DepressionNCT04723251
The Gratitude Gallery - A Positive Psychology Intervention
A study testing taking photographs in people with Depression and Anxiety, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- taking photographs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2021to 2 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Depression, Anxiety
- Being tested
- taking photographs
- Keywords
- Photos, Photography, Gratitude
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taking photographsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Taking Photographs | Experimental | Participants will be asked to take photos with their cell phone. Receives: Behavioral: taking photographs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Feasibility of the The Gratitude Gallery
Participants that complete 15 of the 21 intervention days will be considered to be feasible.
Measured: 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.
Measured: 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
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.
Measured: Baseline, up to day 60
Changes in General Life Satisfaction - Fixed Form B from the NIH Toolbox
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.
Measured: Baseline, up to day 60
Changes in sleep quality using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form 4a
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.
Measured: Baseline, up to day 60
Changes in depressive symptoms using the Patient Health Questionnaire 9-Item (PHQ-9)
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.
Measured: Baseline, up to day 60
Changes in anxiety symptoms using the Generalized Anxiety scale (GAD-7)
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.
Measured: Baseline, up to day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start16 Mar 2021
- Primary completion2 Nov 2021
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Hendriks, University of Michigan
- Investigators
- Erin Hendriks, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723251
- Sponsor's protocol ID
- HUM00177310
- Status last verified
- Dec 2021
- First submitted
- 20 Jan 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gratitude Gallery - A Positive Psychology Intervention
- ClinicalTrials.gov ID
- NCT04723251
- Acronym / sponsor ID
- HUM00177310
- Conditions
- Depression, Anxiety
- Keywords
- Photos, Photography, Gratitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taking Photographs | Experimental | Behavioral: taking photographsParticipants will be asked to take photos with their cell phone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taking photographsParticipants 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. | Behavioural | Taking Photographs |
Primary outcome
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.
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.
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.
5 secondary outcomes
Changes in positive and negative affect as measured by the Positive and Negative Affect Scale (PANAS) Scale
Time frame: Baseline, up to day 60
Changes in General Life Satisfaction - Fixed Form B from the NIH Toolbox
Time frame: Baseline, up to day 60
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
Changes in depressive symptoms using the Patient Health Questionnaire 9-Item (PHQ-9)
Time frame: Baseline, up to day 60
Changes in anxiety symptoms using the Generalized Anxiety scale (GAD-7)
Time frame: Baseline, up to day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Hendriks, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taking photographs in people with Depression and Anxiety, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the The Gratitude Gallery (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.