NCT04723251

Brief Summary

This study will assess the feasibility and acceptability of a positive psychology intervention, The Gratitude Gallery, for increasing gratitude in adults. The study hypothesizes that participants will find the activity feasible and acceptable and complete the intervention as directed. The project also hypothesizes that those that complete the intervention will show an increase in self-reported gratitude, as well as a decrease in symptoms of anxiety and depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 16, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2021

Completed
Last Updated

December 17, 2021

Status Verified

December 1, 2021

Enrollment Period

8 months

First QC Date

January 20, 2021

Last Update Submit

December 15, 2021

Conditions

Keywords

PhotosPhotographyGratitude

Outcome Measures

Primary Outcomes (3)

  • Acceptability of the The Gratitude Gallery

    Number of participants that are eligible for the study compared to the number of patients that are enrolled. The higher the ratio of participants enrolled the higher acceptability.

    2 years

  • Feasibility of the The Gratitude Gallery

    Participants that complete 15 of the 21 intervention days will be considered to be feasible.

    up to 21 days (days of treatment)

  • Changes in the level of reported gratitude as measured by the Gratitude Questionnaire - 6 (GQ-6).

    This is a six question, self-reported survey designed to assess individual differences in the proneness to experience gratitude in daily life. The GQ-6 uses a 7-point Likert scale with responses that range from "strongly disagree" to "strongly agree". Questions 3 and 6 are reverse scored. A higher total score indicated higher levels of gratitude.

    Baseline, up to day 60

Secondary Outcomes (5)

  • Changes in positive and negative affect as measured by the Positive and Negative Affect Scale (PANAS) Scale

    Baseline, up to day 60

  • Changes in General Life Satisfaction - Fixed Form B from the NIH Toolbox

    Baseline, up to day 60

  • Changes in sleep quality using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form 4a

    Baseline, up to day 60

  • Changes in depressive symptoms using the Patient Health Questionnaire 9-Item (PHQ-9)

    Baseline, up to day 60

  • Changes in anxiety symptoms using the Generalized Anxiety scale (GAD-7)

    Baseline, up to day 60

Study Arms (1)

Taking Photographs

EXPERIMENTAL

Participants will be asked to take photos with their cell phone.

Behavioral: taking photographs

Interventions

Participants will photograph images (using a cell phone) that invoke a feeling of gratitude. At least 1 photograph (at any time of the day) should be taken for a period of three weeks. Once the photo images are captured, the participant should spend a moment looking at the image and reflecting on why they are grateful for the subject of the photograph.

Taking Photographs

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to read/understand English and give consent
  • Owns a smart phone capable of taking pictures
  • Willing and able to comply with all aspects of study procedures
  • PHQ-9 score greater or equal to 5 but less or equal to 14 with no suicidal ideation
  • Generalized anxiety disorder (GAD-7) score greater or equal to 0 but less or equal to 9
  • No plan to initiate a new program that could increase positive affect during the study period (e.g., psychotherapy, new exercise regimen, meditation classes)
  • If on medication then stable (at least 3 months) on dose or not on medication

You may not qualify if:

  • Having a psychotic disorder active suicidality or severe depressive or anxiety symptoms
  • Other factors that at the discretion of the investigators that would adversely affect study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Erin Hendriks, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Family Medicine

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 25, 2021

Study Start

March 16, 2021

Primary Completion

November 2, 2021

Study Completion

November 2, 2021

Last Updated

December 17, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations