Affect, Depression, HIV Disease, Psychological Stress
Conditions
Brief summary
This is a feasibility/pilot test of a set of positive affect skills provided online to HIV positive people with elevated depressive symptoms - a Center for Epidemiological Studies Depression Scale D (CES-D) score \> 10. The investigators will test the feasibility of recruitment, retention and acceptability of these skills in an online delivery format, determine feasibility and acceptability of daily emotion assessments via text messaging and assess efficacy of these skills for improving psychological well-being this population.
Interventions
BEHAVIORALIntervention
Positive Affect Skills Training
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV + * 18 or older * Score of CES-D depression scale \>10 * Daily internet access * Smart phone ownership
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of ORCHID content | 5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content. | We will track participation in both the self-report questionnaires as well as the intervention sessions (e.g., number of ORCHID sessions completed, amount of home practice completed). We will carefully track usage - noting when participants who leave the study drop out to determine if there are particular sessions that are less acceptable than others. |
| Retention of participants in online delivery format. | 5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content. | We will track, for each participant who completes a screening questionnaire, where they heard about the study and the proportion who go on to enroll. We will track retention - noting when participants drop out to determine if particular sessions or activities result in less retention than other areas. |
| Feasibility of an online delivery format. | 5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content. | We will follow up with participants who have significant missing data to determine areas in which the protocol is feasible and to highlight areas for improvements. We will summarize participant feedback regarding the protocol and will use this feedback to inform the subsequent proposals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine acceptability of multiple daily emotion assessments using text messaging. | 5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content. | To measure this outcome, we will first document if anyone declines participation due to the perceived burden of the Ecological Momentary Assessment (EMA) protocol. We will carefully document adherence to the protocol and the proportion of assessments that participants complete. In the follow-up interviews, we will have questions specific to the EMA protocol to elicit feedback and suggestions for improvement |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assess preliminary efficacy of the ORCHID intervention for improving psychological well-being in people living with HIV who have elevated depressive symptoms. | 5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content. | To address Aim 3 (assess preliminary efficacy of ORCHID on psychological well-being), we will examine means on depression, positive and negative emotion, and perceived stress at each of the assessment points and compare the intervention and emotion reporting only control conditions. Given the small sample size, our analyses will be descriptive and exploratory. |
Countries
United States
Outcome results
None listed