Depression - Major Depressive DisorderNCT06878859
Preliminary Efficacy Trial of a Digital Intervention for Depression and Cannabis Use
A study testing Amplification of Positivity - Cannabis Use (AMP-C) in people with Depression - Major Depressive Disorder and Cannabis Use Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a digital intervention for co-occurring cannabis use and depression. Participants will be randomized to complete Amplification of Positivity - Cannabis Use (AMP-C) or symptom tracking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder, Cannabis Use Disorder, Mental Disorder
- What is being tested?
- Amplification of Positivity - Cannabis Use (AMP-C)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2026to 29 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years
- Resides in the United States
- Able to read and understand English and willing to provide informed consent/comply with the study protocol
- Moderate depressive symptom severity, as indicated by the Patient Health Questionnaire-9 (PHQ-9)
- Problematic cannabis use, as indicated by the Cannabis Use Disorder Identification Test - Revised (CUDIT-R)
- Current elevated anhedonia, as indicated by the PHQ-9
- Interest in receiving treatment for their cannabis use and depression
- Meet criteria for current MDD and CUD per the DSM-5
Who cannot join
- History of a psychotic disorder or bipolar disorder type I/II
- Active suicidal ideation or intent based on the Columbia-Suicide Severity Rating Scale
- Current psychotherapy engagement
- Changes in psychotropic medication within six weeks of the start of study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Shirley Wu, BS, 617-724-3532, swu24@mgh.harvard.edu
Amanda C Collins, PhD
About this study
Official title: AMP-C: A Digital Therapeutic for Reward Dysfunction in Co-Occurring Depression and Cannabis Use
The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a digital intervention for co-occurring cannabis use and depression. Participants will be randomized to complete Amplification of Positivity - Cannabis Use (AMP-C) or symptom tracking. The main outcomes will include changes in depressive symptoms and cannabis use, as well as usability ratings.
- Being tested
- Amplification of Positivity - Cannabis Use (AMP-C)
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amplification of Positivity - Cannabis Use (AMP-C)Behavioural
AMP-C is a smartphone-based digital intervention that includes activities that focus on positivity (e.g., noticing and capitalizing on positive events) to increase positive emotions, thoughts, and behaviors. The role and impact of CU on the maintenance of depression and reward dysfunction (and vice versa), is intertwined throughout the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Amplification of Positivity - Cannabis Use (AMP-C) | Experimental | Not described Receives: Behavioral: Amplification of Positivity - Cannabis Use (AMP-C) |
| Symptom Tracking | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depressive Symptoms (Patient Health Questionnaire-9; PHQ-9)
Depressive symptoms will be measured with the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a widely-used 9-item self-report measure that assesses depressive symptom severity over the previous two weeks. Scores on the PHQ-9 range from 0-27, with greater scores indicating greater depression severity.
Measured: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: Intervention Midpoint (4 weeks into intervention), 1-, 3-, 6-, and 12-months after completing intervention
Change in Cannabis Use Frequency (Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory; DFAQ-CU)
Cannabis use use will be measured with the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU). The DFAQ-CU is a 24-item self-report measure that assesses frequency, age of onset, and quantity of cannabis use. There are six factors: daily sessions, frequency, age of onset, marijuana quantity, concentrate quantity, and edible quantity. The six factors, except age of onset, are independently scored, and higher scores indicate greater cannabis use. Our primary outcome will assess changes in frequency.
Measured: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: Intervention Midpoint (4 weeks into intervention), 1-, 3-, 6-, and 12-months after completing intervention
Usability (System Usability Scale; SUS)
The System Usability Scale (SUS) is a 10-item self-report measure commonly used to assess the degree to which participants endorse ease of use following task-based operation of computer systems (i.e., perceived usability). Total scores on the SUS range from 0 to 100, with greater scores indicating greater usability. An average score of 68 or greater on the SUS in our AMP-C group will indicate acceptable usability.
Measured: Post-Intervention (approximately one week after completing intervention)
Secondary outcomes (8)
Feasibility (Engagement)
Feasibility will be measured through the number of modules completed for the AMP-C group.
Measured: Post-Intervention (approximately one week after completing intervention)
Intervention Feasibility (App Usage)
Feasibility will be measured through app usage time (hours).
Measured: Post-Intervention (approximately one week after completing intervention)
Change in Daily Depressive Symptoms (Mobile Patient Health Questionnaire-9; MPHQ-9)
Daily depressive symptoms will be measured with the Mobile Patient Health Questionnaire-9 (MPHQ-9). The MPHQ-9 is a modified version of the paper PHQ-9, which has been used in intensive sampling studies. Participants answer questions regarding their experience with the nine symptoms of MDD over the past 24 hours on a sliding scale. Total scores range from 0-900, with greater scores representing greater depression severity.
Measured: Daily for 8 weeks during intervention
Changes in Daily Cannabis Use
Daily cannabis use will be measured with a series of questions related to cannabis use consumption. These questions will capture frequency, quantity, product types, potencies, and administration methods of cannabis over the past 24 hours.
Measured: Daily for 8 weeks during intervention
Change in Positive Affect (Positive and Negative Affect Schedule-Positive Affect; PANAS-PA)
The Positive and Negative Affect Schedule Scale-Positive Affect (PANAS-PA) is a 10-item self-report measure that assesses positive affect over the past week. Total scores range from 10-50, with greater scores representing greater positive affect.
Measured: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: Intervention Midpoint (4 weeks into intervention), 1-, 3-, 6-, and 12-months after completing intervention
Change in Anticipatory and Consummatory Anhedonia (Temporal Experience of Pleasure Scale; TEPS)
Anticipatory and consummatory anhedonia will be measured with the Temporal Experience of Pleasure Scale (TEPS). The TEPS is a 18-item self-report measure that assesses reward anticipation (e.g., motivation) and responsiveness (e.g., pleasure). There are two subscales in the TEPS: anticipatory anhedonia and consummatory anhedonia. Scores on the anticipatory subscale range from 10 to 60, and scores on the consummatory subscale range from 8 to 48. Higher scores indicate greater pleasure.
Measured: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention
Change in Negative Affect (Positive and Negative Affect Schedule-Negative Affect; PANAS-NA)
The Positive and Negative Affect Schedule Scale-Negative Affect (PANAS-NA) is a 10-item self-report measure that assesses negative affect over the past week. Total scores range from 10-50, with greater scores representing greater negative affect.
Measured: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention
Changes in passively assessed behavioral activation
Passive sensing behaviors will be continuously collected without requiring participant input and will be related to behavioral activation (measured through GPS mobility). Changes in behaviors (e.g., increased GPS mobillity) will indicate greater behavioral activation during the course of the intervention for the AMP-C group.
Measured: Continuously for 8 weeks during intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start23 Feb 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion29 Jun 2029 (estimated)
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.
- More trials run by Massachusetts General HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Amanda C. Collins, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878859
- Sponsor's protocol ID
- 2025p000583
- Other IDs
- 1K23DA062034
- Status last verified
- May 2026
- First submitted
- 6 Mar 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMP-C: A Digital Therapeutic for Reward Dysfunction in Co-Occurring Depression and Cannabis Use
- ClinicalTrials.gov ID
- NCT06878859
- Acronym / sponsor ID
- 2025p000583
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 29 Jun 2029 (estimated)
- First posted
- 17 Mar 2025 (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 purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a digital intervention for co-occurring cannabis use and depression. Participants will be randomized to complete Amplification of Positivity - Cannabis Use (AMP-C) or symptom tracking. The main outcomes will include changes in depressive symptoms and cannabis use, as well as usability ratings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amplification of Positivity - Cannabis Use (AMP-C) | Experimental | Behavioral: Amplification of Positivity - Cannabis Use (AMP-C) |
| Symptom Tracking | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥ 18 years
- Resides in the United States
- Able to read and understand English and willing to provide informed consent/comply with the study protocol
- Moderate depressive symptom severity, as indicated by the Patient Health Questionnaire-9 (PHQ-9)
- Problematic cannabis use, as indicated by the Cannabis Use Disorder Identification Test - Revised (CUDIT-R)
Key exclusion criteria (4 listed)
- History of a psychotic disorder or bipolar disorder type I/II
- Active suicidal ideation or intent based on the Columbia-Suicide Severity Rating Scale
- Current psychotherapy engagement
- Changes in psychotropic medication within six weeks of the start of study
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 |
|---|---|---|
| Amplification of Positivity - Cannabis Use (AMP-C)AMP-C is a smartphone-based digital intervention that includes activities that focus on positivity (e.g., noticing and capitalizing on positive events) to increase positive emotions, thoughts, and behaviors. The role and impact of CU on the maintenance of depression and reward dysfunction (and vice versa), is intertwined throughout the intervention. | Behavioural | Amplification of Positivity - Cannabis Use (AMP-C) |
Primary outcome
Change in Depressive Symptoms (Patient Health Questionnaire-9; PHQ-9)
Time frame: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: Intervention Midpoint (4 weeks into intervention), 1-, 3-, 6-, and 12-months after completing intervention
Depressive symptoms will be measured with the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a widely-used 9-item self-report measure that assesses depressive symptom severity over the previous two weeks. Scores on the PHQ-9 range from 0-27, with greater scores indicating greater depression severity.
Change in Cannabis Use Frequency (Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory; DFAQ-CU)
Time frame: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: Intervention Midpoint (4 weeks into intervention), 1-, 3-, 6-, and 12-months after completing intervention
Cannabis use use will be measured with the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU). The DFAQ-CU is a 24-item self-report measure that assesses frequency, age of onset, and quantity of cannabis use. There are six factors: daily sessions, frequency, age of onset, marijuana quantity, concentrate quantity, and edible quantity. The six factors, except age of onset, are independently scored, and higher scores indicate greater cannabis use. Our primary outcome will assess changes in frequency.
Usability (System Usability Scale; SUS)
Time frame: Post-Intervention (approximately one week after completing intervention)
The System Usability Scale (SUS) is a 10-item self-report measure commonly used to assess the degree to which participants endorse ease of use following task-based operation of computer systems (i.e., perceived usability). Total scores on the SUS range from 0 to 100, with greater scores indicating greater usability. An average score of 68 or greater on the SUS in our AMP-C group will indicate acceptable usability.
8 secondary outcomes
Feasibility (Engagement)
Time frame: Post-Intervention (approximately one week after completing intervention)
Intervention Feasibility (App Usage)
Time frame: Post-Intervention (approximately one week after completing intervention)
Change in Daily Depressive Symptoms (Mobile Patient Health Questionnaire-9; MPHQ-9)
Time frame: Daily for 8 weeks during intervention
Changes in Daily Cannabis Use
Time frame: Daily for 8 weeks during intervention
Change in Positive Affect (Positive and Negative Affect Schedule-Positive Affect; PANAS-PA)
Time frame: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: Intervention Midpoint (4 weeks into intervention), 1-, 3-, 6-, and 12-months after completing intervention
Change in Anticipatory and Consummatory Anhedonia (Temporal Experience of Pleasure Scale; TEPS)
Time frame: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention
Change in Negative Affect (Positive and Negative Affect Schedule-Negative Affect; PANAS-NA)
Time frame: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention
Changes in passively assessed behavioral activation
Time frame: Continuously for 8 weeks during intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amplification of Positivity - Cannabis Use (AMP-C) in people with Depression - Major Depressive Disorder and Cannabis Use Disorder, run by Massachusetts General Hospital 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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Jun 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive Symptoms (Patient Health Questionnaire-9; PHQ-9) (time frame: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: Intervention Midpoint (4 weeks into intervention), 1-, 3-, 6-, and 12-months after completing intervention). 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 2 Jun 2026.