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Not yet recruiting NCT06910683

Technology dRiven Enhancement to Engage & Connect

No phase Interventional Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TREE-Connect, Clinician-delivered psychotherapy.
Who it may be relevant to
Registry conditions: Depression. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

This study will investigate whether an intervention that includes remotely delivered therapy sessions and a digital mental health app, compared to only remotely delivered therapy reduces late-life depression

Detailed description

Depression in mid- and late-life is characterized with reduced functions of the reward system. The investigators designed a psychotherapy that aims to improve reward functions through engagement in pleasurable activities and in turn reduce depression. Prior work has shown that this therapy is acceptable and reduces depression. This study examines whether a hybrid intervention that combines clinician remotely-delivered psychotherapy, and a novel app named TREE-Connect, reduces late life depression. This TREE-Connect app uses a machine learning algorithm to promote adherence to therapy (completion of therapeutic homework) in late-life depression and increase cost-effectiveness and reach of treatment to older adults. This randomized controlled trials will test whether the hybrid intervention (clinician-delivered psychotherapy + app), compared to a condition that includes solely clinician-delivered therapy is acceptable and reduces late-life depression.

Interventions

  • Behavioral TREE-Connect
    TREE-Connect is a mental health app that aims to increase engagement in rewarding activities
  • Behavioral Clinician-delivered psychotherapy
    Clinician-delivered psychotherapy is delivered remotely and aimed to increase engagement in rewarding activities

Primary outcome measures

  • Acceptability (Client Satisfaction Questionnaire; CSQ) [Time frame: 9 Weeks]

Eligibility criteria

Inclusion criteria

  • Adults aged 50-80
  • Capacity to provide consent for research assessment and treatment.
  • Significant depression, i.e., PHQ-9 ≥ 7 (mild-moderate severity of symptoms)
  • Mini Mental Status Exam (MMSE) equal or greater than a score of 23.
  • Off antidepressants or on stable dose for 8 weeks and do not intend to change the dose in the next 10 weeks, without individual psychotherapy services during the study period.

Exclusion criteria

  • Intent or plan to commit suicide in the near future.
  • Inability to communicate in English.
  • History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, specific phobia, or antisocial or borderline personality disorder.
  • Neurological disorders (dementias, amnestic and multidomain Mild Cognitive Impairment, Parkinson's disease, epilepsy, etc.).
  • Acute or severe medical illness in the past 3 months (metastatic cancer, multiple sclerosis, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction, cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease, etc.) that may be the primary cause depressive symptoms, influence brain systems of interest, or impact ability to participate in the study.
  • For MRI only: Contraindications to MRI scanning including cardiac pacemaker, heart valve replacement, vascular stent, insulin pump, cochlear implant, any other metallic biomedical implant contraindicating to MRI, and claustrophobia.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Weill Cornell Medicine — New York

Identifiers

NCT: NCT06910683 · 24-04027370

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗