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Behavioural Intervention

Intervention group for Depression (FTP Trial)

N/A
Waitlist Available
Led By Paola Pedrelli, PhD
Research Sponsored by Hedonia Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4, and week 8
Awards & highlights

FTP Trial Summary

This trial compares how well a mobile app using FTP can reduce depressive symptoms vs. not using the app.

Eligible Conditions
  • Depression

FTP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4, and week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4, and week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Anhedonia level on the Snaith-Hamilton Pleasure Scale (SHAPS)
Change in breadth of thought and ruminations scores on the Ruminative Response Scale (RRS)
Change in depression scores on the Montgomery-Åsberg Depression Rating Scale (MADRS clinical assessment)
Secondary outcome measures
Change in anxiety measure on the General Anxiety Disorder-7 (GAD-7)
Change in depression symptoms severity on the Patient Health Questionnaire (PHQ-9)
Change in depression symptoms severity on the Symptoms of Depression Questionnaire (SDQ)
+4 more

FTP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 Intervention
Individuals with Major Depressive Disorder who have access to an FTP-based mobile phone application for eight weeks.
Group II: Control groupActive Control1 Intervention
Individuals with Major Depressive Disorder who are on an 8-week waitlist (delayed intervention) before being offered to use the app. During the eight weeks, they will be subjected to the same questionnaires and assessments as the intervention arm.

Find a Location

Who is running the clinical trial?

Hedonia LtdLead Sponsor
Paola Pedrelli, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
96 Total Patients Enrolled
1 Trials studying Depression
96 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can I become an active participant in this trial?

"Qualifying for this study entails having a diagnosis of depression and being birthed between two decades. We are seeking 110 participants in total to take part in the clinical trial."

Answered by AI

Does the research study include participants aged 45 or older?

"Based on the stated eligibility requirements, only individuals aged 20 to 50 are able to register for this medical trial. In contrast, there are 393 trials targeting minors and 1428 studies concentrating on seniors."

Answered by AI

How many participants are currently enlisted in this clinical trial?

"Affirmative. According to clinicaltrials.gov, the trial is currently enrolling participants; it was originally posted on November 3rd 2022 and recently modified on January 5th 2023. The investigation requires 110 applicants from one medical centre."

Answered by AI

Is enrollment still open for the trial participants?

"Affirmative. The information provided by clinicaltrials.gov suggests that the research, which was first unveiled on November 3rd 2022, is actively searching for participants to join in this experiment. A total of 110 individuals from a single medical site need to be recruited for this study."

Answered by AI

What results are researchers hoping to achieve with this medical experiment?

"As per the information provided by the study sponsor, Hedonia Ltd., this research will measure Change in breadth of thought and ruminations scores on the Ruminative Response Scale (RRS) over a Baseline, week 4, and week 8 time-frame. Moreover, secondary objectives include assessing changes in depression symptoms severity with Symptoms of Depression Questionnaire (SDQ), General Anxiety Disorder-7's (GAD-7) evaluation of anxiety levels, as well as World Health Organization Quality of Life scale - short version's(WHO-QOL BREF's) assessment of quality life score."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Treatment for Depression Via a Gamified Mobile Phone Application Based on a New Cognitive Model
Paola Pedrelli 2022. "A Treatment for Depression Via a Gamified Mobile Phone Application Based on a New Cognitive Model". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05685758.
~48 spots leftby Apr 2025
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