Optimizing Resilience and Coping in HIV Via Internet Delivery

Depression Clinical Trial

— ORCHID  

Official title:

Optimizing Resilience and Coping in HIV Via Internet Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997008
• Other study ID #: UCSF CHR 13-11990
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: February 2015

Study information

• Verified date: April 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV +

• 18 or older

• Score of CES-D depression scale >10

• Daily internet access

• Smart phone ownership

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Affect
• Depression
• HIV Disease
• Psychological Stress
• Stress, Psychological

Intervention

Behavioral:
• Intervention
Positive Affect Skills Training

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (1)

Moskowitz JT, Hult JR, Duncan LG, Cohn MA, Maurer S, Bussolari C, Acree M. A positive affect intervention for people experiencing health-related stress: development and non-randomized pilot test. J Health Psychol. 2012 Jul;17(5):676-92. doi: 10.1177/1359105311425275. Epub 2011 Oct 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess preliminary efficacy of the ORCHID intervention for improving psychological well-being in people living with HIV who have elevated depressive symptoms.	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.	5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.
Primary	Acceptability of ORCHID 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.	5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.
Primary	Retention of participants in online delivery format.	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.	5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.
Primary	Feasibility of an online delivery format.	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.	5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.
Secondary	Determine acceptability of multiple daily emotion assessments using text messaging.	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	5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.