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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01997008
First received: November 21, 2013
Last updated: December 2, 2013
Last verified: December 2013

November 21, 2013
December 2, 2013
December 2013
June 2014   (final data collection date for primary outcome measure)
  • 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. ] [ Designated as safety issue: No ]
    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. [ Time Frame: 5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content. ] [ Designated as safety issue: No ]
    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. [ Time Frame: 5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content. ] [ Designated as safety issue: No ]
    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.
Retention, feasibility and acceptability of ORCHID content and 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. ] [ Designated as safety issue: No ]
To address Aim 1 (demonstrate feasibility of recruitment and retention and acceptability of the intervention content and 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 adherence to both the self-report questionnaires as well as the online intervention sessions (e.g., number of ORCHID sessions completed, amount of home practice completed). 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. We will carefully track retention - noting when participants who leave the study drop out to determine if there are particular sessions that are problematic.
Complete list of historical versions of study NCT01997008 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
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
Determine feasibility and 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. ] [ Designated as safety issue: No ]
To address Aim 2 (determine feasibility and acceptability of multiple daily emotion assessments using text messaging), 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
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. ] [ Designated as safety issue: No ]
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.
Same as current
 
Optimizing Resilience and Coping in HIV Via Internet Delivery
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
  • HIV Disease
  • Depression
  • Affect
  • Psychological Stress
Behavioral: Intervention
Positive Affect Skills Training
  • 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.

    Intervention: Behavioral: Intervention
  • 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.

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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

-

Both
18 Years and older
No
Contact: Michael A Cohn, PhD cohnm@ocim.ucsf.edu
Contact: Judy Moskowitz, PhD moskj@ocim.ucsf.edu
United States
 
NCT01997008
UCSF CHR 13-11990
No
University of California, San Francisco
University of California, San Francisco
Not Provided
Not Provided
University of California, San Francisco
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP