Depression / Major Depressive DisorderCBTNCT07873905
Digital Single-Session Cognitive Behavioural Therapy in Healthy Adults
A study testing Digital single-session cognitive behavioural therapy and Digital memory task in people with Depression / Major Depressive Disorder and Anxiety, run by Brunel University at 1 site in United Kingdom.
Trial summary
The goal of this study is to learn if digital single-session cognitive behavioural therapy can treat mental health in adults. The main question it aims to answer is: Does digital single-session cognitive behavioural therapy improve mental health in participants? Researchers will compare digital single-session… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression / Major Depressive Disorder, Anxiety, Anxiety Disorder Generalized
- What is being tested?
- Digital single-session cognitive behavioural therapy and Digital memory task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Jul 2024to 10 Oct 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Specific problem or issue that is causing stress, low mood, or emotional difficulties.
- 18-65 years of age.
Who cannot join
- Current mental health condition as diagnosed by a GP or Psychiatrist.
- Taking psychotropic medication for a psychologically related condition.
- Self-harm.
- Suicide ideation and/or intent.
- Previous or current epilepsy.
- Severe visual impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Single-Session Cognitive Behavioural Therapy in Healthy Adults: A Randomised Controlled Trial
The goal of this study is to learn if digital single-session cognitive behavioural therapy can treat mental health in adults. The main question it aims to answer is:
- Does digital single-session cognitive behavioural therapy improve mental health in participants?
Researchers will compare digital single-session cognitive behavioural therapy to a control intervention (digital memory task) to see if digital single-session cognitive behavioural therapy works to treat mental health.
Participants will:
- Complete either the digital single-session cognitive behavioural therapy or a digital memory task.
- Complete some mental health questionnaires.
- Being tested
- Digital single-session cognitive behavioural therapy, Digital memory task
- Medical subject headings
- Depression, Depressive Disorder, Major, Anxiety Disorders, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital single-session cognitive behavioural therapyBehavioural
Also called CBT, single session therapy
Participants complete one session of digital single-session therapy which takes approximately 45 minutes and is accessible via an online link.
Digital memory taskBehavioural
Participants complete one session of a digital memory task which take approximately 45 minutes and is accessible via an online link.
| Study group | Role | What they receive |
|---|---|---|
| Single-session cognitive behavioural therapy | Experimental | Participant will receive digital single-session cognitive behavioural therapy. Receives: Behavioral: Digital single-session cognitive behavioural therapy |
| Memory task | Sham comparator | Participant will receive a digital memory task. Receives: Behavioral: Digital memory task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in PHQ-9 scores at 45 minutes post-intervention
Evaluates depressive symptoms from 0 (no symptoms) to 27 (severe symptoms).
Measured: From baseline to 45 minutes post-intervention
Change from baseline in GAD-7 scores at 45 minutes post-intervention
Evaluates anxious symptoms from 0 (no symptoms) to 21 (severe symptoms).
Measured: From baseline to 45 minutes post-intervention
Change from baseline in ATQ-30 scores at 45 minutes post-intervention
Evaluates frequency of negative automatic thoughts from 30 (no symptoms) to 150 (severe symptoms).
Measured: From baseline to 45 minutes post-intervention
Change from baseline in AAQ-II scores at 45 minutes post-intervention
Evaluates avoidance from 7 (no symptoms) to 49 (severe symptoms).
Measured: From baseline to 45 minutes post-intervention
Change from baseline in NCBI scores at 45 minutes post-intervention
Evaluates negative core beliefs with higher mean scores representing increased negative core beliefs.
Measured: From baseline to 45 minutes post-intervention
Change from baseline in PANAS scores at 45 minutes post-intervention
Evaluates positive and negative affect from 10 to 50 with higher scores representing higher levels of positive affect and lower scores representing lower levels of negative affect, respective to their questions.
Measured: From baseline to 45 minutes post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start23 Jul 2024
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression / Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brunel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Dalton, Brunel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873905
- Sponsor's protocol ID
- 46635-MHR-Jul/2024- 52050-3
- Acronym
- CBT
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Single-Session Cognitive Behavioural Therapy in Healthy Adults: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07873905
- Acronym / sponsor ID
- CBT / 46635-MHR-Jul/2024- 52050-3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Brunel UniversityUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 14 Oct 2026 (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.
The goal of this study is to learn if digital single-session cognitive behavioural therapy can treat mental health in adults. The main question it aims to answer is:
- Does digital single-session cognitive behavioural therapy improve mental health in participants?
Researchers will compare digital single-session cognitive behavioural therapy to a control intervention (digital memory task) to see if digital single-session cognitive behavioural therapy works to treat mental health.
Participants will:
- Complete either the digital single-session cognitive behavioural therapy or a digital memory task.
- Complete some mental health questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-session cognitive behavioural therapy | Experimental | Behavioral: Digital single-session cognitive behavioural therapyParticipant will receive digital single-session cognitive behavioural therapy. |
| Memory task | Sham comparator | Behavioral: Digital memory taskParticipant will receive a digital memory task. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Specific problem or issue that is causing stress, low mood, or emotional difficulties.
- 18-65 years of age.
Key exclusion criteria (6 listed)
- Current mental health condition as diagnosed by a GP or Psychiatrist.
- Taking psychotropic medication for a psychologically related condition.
- Self-harm.
- Suicide ideation and/or intent.
- Previous or current epilepsy.
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 |
|---|---|---|
| Digital single-session cognitive behavioural therapyAlso: CBT, single session therapyParticipants complete one session of digital single-session therapy which takes approximately 45 minutes and is accessible via an online link. | Behavioural | Single-session cognitive behavioural therapy |
| Digital memory taskParticipants complete one session of a digital memory task which take approximately 45 minutes and is accessible via an online link. | Behavioural | Memory task |
Primary outcome
Change from baseline in PHQ-9 scores at 45 minutes post-intervention
Time frame: From baseline to 45 minutes post-intervention
Evaluates depressive symptoms from 0 (no symptoms) to 27 (severe symptoms).
Change from baseline in GAD-7 scores at 45 minutes post-intervention
Time frame: From baseline to 45 minutes post-intervention
Evaluates anxious symptoms from 0 (no symptoms) to 21 (severe symptoms).
Change from baseline in ATQ-30 scores at 45 minutes post-intervention
Time frame: From baseline to 45 minutes post-intervention
Evaluates frequency of negative automatic thoughts from 30 (no symptoms) to 150 (severe symptoms).
Change from baseline in AAQ-II scores at 45 minutes post-intervention
Time frame: From baseline to 45 minutes post-intervention
Evaluates avoidance from 7 (no symptoms) to 49 (severe symptoms).
Change from baseline in NCBI scores at 45 minutes post-intervention
Time frame: From baseline to 45 minutes post-intervention
Evaluates negative core beliefs with higher mean scores representing increased negative core beliefs.
Change from baseline in PANAS scores at 45 minutes post-intervention
Time frame: From baseline to 45 minutes post-intervention
Evaluates positive and negative affect from 10 to 50 with higher scores representing higher levels of positive affect and lower scores representing lower levels of negative affect, respective to their questions.
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 14 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be made available upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital single-session cognitive behavioural therapy and Digital memory task in people with Depression / Major Depressive Disorder and Anxiety, run by Brunel University at 1 site in United Kingdom.
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 2 inclusion and 6 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 14 Oct 2026. 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 Kingdom. 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. Some participants in this study may receive a placebo. 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?
Change from baseline in PHQ-9 scores at 45 minutes post-intervention (time frame: From baseline to 45 minutes post-intervention). The study lists 6 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 14 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.