Improving Adherence to Homework During Therapy

NCT ID: NCT05866185

Last Updated: 2026-01-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-05-29

Brief Summary

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The purpose of this study is to expand Adhere.ly- a simple, HIPAA-compliant, web-based platform to help therapists engage clients in practicing therapeutic skills between sessions (homework) during mental health treatment by conducting a trial comparing standard therapy to therapy enhanced with Adhere.ly.

Detailed Description

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Conditions

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Anxiety Depression Depression/Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Therapy

Standard regular therapy.

Group Type ACTIVE_COMPARATOR

Therapy

Intervention Type BEHAVIORAL

The standard of care procedures for adults with clinically elevated anxiety and/or depression from their mental health provider.

Therapy + Adhere.ly

Standard regular therapy, enhanced with Adhere.ly

Group Type EXPERIMENTAL

Therapy + Adhere.ly

Intervention Type BEHAVIORAL

Participants receive therapy as usual enhanced with a simple, HIPAA-compliant, web-based application to help mental health providers implement homework during therapy for adults with elevated anxiety and/or depression. The three major components of the app help providers to (1) Practice interactive, digitized therapeutic exercises with patients in-session; (2) Remind patients to practice exercises for homework, and (3) Review homework during the next session.

Interventions

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Therapy

The standard of care procedures for adults with clinically elevated anxiety and/or depression from their mental health provider.

Intervention Type BEHAVIORAL

Therapy + Adhere.ly

Participants receive therapy as usual enhanced with a simple, HIPAA-compliant, web-based application to help mental health providers implement homework during therapy for adults with elevated anxiety and/or depression. The three major components of the app help providers to (1) Practice interactive, digitized therapeutic exercises with patients in-session; (2) Remind patients to practice exercises for homework, and (3) Review homework during the next session.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Providers:

* English-speaking
* Mental health providers who have obtained at least a master's degree in social work, counseling, clinical psychology, or related field
* Carry active mental health treatment caseloads in the U.S.
* Have a laptop, tablet, or smartphone with internet access

Clients:

* English-speaking
* Treatment-seeking adults ≥18 years
* Clinically elevated anxiety and depression as indicated by a score ≥10 on the GAD-7 and/or PHQ-8
* Have a laptop, tablet, or smartphone with internet access

Exclusion Criteria

Client with self-reported:

* Active psychotic symptoms (e.g., hallucinations, delusions)
* Significant cognitive disability.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian E Bunnell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

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University of South Florida

Tampa, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5R41MH126734-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

002555

Identifier Type: -

Identifier Source: org_study_id

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