAND) or severe complications of HIV preventing participation, as judged by treating physician. * Living in the same household as another study participant (to prevent contamination between arms).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Family Care Centre (FCC), Hayatabad Medical Complex

    Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

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