Depression and/or Anxiety in the Mild-to-moderate Range
Conditions
Brief summary
This is a two-site randomized controlled trial, with two goals. First, the investigators aim to demonstrate that single-session interventions for mild-to-moderate anxiety and depression can generate statistically significant symptom change as a main effect across control and experimental (i.e. personalized) conditions. Second, the investigators hope to establish the additional incremental efficacy of personalization via person-specific intensive longitudinal data collection and analysis.
Detailed description
This is a two-site randomized controlled trial, with two goals. First, the investigators aim to demonstrate that single-session interventions for mild-to-moderate anxiety and depression can generate statistically significant symptom change as a main effect across control and experimental (i.e. personalized) conditions. Second, the investigators hope to establish the additional incremental efficacy of personalization via person-specific intensive longitudinal data collection and analysis. All single-session interventions will be 90-minutes in length. At the conclusion of the intervention session, participants will receive suggestions for daily homework practice to complete and a flash drive with a copy of their session audio to review at their discretion. Participants will also meet with the therapist for a 10-minute remote check-in two weeks following the single session. All interventions include standard psychoeducational components. Participants randomized to the personalization arm of the study will be given an intervention matched to their most pressing psychosocial need. Participants randomized to the control condition will receive a standard intervention (at the UCB site) or a randomly selected one (at the BIU site). Both the standard intervention and the specific ones were designed to be broadly efficacious for depression and anxiety symptomatology. The psychosocial needs which serve as the focus of the interventions are derived from motivation and affect regulation models and include emotional stability, predictability, acceptance, competence, self-esteem, autonomy, and pleasure. The primary unmet need for each individual will be determined by a conditional entropy algorithm. Simply, the presence versus absence of subjective distress will be measured eight times per day for 30 days. Concurrently, the presence versus absence of need frustration will also be measured eight times per day for 30 days. Utilizing a k-fold cross-validated estimation, conditional entropy will be used to determine the need that best reduces the uncertainty in subjective distress (that is, best explains its presentation probabilistically).
Interventions
BEHAVIORALClinician-administered Need-focused Single Session Intervention
All single-session interventions will be 90-minutes in length. At the conclusion of the intervention session, participants will receive suggestions for daily homework practice to complete and a flash drive with a copy of their session audio to review at their discretion. They will also meet with the therapist for a 10-minute remote check-in two weeks following the single session. All interventions include standard psychoeducational components. Both the standard intervention and the specific ones were designed to be broadly efficacious for depression and anxiety symptomatology. The psychosocial needs which serve as the focus of the interventions are derived from motivation and affect regulation models.
Sponsors
University of California, Berkeley
United States - Israel Binational Science Foundation
Bar-Ilan University, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The participants and any care provider and study personnel who interact with them will be blind to condition. The PI will utilize a randomization table to allocate participants to condition, and will inform the front-line study personnel and through them, the care provider, regarding which intervention to use without specifying whether it was personalized or randomly-chosen. The outcomes assessor will be blind even to the type of intervention utilized.
Intervention model description
Randomized Control Trial with 2 conditions: Experimental condition (personalized-selected intervention) and control condition (randomly-selected or standard intervention focused on emotion-regulation).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criterion. \* a score of 5 or above on the Hamilton Rating Scale for Depression (HRSD).
Exclusion criteria
based on Diagnostic Interview for DSM-5 Anxiety, Mood, and Obsessive-Compulsive and Related Disorders (DIAMOND). * Psychotic Disorders (hallucinations or delusions) * Past or current mania, current hypo-mania. * Anorexia Disorder * Current Obsessive-Compulsive and related Disorders rated as moderate and above. * Alcohol or drug abuse rated as moderate and above. * Panic Disorder rated as moderate and above. * Agoraphobia rated as moderate and above. * Premenstrual dysphoric disorder rated as moderate and above. * Current Post-Traumatic Stress Disorder rated as moderate and above. * binge eating rated as moderate and above. * Phobia rated as severe and above. * Somatic symptom disorder rated as severe and above. * Illness Anxiety Disorder rated as severe and above. * MDD rated as severe and above. * GAD rated as severe and above. * Social Anxiety rated as severe and above. * Separation anxiety rated as severe and above.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton-Depression Rating Scale | Change between pre-intervention and 1 month post-intervention | (Range 0-52, higher scores denote greater depression) |
| Hamilton-Anxiety Rating Scale | Change between pre-intervention and 1 month post-intervention | (Range 0-56, higher scores denote greater anxiety); will be used in lieu of Hamilton-Depression ratings for individuals whose Hamilton-Anxiety scores are higher than their Hamilton-Depression scores. |
| Montgomery-Asberg Depression Rating Scale | Change between pre-intervention and 1 month post-intervention | (Range 0-60, higher scores denote greater depression) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PHQ-8 | Immediately prior to intervention, and again at 1 and 3 months post-intervention | (Range 0-24, higher scores denote greater depression) |
| GAD-7 | Immediately prior to intervention, and again at 1 and 3 months post-intervention | (Range 0-21, higher scores denote greater anxiety) |
| DASS | Immediately prior to intervention, and again at 1 and 3 months post-intervention | (Range 0-63, higher scores denote greater depression, anxiety, and stress) |
Other
| Measure | Time frame | Description |
|---|---|---|
| DERS-18 | Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention | Difficulties in Emotion Regulation |
| ERQ | Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention | Emotion Regulation Questionnaire |
| PSQI | Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention | Pittsburgh Sleep Quality Index |
| IIP-32 | Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention | Inventory of Interpersonal Problems |
| PANAS | Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention | Positive and negative affect schedule (20 items) |
Countries
Israel, United States
Contacts
Primary ContactEshkol Rafaeli, PhD
Backup ContactGal Lazarus, PhD
Outcome results
None listed