N/A
N=85
Treatment for Affect Dimensions
Depression · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT03439748 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P) — 20.76; 29.42; 24.18; 19.42 score on a scale — p=.002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Positive Affect Treatment (Behavioral); Negative Affect Treatment (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P) |
20.76; 29.42; 24.18; 19.42; 26.88; 22.57 | .002 sig |
| PRIMARY Interviewer Anhedonia Ratings |
7.66; 7.47; 6.11; 5.49; 4.91; 4.93 | >.05 |
| PRIMARY Depression Anxiety and Stress Scale (DASS-21) |
27.36; 24.51; 17.90; 17.92; 11.55; 13.00 | .024 sig |
| SECONDARY Sheehan Disability Scale (SDS) |
18.40; 16.65; 14.53; 14.84; 11.19; 11.86 | — |
| SECONDARY Beck Depression Inventory (BDI) |
0.17; 0.23; 0.18; 0.14; 0.18; 0.20 | — |
| SECONDARY Daily Activity/Social Interaction (Actigraph) |
40.212; 34.634; 41.98; 41.44; 34.21; 46.92 | — |
| SECONDARY Effort Expenditure for Rewards Task (EEfRT) |
0.41; 0.41; 0.43; 0.39; 0.51; 0.41 | .922 |
| SECONDARY Monetary Incentive Task |
-0.012; -0.017; 0.017; 0.013; -0.002; 0.004 | .049 sig |
| SECONDARY Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD) |
9.67; 9.42; 10.50; 10.14; 10.66; 10.66 | .591 |
| SECONDARY Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items |
42.85; 49.16; 52.28; 52.46; 55.63; 55.66 | .004 sig |
| SECONDARY Dimensional Anhedonia Rating Scale-Consummatory Items |
17.56; 19.12; 20.39; 20.51; 21.50; 21.59 | .030 sig |
| SECONDARY Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli |
-43.43; 2.80; 16.70; -16.49; -3.07; -31.56 | .029 sig |
| SECONDARY Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli |
9.30; 3.29; -17.65; 2.62; -20.86; -22.51 | — |
| SECONDARY International Affective Picture System Task |
0.0003; -0.0007; -0.0016; -0.0061; 0.0071; 0.0013 | .494 |
| SECONDARY Temporal Experience of Pleasure Scale (Consummatory Subscale) |
35.81; 37.12; 36.28; 37.49; 37.03; 37.97 | .231 |
| SECONDARY Probabilistic Reward Task (PRT) |
0.16; 0.15; 0.04; 0.19; 0.09; 0.03 | .344 |
| SECONDARY Pavlovian Instrumental Transfer Task - Force (PIT-FORCE) |
6.30; 4.91; 7.96; 6.72; 6.55; 6.57 | .267 |
| SECONDARY Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE) |
1.09; 0.62; 1.50; 0.73; 1.29; 0.44 | .051 |
Summary
The purpose of this study is to evaluate the efficacy and targets of Positive Affect Treatment, a psychotherapy specifically aimed at enhancing reward sensitivity in individuals with low positive affect (a core feature of anhedonia) in the context of depression or anxiety.
Target enrollment is 68 male and female participants with low positive affect and depression or anxiety and impaired functioning, between the ages of 18 and 65 years, who will be randomized to either Positive Affect Treatment or Negative Affect Treatment (designed to reduce 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 4 months.
Eligibility Criteria
Inclusion Criteria
- 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, greater to or equal to 6 for anxiety, or greater to or equal to 10 for stress on the Depression, Anxiety, and Stress Scale; and scores of greater than or equal to 5 on any Sheehan Disability Scale subscale.
- Willingness to refrain from starting other psychosocial or pharmacological treatments until study completion.
Exclusion Criteria
- 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)
- Active suicidal ideation
- Lifetime history of bipolar disorder, psychosis, mental retardation, or organic brain damage
- Substance abuse in the last 6 months or dependence within last 12 months.
- 11 or more 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)
- Pregnancy
- Bupropion, dopaminergic or neuroleptic medication 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
Data sourced from ClinicalTrials.gov (NCT03439748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.