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Completed

NCT Number: NCT04723251

The Gratitude Gallery - A Positive Psychology Intervention

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

taking photographs

Behavioral

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.

Primary outcomes

  1. Acceptability of the The Gratitude Gallery

    Time frame: 2 years

    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. Feasibility of the The Gratitude Gallery

    Time frame: up to 21 days (days of treatment)

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

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

    Time frame: Baseline, up to day 60

    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.

Secondary outcomes

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

    Time frame: Baseline, up to day 60

    The PANAS scale is a 20 item mood scale measuring the two primary dimensions of mood. Responses on a 5-point Likert Scale range from "very slightly or not at all" to "extremely". Positive affect and negative affect questions are grouped and scored separately. The PANAS has been shown to be sensitive to short-term fluctuations in mood in addition to showing stability over a longer (2-month) time period.

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

    Time frame: Baseline, up to day 60

    This is a brief 5-item questionnaire which can be administered to adults over the age of 18. It uses a 7-point Likert scale with responses that range from "strongly disagree" to "strongly agree". The scores for each question are added to create a raw score. This raw score is then converted to a T-score using a conversion table which represents the mean of the United States population.

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

    Time frame: Baseline, up to day 60

    This assessment consists of 4 items which measure sleep quality and sleep disturbances using a 5 point likert scale ranging in value from 1 to 5 with higher scores indicating greater sleep quality.

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

    Time frame: Baseline, up to day 60

    The PHQ-9 is a brief, self-administered questionnaire that scores each of the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for depression on a scale from 0 to 3. Response options include "not at all", "several days", more than half the days" and "nearly every day". It is a validated measure of depression severity. Scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively.

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

    Time frame: Baseline, up to day 60

    The GAD-7 is a self-reported questionnaire that assesses for the seven core symptoms of generalized anxiety disorder and severity. Response options include "not at all", "several days", more than half the days" and "nearly every day". GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 25, 2021
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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