Health TrialsbyHealthPanel

IMPACT (IMproving Proactive Approaches for Cancer Survivors' Mental Health Treatment)

ConditionsDepressionDepressive SymptomsCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina

About this trial

The purpose of this research study is to evaluate a mobile application (app) for depression treatment called "Moodivate" among cancer survivors. Moodivate was developed by our research team to assist with the treatment of depressed mood.

Participants will be randomly assigned to either download the mobile app, "Moodivate", or not. Approximately 2/3 of participants enrolled will receive the mobile app and the remaining 1/3 will not.

All participants will complete electronic questionnaire measures throughout the study period. Questionnaires will assess symptoms of depression, as well as your experiences using Moodivate and participating in this trial. Participation in this study will take about 12 weeks, beginning today.

Participation in this study may help in the treatment of future cancer survivors. The greatest risks of this study include frustration, worsening of emotional distress, data breach, and/or loss of confidentiality. Alternative treatments include contacting your primary care provider or your oncology care team to discuss other available treatments for depressed mood.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

ILLIC (as determined during manual chart review)

Elevated depressive symptoms, defined as a score of ≥ 8 on the PHQ-9

Current owner of an iOS- or Android-compatible smartphone

Disqualifiers

Current suicidal ideation at study screening, defined as a response greater than or equal to 1 on item nine of the PHQ-9

Prior diagnosis of dementia, or Major Neurocognitive Disorder indicated either via self-report or in the EHR; or

Self-report of cognitive difficulties that impair functional independence

Trial design

Design model

Parallel

Treatments tested in this trial

  • Behavioral Activation Therapy App

    Behavioral

    Moodivate focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.

  • Treatment as Usual

    Behavioral

    Participants will be provided educational material about mood management available via the EHR with the suggestion to discuss questions with their oncology provider. Participants will be asked to complete questionnaire measures weekly for 8 weeks with a final follow up at week 12.

Treatment groups

279 Participants
are divided into 2 treatment groups
Group A: Treatment as UsualOther 1 intervention
Group B: MoodivateExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Depression

Change in the Patient Health Questionnaire (PHQ-9) score from baseline. The PHQ-9 scoring is 1-27 where 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, 15-19 is moderately severe depression, and 20-27 is severe depression.

Time frame
12 weeks

Secondary outcomes

1

Change in Anxiety Symptoms

Change in the Hospital Anxiety and Depression Scale, Anxiety subscale (HADS-A) score from baseline. Scoring is on a scale from 0-21 where 0-7 = Normal, 8-10 = Borderline abnormal (borderline case), and 11-21 = Abnormal (case).

Time frame
12 weeks
2

Change in Quality of Life

Change in the Functional Assessment of Cancer Therapy-General (FACT-G7) score from baseline. The scoring is 0-28 using a 5 point likert scale where the a higher score indicates a better the quality of life.

Time frame
12 weeks
3

Clinical Response Rate

The proportion of patients with a clinically meaningful improvement in depressive symptoms (decrease of ≥5 points on the Patient Health Questionnaire assessment) from baseline to each time point

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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