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| Name | Class |
|---|---|
| Southern Methodist University | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Affect Treatment | Experimental | 8 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Affect Treatment | Behavioral | Sessions 1-8: Pleasurable activities + imaginal recounting and reinforcement of positive mood effects |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| Southern Methodist University |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| Positive Affect Treatment and Negative Affect Treatment | Behavioral | 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 |
|
| 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 |
| 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 | 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 | 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 | 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 | Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition) |
| Dallas |
| Texas |
| 75205 |
| United States |