DepressionNCT06488859
Affect Treatment for Depression and Anxiety (TAD Pilot)
A study testing Positive Affect Treatment and Positive Affect Treatment and Negative Affect Treatment in people with Depression and Anxiety, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
The goal of this study is to determine whether subjects who do not show expected clinical improvement during the early course of positive affect treatment (PAT) would benefit from switching to an alternative psychosocial treatment (negative affect treatment) that is designed to instead target and improve deficits in… 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?
- Positive Affect Treatment and Positive Affect Treatment and Negative Affect Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Mar 2024to 25 Mar 2025
- 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
- English-speaking
- Low positive affect indexed by less than or equal to 24 on the positive affect subscale of the PANAS (i.e., PANAS-P); and scores of greater than or equal to 11 for depression and greater to or equal to 6 for anxiety on the Depression, Anxiety, and Stress Scale.
- Score of greater than or equal to 4 on any WSAS subscale
- Willingness to refrain from starting other psychosocial or pharmacological treatments until study completion.
Who cannot join
- Patient report of serious medical conditions - such as history of serious, uncontrolled medical illness, or instability (including significant cardio-pulmonary disease, organic brain syndrome, seizure disorder, cerebrovascular disease, thyroid dysfunction, and diabetes)
- Current active suicidal ideation
- Lifetime history of bipolar disorder, psychosis, cognitive impairment, or organic brain damage
- Substance use disorder (including smoking) within the last 6 months. History of cocaine or stimulate use (e.g., amphetamine, cocaine, methamphetamine)
- Greater than 11 cigarettes per week or nicotine equivalent
- History of marijuana, cocaine or stimulant use 5-7 times/week or more before age 15 (e.g., amphetamine, cocaine, methamphetamine)
Show all 12Show fewer
- Willingness to refrain from marijuana use 1 week before laboratory assessments
- Pregnancy
- Bupropion, dopaminergic or neuroleptic medications use in the past 6 months
- Heterocyclics and SSRIs are permitted if stabilized (3 months) and PRN benzodiazepines and beta-blockers are permitted but discouraged on laboratory assessment visits
- Refusal of video/audio-taping
- Prior participation in previous waves of this study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Southern Methodist University
Dallas, Texas, 75205
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Affective Treatment Study
The goal of this study is to determine whether subjects who do not show expected clinical improvement during the early course of positive affect treatment (PAT) would benefit from switching to an alternative psychosocial treatment (negative affect treatment) that is designed to instead target and improve deficits in threat sensitivity.
Participants will complete laboratory tests, psychiatric assessments, and self-report questionnaires as part of the study.
The total length of participation is around 5 months.
Read the detailed description
Anhedonia, or loss of interest or pleasure in usual activities, is characteristic of depression, some types of anxiety, as well as substance abuse and schizophrenia. Specifically, anhedonia is associated with deficits in the appetitive reward system. Previously, our team developed a novel transdiagnostic psychosocial treatment for anhedonia that was designed to specifically target and improve deficits in reward sensitivity: Positive Affect Treatment (PAT). In clinical trials, PAT has been proven to be clinically effective at increasing positive affect, reducing negative affect, and improving depression, anxiety and stress (Craske et al., 2019, Craske et al., 2023). Like all psychosocial interventions, however, PAT is not effective for every individual. The goal of the current study is to determine whether subjects who do not show expected clinical improvement during the early course of PAT would benefit from switching to an alternative psychosocial treatment (Negative Affect Treatment [NAT]) that is designed to instead target and improve deficits in threat sensitivity.
Upon enrollment, each participant will complete a two-week long baseline assessment period before beginning treatment. On the first day of the baseline period, participants will complete a brief anhedonia interview, which will be conducted by an independent interviewer over the phone or HIPAA-compliant Zoom. For this interview, participants will answer 3 items using a 4-point rating scale, which will then be rated by the interviewer. In addition, participants will complete a battery of psychosocial questionnaires (approx. 25 minutes) remotely via REDCap to assess their mood, current symptoms and impairment. The participant will complete this assessment (including the clinical interview and questionnaires) a total of four times throughout the study: (1) the first day of the baseline period, (2) just before their first treatment session (i.e., the last day of the baseline period), (3) at the point of switching to the second treatment stage, and (4) just after completing treatment. In addition, beginning on the first day of their baseline period and throughout the remainder of their participation, subjects will be asked to provide daily mood ratings using a 0-10 scale.
Following the baseline period, participants will receive weekly 60-minute individual therapy sessions remotely (via HIPAA-compliant Zoom) with a highly trained psychotherapist. Before each session, participants will complete a short (approx. 7-10 minutes) series of surveys/questions to monitor their symptoms and other important clinical changes.
All participants will receive a variation of the same treatment (PAT), however, participants who do not show the expected clinical improvement during the first 3-5 sessions of PAT will be switched to an alternative treatment (NAT). Participants who show clinical improvement in response to PAT will receive a total of 8 weeks of therapy. Participants who fail to show signs of clinical improvement in response to the first 3-5 sessions of PAT will discontinue PAT and begin NAT; they will receive a total of 8 weeks of therapy with NAT (in addition to the 3-5 weeks of therapy with PAT that they already completed).
- Conditions
- Depression, Anxiety
- Being tested
- Positive Affect Treatment, Positive Affect Treatment and Negative Affect Treatment
- 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.
Positive Affect TreatmentBehavioural
Sessions 1-8: Pleasurable activities + imaginal recounting and reinforcement of positive mood effects
Positive Affect Treatment and Negative Affect TreatmentBehavioural
Sessions 1-4: Pleasurable activities + imaginal recounting and reinforcement of positive mood effects Sessions 5-8: Exposure therapy to feared or avoided situations, sensations, or memories
| Study group | Role | What they receive |
|---|---|---|
| Positive Affect Treatment | Experimental | 8 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning. Receives: Behavioral: Positive Affect Treatment |
| Positive Affect Treatment and Negative Affect Treatment | Active comparator | 8 sessions of psychotherapy. 3-5 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning. Remaining sessions of psychotherapy designed to decrease threat avoidance, threat appraisal and arousal. Receives: Behavioral: Positive Affect Treatment and Negative Affect Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Affect Schedule Expanded (PANAS-X) (General Dimensions Scales)
Reported positive affect (general dimensions scale positive affect) and negative affect (general dimension scale negative affect) (score range for each scale: 10-50), higher scores represent higher levels of positive affect or negative affect).
Measured: Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)
Depression Anxiety and Stress Scale (DASS-21)
Reported symptoms of depression (score range: 0-21), anxiety (score range: 0-21), and stress (score range: 0-21), higher scores indicate higher severity and frequency.
Measured: Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)
Secondary outcomes (6)
Interviewer Anhedonia Ratings
Interviewer ratings of interest, pleasure, and motivation in hobbies/pastimes, foods/drinks, social activities (score range: 1-12), higher scores indicate lower anhedonia
Measured: Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)
Behavioral Inhibition/Behavioral Activation (reward drive subscale) (BAS-RD)
Mediator: Reported reward sensitivity (score range: 4-16), and threat sensitivity (score range: 7-28), with higher scores indicating higher sensitivity
Measured: Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)
Beck Depression Inventory (BDI-9)
Reported suicidal ideation (score range: 0-3), higher scores indicate higher suicidality
Measured: Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)
Temporal Experience of Pleasure Scale (TEPS)
Change in reported anticipatory pleasure (score range: 10-60) and consummatory pleasure (score range: 8-48), higher scores indicate higher reward responsiveness
Measured: Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)
Dimensional Anhedonia Rating Scale (DARS)
Reported desire, motivation, effort, and consummatory pleasure across hedonic domains (score range: 0-104), higher scores indicate lower anhedonia
Measured: Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)
Work and Social Adjustment Scale (WSAS)
Reported impairment at work, home, and in relationships (score range: 0-40), higher scores indicate higher impairment
Measured: Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start25 Mar 2024
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
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 California, Los AngelesThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Methodist University
- Responsible party
- Principal investigator, Michelle Craske, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488859
- Sponsor's protocol ID
- TAD Pilot
- Status last verified
- May 2025
- First submitted
- 24 Jun 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affective Treatment Study
- ClinicalTrials.gov ID
- NCT06488859
- Acronym / sponsor ID
- TAD Pilot
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Southern Methodist University
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 5 Jul 2024 (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 determine whether subjects who do not show expected clinical improvement during the early course of positive affect treatment (PAT) would benefit from switching to an alternative psychosocial treatment (negative affect treatment) that is designed to instead target and improve deficits in threat sensitivity.
Participants will complete laboratory tests, psychiatric assessments, and self-report questionnaires as part of the study.
The total length of participation is around 5 months.
Detailed description
Anhedonia, or loss of interest or pleasure in usual activities, is characteristic of depression, some types of anxiety, as well as substance abuse and schizophrenia. Specifically, anhedonia is associated with deficits in the appetitive reward system. Previously, our team developed a novel transdiagnostic psychosocial treatment for anhedonia that was designed to specifically target and improve deficits in reward sensitivity: Positive Affect Treatment (PAT). In clinical trials, PAT has been proven to be clinically effective at increasing positive affect, reducing negative affect, and improving depression, anxiety and stress (Craske et al., 2019, Craske et al., 2023). Like all psychosocial interventions, however, PAT is not effective for every individual. The goal of the current study is to determine whether subjects who do not show expected clinical improvement during the early course of PAT would benefit from switching to an alternative psychosocial treatment (Negative Affect Treatment [NAT]) that is designed to instead target and improve deficits in threat sensitivity.
Upon enrollment, each participant will complete a two-week long baseline assessment period before beginning treatment. On the first day of the baseline period, participants will complete a brief anhedonia interview, which will be conducted by an independent interviewer over the phone or HIPAA-compliant Zoom. For this interview, participants will answer 3 items using a 4-point rating scale, which will then be rated by the interviewer. In addition, participants will complete a battery of psychosocial questionnaires (approx. 25 minutes) remotely via REDCap to assess their mood, current symptoms and impairment. The participant will complete this assessment (including the clinical interview and questionnaires) a total of four times throughout the study: (1) the first day of the baseline period, (2) just before their first treatment session (i.e., the last day of the baseline period), (3) at the point of switching to the second treatment stage, and (4) just after completing treatment. In addition, beginning on the first day of their baseline period and throughout the remainder of their participation, subjects will be asked to provide daily mood ratings using a 0-10 scale.
Following the baseline period, participants will receive weekly 60-minute individual therapy sessions remotely (via HIPAA-compliant Zoom) with a highly trained psychotherapist. Before each session, participants will complete a short (approx. 7-10 minutes) series of surveys/questions to monitor their symptoms and other important clinical changes.
All participants will receive a variation of the same treatment (PAT), however, participants who do not show the expected clinical improvement during the first 3-5 sessions of PAT will be switched to an alternative treatment (NAT). Participants who show clinical improvement in response to PAT will receive a total of 8 weeks of therapy. Participants who fail to show signs of clinical improvement in response to the first 3-5 sessions of PAT will discontinue PAT and begin NAT; they will receive a total of 8 weeks of therapy with NAT (in addition to the 3-5 weeks of therapy with PAT that they already completed).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Affect Treatment | Experimental | Behavioral: Positive Affect Treatment8 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning. |
| Positive Affect Treatment and Negative Affect Treatment | Active comparator | Behavioral: Positive Affect Treatment and Negative Affect Treatment8 sessions of psychotherapy. 3-5 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning. Remaining sessions of psychotherapy designed to decrease threat avoidance, threat appraisal and arousal. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English-speaking
- Low positive affect indexed by less than or equal to 24 on the positive affect subscale of the PANAS (i.e., PANAS-P); and scores of greater than or equal to 11 for depression and greater to or equal to 6 for anxiety on the Depression, Anxiety, and Stress Scale.
- Score of greater than or equal to 4 on any WSAS subscale
- Willingness to refrain from starting other psychosocial or pharmacological treatments until study completion.
Key exclusion criteria (12 listed)
- Patient report of serious medical conditions - such as history of serious, uncontrolled medical illness, or instability (including significant cardio-pulmonary disease, organic brain syndrome, seizure disorder, cerebrovascular disease, thyroid dysfunction, and diabetes)
- Current active suicidal ideation
- Lifetime history of bipolar disorder, psychosis, cognitive impairment, or organic brain damage
- Substance use disorder (including smoking) within the last 6 months. History of cocaine or stimulate use (e.g., amphetamine, cocaine, methamphetamine)
- Greater than 11 cigarettes per week or nicotine equivalent
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 |
|---|---|---|
| Positive Affect TreatmentSessions 1-8: Pleasurable activities + imaginal recounting and reinforcement of positive mood effects | Behavioural | Positive Affect Treatment |
| Positive Affect Treatment and Negative Affect TreatmentSessions 1-4: Pleasurable activities + imaginal recounting and reinforcement of positive mood effects Sessions 5-8: Exposure therapy to feared or avoided situations, sensations, or memories | Behavioural | Positive Affect Treatment and Negative Affect Treatment |
Primary outcome
Positive and Negative Affect Schedule Expanded (PANAS-X) (General Dimensions Scales)
Time frame: Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)
Reported positive affect (general dimensions scale positive affect) and negative affect (general dimension scale negative affect) (score range for each scale: 10-50), higher scores represent higher levels of positive affect or negative affect).
Depression Anxiety and Stress Scale (DASS-21)
Time frame: Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)
Reported symptoms of depression (score range: 0-21), anxiety (score range: 0-21), and stress (score range: 0-21), higher scores indicate higher severity and frequency.
6 secondary outcomes
Interviewer Anhedonia Ratings
Time frame: Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)
Behavioral Inhibition/Behavioral Activation (reward drive subscale) (BAS-RD)
Time frame: Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)
Beck Depression Inventory (BDI-9)
Time frame: Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)
Temporal Experience of Pleasure Scale (TEPS)
Time frame: Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)
Dimensional Anhedonia Rating Scale (DARS)
Time frame: Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)
Work and Social Adjustment Scale (WSAS)
Time frame: Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)
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 11 May 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Affect Treatment and Positive Affect Treatment and Negative Affect Treatment in people with Depression and Anxiety, run by University of California, Los Angeles at 2 sites 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 4 inclusion and 12 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 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Positive and Negative Affect Schedule Expanded (PANAS-X) (General Dimensions Scales) (time frame: Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)). The study lists 2 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 11 May 2025.