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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 15, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
HIV Disease
Depression
Affect
Psychological Stress
Behavioral: Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Optimizing Resilience and Coping in HIV Via Internet Delivery

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: May 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997008

Contacts
Contact: Michael A Cohn, PhD cohnm@ocim.ucsf.edu
Contact: Judy Moskowitz, PhD moskj@ocim.ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Sub-Investigator: Michael A Cohn, PhD         
Principal Investigator: Judith Moskowitz, PhD         
Sponsors and Collaborators
University of California, San Francisco
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01997008     History of Changes
Other Study ID Numbers: UCSF CHR 13-11990
Study First Received: November 21, 2013
Last Updated: August 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 16, 2014