Optimizing Resilience and Coping in HIV Via Internet Delivery (ORCHID)

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.

Study Overview

• Status: Completed
• Conditions: Depression; Psychological Stress; HIV Disease; Affect
• Intervention / Treatment: Behavioral: Intervention

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• HIV +
• 18 or older
• Score of CES-D depression scale >10
• Daily internet access
• Smart phone ownership

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants receive a five week intervention providing the following activities: EMA: Ecological Momentary Assessment (EMA) of Emotion throughout the day. Intervention: Positive Events: Participants identify a positive event and then describe how they capitalized on this event. Gratitude: Participants identify one more more things that make them feel grateful. Mindfulness: Participants participate in a 30 minute guided mindfulness/meditation practice. Positive Reappraisal: Participants identify how they reappraised a negative event making it into a positive event. Personal Strengths: Participants identify one more more personal strengths. Attainable goals: Participants identify a short-term attainable goal. Participants will outline what they did that day to work toward attaining their week's goal. Acts of Kindness: Participants will identify one more more acts of kindness that they engaged in and how it made them feel.	Behavioral: Intervention; Positive Affect Skills Training
No Intervention: Emotion reporting and EMA notification; Participants report emotions and receive EMA (ecological momentary assessment) text messages on the same regular basis as intervention participants, but receive no interventions. EMA detail: Ecological Momentary Assessment (EMA) of Emotion throughout the day. We will assess current emotions via email or text message 4 times per day, 2 days per week (one randomly selected week/work day and one randomly selected weekend/non-work day) during the 8 week study period, for a total of 16 days of EMA reporting. Participants will be asked to rate how much they are currently feeling several positive and negative emotions that have been associated with mortality and health: happy, excited, content, appreciative, sad, worried, and fearful.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Judy Moskowitz, PhD, University of California, San Francisco

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: November 21, 2013
• First Submitted That Met QC Criteria: November 26, 2013
• First Posted (Estimate): November 27, 2013

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: UCSF CHR 13-11990