The Patient Health Questionnaire-9 is the most widely used self-report measure of depression severity. This template has all nine items with their exact response scale, coded 0 to 3, plus a safety follow-up on item 9.
Free sandbox · No credit card · 21 CFR Part 11 aligned
PHQ-9 · Week 4
Over the last 2 weeks, how often have you been bothered by:
1. Little interest or pleasure in doing things
2. Feeling down, depressed, or hopeless
PHQ-9 at a glance
The instrument
The PHQ-9 is the depression module of the Patient Health Questionnaire, published by Kroenke, Spitzer and Williams in 2001. Each of its nine items maps to one of the nine DSM criteria for a major depressive episode, which is why it can be used both to screen for depression and to grade how severe it is. It takes most participants two to three minutes.
Clinical trials use the PHQ-9 in three ways: as an eligibility screen (to include or exclude participants with depression), as a safety measure in studies of treatments with central nervous system effects, and as an efficacy endpoint in depression and behavioural health studies. It is short enough to repeat at every visit, and its two-week recall period fits neatly into typical visit intervals.
Each item is scored 0 to 3 and the nine scores are summed for a total of 0 to 27. In Capture every answer is stored as its coded value with the label alongside, so the total is a straightforward sum in your analysis program, and the data dictionary in every export documents the coding. A tenth question asks how difficult the problems have made work, home life or relationships. It is not part of the score, but it is worth keeping because it describes functional impact.
In treatment studies, response is often defined as a reduction of at least 50% from baseline and remission as a score below 5. A change of about five points is frequently cited as clinically meaningful. Define whichever definitions you use in the statistical analysis plan before unblinding, along with how you will handle missing items.
The PHQ-8 drops item 9 and is scored 0 to 24 with the same cut-offs. It is used in settings where nobody can follow up a positive answer on self-harm, such as anonymous surveys. The PHQ-2 is the first two items only, used as a quick pre-screen. If your trial has clinicians who can act on item 9, use the full PHQ-9.
Week 4 total
14 / 27
All nine items
Every item uses the same four-point scale: not at all (0), several days (1), more than half the days (2), nearly every day (3). Recall period: the last two weeks.
| # | Item | Criterion |
|---|---|---|
| 1 | Little interest or pleasure in doing things | Anhedonia |
| 2 | Feeling down, depressed, or hopeless | Depressed mood |
| 3 | Trouble falling or staying asleep, or sleeping too much | Sleep disturbance |
| 4 | Feeling tired or having little energy | Fatigue |
| 5 | Poor appetite or overeating | Appetite change |
| 6 | Feeling bad about yourself, or that you are a failure or have let yourself or your family down | Worthlessness or guilt |
| 7 | Trouble concentrating on things, such as reading the newspaper or watching television | Concentration |
| 8 | Moving or speaking so slowly that other people could have noticed, or the opposite, being so fidgety or restless that you have been moving around a lot more than usual | Psychomotor change |
| 9 | Thoughts that you would be better off dead, or of hurting yourself in some way | Suicidal ideation |
The PHQ-9 was developed by Drs. Robert L. Spitzer, Janet B.W. Williams, Kurt Kroenke and colleagues, with an educational grant from Pfizer Inc. No permission is required to reproduce, translate, display or distribute it. Use an officially translated version for non-English speaking participants.
Safety follow-up
A positive answer on item 9 should never sit unread until the next monitoring visit. Add a custom-value edit check to item 9: any answer other than "Not at all" raises an auto-query in the site's action list, so the investigator can carry out the follow-up assessment your protocol defines and record it.
Edit checks / auto-queries
2Type
Range High
Operator
Greater than
Value
180
Priority: High
Type
Range Low
Operator
Less than
Value
80
Priority: Normal
Query raised automatically
Value 192 violates limit (180). Please verify.
Run it as ePRO
The PHQ-9 is a self-report questionnaire, so it belongs in the participant's hands. Capture sends a secure link by email or SMS that opens the questionnaire in the phone's browser, already tied to the participant's record. There is no app to install and no password to forget.
From: Capture.Study · Sleep and Recovery Study
Your questionnaire is ready
Hi Anna, your evening diary is open until midnight. Tap the button to start. The link signs you in, no password needed.
Open my tasksQuestions? Reply to reach your study site.
My tasks
Evening diary
Due tonight
Week 4 questionnaire
Opens Monday
Where it fits
The two-week recall period sets the natural rhythm: administer it at screening for eligibility, at baseline, then every two to four weeks. Place it on the schedule once and every site follows the same timing.
| Assessment | Scr | BL | W2 | W4 | W6 | W8 | W12 |
|---|---|---|---|---|---|---|---|
| PHQ-9 | |||||||
| GAD-7 | |||||||
| C-SSRS | |||||||
| Vital signs | |||||||
| AE review |
Copy the template into a sandbox study and send yourself the participant link.
Data quality
The PHQ-9 is simple, which makes the few ways it goes wrong easy to overlook. Most problems come from mixing administration modes, changing wording, or not planning for missing answers.
Self-completed and interviewer-administered PHQ-9 scores are close but not identical. Decide whether participants complete it themselves or a coordinator reads it aloud, and keep that the same for every participant and every visit.
The validation rests on the exact wording. Use official translations rather than translating locally, and do not shorten items to fit a screen: Capture's phone layout wraps long items instead.
A missing item changes the total. Set all nine items as required so participants cannot submit a partial questionnaire by accident, and define in the analysis plan what happens if a whole questionnaire is missed.
Because the recall period is two weeks, a questionnaire completed ten days late covers a different period than planned. Visit windows with reminders keep completion inside the interval the endpoint assumes.
Yes. The PHQ-9 was developed with an educational grant from Pfizer and no permission is required to reproduce, translate, display or distribute it.
Each of the nine items is scored 0 to 3 and the scores are summed, giving a total of 0 to 27. Bands are 0 to 4 minimal, 5 to 9 mild, 10 to 14 moderate, 15 to 19 moderately severe and 20 to 27 severe.
Answers are stored as coded values (0 to 3) with labels, and the export includes a data dictionary, so the total is a simple sum in your analysis program. Capture's built-in calculated fields cover clinical derivations such as BMI and eGFR.
Your protocol should define a follow-up, usually a clinician risk assessment. In Capture a custom-value edit check on item 9 raises an auto-query to the site so the follow-up is not missed.
Yes. It runs in the phone's browser from a secure link sent by email or SMS, with no app to install.
The PHQ-8 leaves out item 9 on thoughts of death or self-harm and is scored 0 to 24. It is used where a positive answer could not be followed up.
The last two weeks. Schedule it at intervals of about two weeks or longer so recall periods do not overlap.
Yes, in the free sandbox with the rest of the template library. You pay only when a study goes live.
Keep exploring
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The anxiety companion to the PHQ-9.
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EDC for behavioral health studies
Digital and behavioural interventions.
ePRO software
Run questionnaires on participant phones.
Mood tracker template
A daily diary alongside the PHQ-9.
Copy the template, schedule it and test it on your own phone. Free sandbox, no credit card.