Back to resultsOptimizing Resilience and Coping in HIV Via Internet Delivery (ORCHID)
Primary Purpose
HIV Disease, Depression, Affect
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for HIV Disease
Eligibility Criteria
Inclusion Criteria:
- HIV +
- 18 or older
- Score of CES-D depression scale >10
- Daily internet access
- Smart phone ownership
Exclusion Criteria:
-
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Emotion reporting and EMA notification
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01997008
First Posted
November 21, 2013
Last Updated
April 30, 2020
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01997008
Brief Title
Optimizing Resilience and Coping in HIV Via Internet Delivery
Acronym
ORCHID
Official Title
Optimizing Resilience and Coping in HIV Via Internet Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Disease, Depression, Affect, Psychological Stress
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Emotion reporting and EMA notification
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
Positive Affect Skills Training
Primary Outcome Measure Information:
Title
Acceptability of ORCHID content
Description
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.
Time Frame
5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.
Title
Retention of participants in online delivery format.
Description
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.
Time Frame
5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.
Title
Feasibility of an online delivery format.
Description
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.
Time Frame
5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.
Secondary Outcome Measure Information:
Title
Determine acceptability of multiple daily emotion assessments using text messaging.
Description
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
Time Frame
5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.
Other Pre-specified Outcome Measures:
Title
Assess preliminary efficacy of the ORCHID intervention for improving psychological well-being in people living with HIV who have elevated depressive symptoms.
Description
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.
Time Frame
5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV +
18 or older
Score of CES-D depression scale >10
Daily internet access
Smart phone ownership
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy Moskowitz, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22021272
Citation
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.
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Optimizing Resilience and Coping in HIV Via Internet Delivery
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