The HADS screens for anxiety and depression in people with physical illness, and leaves out the somatic symptoms that illness itself causes. This page covers its structure, scoring and licensing, and how to build it so participants answer on their own phone.
Free sandbox · No credit card · 21 CFR Part 11 aligned
HADS · Week 6
Subject 004-0031 · Demo study · last week
Item 1 (anxiety subscale)
Four labelled answers, item-specific
Item 2 (depression subscale)
Four labelled answers, item-specific
HADS at a glance
Licensing
Licence requiredRights holder: GL AssessmentThe HADS is copyrighted, with all rights reserved to GL Assessment, and must not be used without permission. A licence agreement and usage fees normally apply. Licensees outside the UK, the Republic of Ireland and the Channel Islands request it through Mapi Research Trust's ePROVIDE portal, which handles GL Assessment instruments.
In Capture: Capture doesn't supply this instrument or a licence for it. Once you have both, enter the official wording yourself, then switch on "Licence required" in the questionnaire's settings and record the licence number and expiry. Staff see a "copyright approval pending" watermark until you do, and Capture stops new data collection on the questionnaire after the recorded expiry date.
Mapi Research Trust (ePROVIDE)Instrument names belong to their rights holders, and Capture is not affiliated with or endorsed by them. Terms change, so confirm them with the rights holder before your study starts. This is general information, not legal advice.
The instrument
Most depression and anxiety questionnaires were written for psychiatric populations and count symptoms such as poor sleep, low energy and reduced appetite. In someone with cancer, heart failure or COPD those symptoms are often the disease or its treatment, so a general scale can overstate distress. The HADS was built to avoid this: its items focus on anhedonia and on anxious and depressed mood, not on bodily symptoms. That is why it appears so often in oncology, cardiology, respiratory and chronic pain studies.
In trials it serves as a screening tool at enrolment, as a secondary endpoint for supportive-care and psychological interventions, and as a monitoring measure in studies where a treatment may affect mood. For a general-population depression endpoint, the PHQ-9 and GAD-7 are free to reproduce and more commonly used; the WHO-5 measures wellbeing instead. Choose the HADS when the literature in your population already reports it, so your results compare directly.
Odd-numbered items belong to the anxiety subscale and even-numbered items to the depression subscale. Each item is scored 0 to 3, with the direction of scoring reversed on some items, so a higher number always means more distress. Each subscale is the sum of its seven items. Capture stores every answer as its coded value with the label alongside. Subscale totals are not among Capture's built-in calculated fields (which cover BMI, eGFR, QTc and similar clinical derivations), so the sums and the cut-off categories are derived in your analysis program from the export, using the scoring key from the licensed manual.
Published practice for handling a missing item varies, for example prorating a subscale when a single item is missing. State your rule in the statistical analysis plan. Making every item required on the form removes most of the problem.
Week 6 anxiety score
9 / 21
Structure
| Element | Detail |
|---|---|
| Items | 14: 7 anxiety (odd-numbered), 7 depression (even-numbered) |
| Item scoring | 0 to 3 per item, with an item-specific set of four answers |
| Subscale range | 0 to 21 for anxiety and 0 to 21 for depression, scored separately |
| Recall period | The past week |
| Cut-offs (each subscale) | 0 to 7 normal, 8 to 10 borderline, 11 to 21 abnormal |
| Who completes it | The participant, on paper or electronically |
| What it leaves out | Somatic symptoms such as fatigue, sleep and appetite |
| Rights holder | GL Assessment (licence required, see below) |
Structure only. Get the items, answer options, scoring key and translations from the licensed HADS materials.
Run it as ePRO
The HADS is self-report, so it belongs in the participant's hands. Capture sends a secure link by email or SMS that opens in the phone browser, tied to the participant's record. There is no app to install.
Evening diary
Question 3 of 8
How would you rate your fatigue today?
0 = no fatigue, 10 = worst imaginable
Licensing
On a participant questionnaire the study team can switch on "Licence required" and record the licence number, holder and expiry. Until the number and expiry are entered, staff see a "copyright approval pending" watermark in the builder, preview and PDF. Nothing is blocked while details are missing, so the discipline is yours. After the recorded expiry date no new tasks are generated and submissions are rejected, with an amber warning for staff 30 days before. Capture does not verify licences with rights holders and does not supply the HADS wording.
Copyright & licence
Approval pendingLicence number
Not recorded
Expiry date
Not recorded
Watermark shown to staff only. Participants never see it.
Build the form in the free sandbox with placeholder items, schedule it and open the participant link before your licensed wording arrives.
How to build it
Request the HADS from GL Assessment. Outside the UK, the Republic of Ireland and the Channel Islands, requests go through Mapi Research Trust's ePROVIDE portal. State your countries, languages and whether the study is commercial or academic.
Add 14 items as single-choice questions with the licensed answer labels and coded values 0 to 3, keeping item order exactly as in the source.
Prevent partial submissions so the subscale sums are always complete.
Switch on "Licence required", then enter number, holder and expiry. Keep the signed agreement with the study documents.
Place it on the visit schedule and set a completion window. A one-week recall period suits visits spaced one week or more apart.
If a score of 11 or more needs clinician review, say so in the protocol and add a custom-value edit check on the relevant items so the site is prompted, then test it in the sandbox.
Before go-live
Obtained from GL Assessment or via ePROVIDE for each country and language.
Use the rights holder's translations rather than translating locally.
Keep item text, answer options and order exactly as licensed.
Anxiety and depression are never summed into one number.
Write the rule for a missing item and for a missed questionnaire in the analysis plan.
The protocol states who acts on a score of 11 or more and how it is recorded, for example on the adverse event form where required.
No. The HADS is copyrighted and licensed by GL Assessment, and a licence agreement with fees is normally needed. Outside the UK, Ireland and the Channel Islands, requests go through Mapi Research Trust's ePROVIDE portal. Confirm current terms with the licensor.
Each of the 14 items is scored 0 to 3. Seven odd-numbered items form the anxiety subscale and seven even-numbered items the depression subscale, each totalled 0 to 21. Cut-offs per subscale are 0 to 7 normal, 8 to 10 borderline and 11 to 21 abnormal.
No. Capture stores coded item values and exports a data dictionary with them. The subscale sums are derived in your analysis program, because Capture's calculated fields are a fixed set of clinical derivations such as BMI and eGFR.
The HADS avoids somatic symptoms that physical illness can cause, which suits medically ill populations. The PHQ-9 and GAD-7 are free to reproduce and widely used in general settings. Pick the one your population's literature uses.
No. Capture does not supply licensed instruments or their wording. You obtain the items under your licence and build them in the form.
Yes, in the phone browser from a secure link sent by email or SMS, with no app to install, as long as your licence covers electronic administration.
The past week.
Keep exploring
PHQ-9 eCRF template
Free depression severity scale.
GAD-7 eCRF template
Free anxiety severity scale.
WHO-5 eCRF template
Short wellbeing index.
DASS-21 eCRF template
Depression, anxiety and stress subscales.
EDC for psychiatry trials
Rating scales and safety in CNS studies.
ePRO software
Run questionnaires on participant phones.
Build the form, record your licence and test the participant link. Free sandbox, no credit card.