Promoting Widowed Elders Lifestyle After Loss
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|ClinicalTrials.gov Identifier: NCT02631291|
Recruitment Status : Recruiting
First Posted : December 16, 2015
Last Update Posted : June 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mood Disorders Depression Anxiety Grief Bereavement Health Behavior||Behavioral: Behavioral self-monitoring Behavioral: Behavioral self-monitoring + Motivational interviewing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Pilot Study of Behavioral Self-monitoring to Promote Mental Health Among Spousally Bereaved Older Adults|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
Behavioral self-monitoring of daily physical activity, dietary, and sleep behaviors, for 12 weeks, into an electronic tablet.
Behavioral: Behavioral self-monitoring
Behavioral self-monitoring will teach older adults to pay attention to their daily lifestyle practices and the conditions in which they occur. Behavioral self-monitoring is crucial for detecting change early, thereby preventing complications (mental illness symptom burden) that are associated with disruptions in healthy lifestyle practices. The steps of behavioral self-monitoring include: (1) selecting a goal, (2) paying attention to some aspect of behavior, and (3) recording some details of that behavior in a diary.
No Intervention: Usual Care
Participants randomized to this condition will receive the written education provided to all participants.
Experimental: LIfestyle + coaching
Behavioral self-monitoring of daily physical activity, dietary, and sleep behaviors, for 12 weeks, into an electronic tablet; and behavioral self-monitoring + motivational interviewing lifestyle coaching.
Behavioral: Behavioral self-monitoring + Motivational interviewing
Participants will receive the same Behavioral self-monitoring intervention; participants in this condition will interact with a 'lifestyle coach' about their recorded behaviors, weekly. The lifestyle coach will use motivational interviewing to enhance older adults' confidence and intrinsic motivation to engage in healthy lifestyle practices.
- Depressive symptoms (Hamilton Rating Scale of Depression [HRSD]) [ Time Frame: 12 months ]Symptom levels of depression (Hamilton Rating Scale of Depression [HRSD]),
- Anxiety symptoms (7-item Generalized Anxiety Disorder Scale [GAD-7]) [ Time Frame: 12 months ]Symptom levels of anxiety (7-item Generalized Anxiety Disorder Scale [GAD-7])
- Grief symptoms (Inventory of Complicated Grief [ICG]) [ Time Frame: 12 months ]Symptom levels of complicated grief (Inventory of Complicated Grief [ICG])
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631291
|Contact: Sarah T Stahl, PhDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Sarah Stahl, PhD 412-246-6003 email@example.com|
|Contact: James Emanuel, BA 412-246-6004 firstname.lastname@example.org|
|Principal Investigator:||Sarah Stahl, PhD||University of Pittsburgh|