Mindfulness-based Intervention for Depressive Symptoms Sent Via Text (MINDSET)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCase Comprehensive Cancer Center

About this trial

The purpose of this study is to develop and test a new intervention to reduce depressive symptoms in post-treatment cancer participants.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Self-reported mild to moderately-severe symptoms of depression (score 5-19 on PHQ-9).

A diagnosis of stage 0-III breast, prostate, or colorectal cancer.

Completion of primary cancer treatment within 2 years (excludes hormone therapy).

An ability to provide informed consent.

Disqualifiers

Self-reported minimal and severe depressive symptoms (<4 and > 20 on PHQ-9).

Self-reported suicidal ideation (>1 on item 9 PHQ-9).

Another psychological, medical, or other condition/issue determined that necessitates priority treatment and/or that would interfere with participation (e.g., schizophrenia, borderline personality disorder)

Current or recent substance abuse/dependence.

Trial design

Design model

Parallel

Treatments tested in this trial

  • MINDSET

    Behavioral

    Participants randomized to MINDSET will receive a text message at their preferred time each day for 8 weeks containing a link to the 15-minute audio content. At the end of each week (on day 7), participants will receive a second link to the weekly survey in the text. Participants will be able to play the audio content on their device by clicking the first link and access the weekly survey by clicking the second.

  • Enhanced Usual Care (EUC)

    Behavioral

    Participants will receive a 1-page brochure summarizing publicly available information on depression self-care strategies via text each week for 8 weeks on the same day they receive the text message containing a link to the weekly survey (day 7). This information will come from the Facing Forward: Life After Cancer Treatment booklet from the National Cancer Institute.38 Weekly topics will include: 1) Reducing stress; 2) Coping with stress; 3) Coping with depression; 4) Feeling angry; 5) Feeling alone; 6) Finding meaning after treatment; 7) Social relationships; and 8) Seeking support. These materials do not include any content on mindfulness or cognitive therapy.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: ARM 1Experimental treatment 1 intervention
Group B: ARM 2Other 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility as assessed by listening rate

80% listening rate of daily audio content

Time frame
12 weeks
2

Feasibility as assessed by sample retention rate

80% sample retention

Time frame
12 weeks
3

Acceptability rate as assessed by satisfaction rating of daily audio content

(\>8 median satisfaction rating of daily audio content is measured as accepatble

Time frame
12 weeks
4

Acceptability rate as assessed by Client Satisfaction Questionnaire (CSQ-8) post-MINDSET

\>24 on the Client Satisfaction Questionnaire (CSQ-8) post-MINDSET will be considered as acceptable. CSQ-8 is a list of questions rating the satisfaction ranging from quite dissatisfied to very satisfied

Time frame
12 weeks

Secondary outcomes

1

Symptoms of depression as measured by PROMIS-D-SF

The PROMIS-D-SF is an 8-question survey that measures depression on a scale from 1 (never) to 5 (always).

Time frame
12 weeks
2

Symptoms of anxiety as measured by PROMIS-A-SF

The PROMIS-A-SF is an 8-question survey that measures anxiety on a scale from 1 (never) to 5 (always).

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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