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OpenTrials
Completed

NCT Number: NCT01997008

Optimizing Resilience and Coping in HIV Via Internet Delivery

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Intervention

Behavioral

Positive Affect Skills Training

Primary outcomes

  1. Acceptability of ORCHID content

    Time frame: 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.

  2. Retention of participants in online delivery format.

    Time frame: 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.

  3. Feasibility of an online delivery format.

    Time frame: 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 outcomes

  1. Determine acceptability of multiple daily emotion assessments using text messaging.

    Time frame: 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 outcomes

  1. Assess preliminary efficacy of the ORCHID intervention for improving psychological well-being in people living with HIV who have elevated depressive symptoms.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: ORCHID

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 27, 2013
Registry last updated
May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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