Optimizing Resilience and Coping in HIV Via Internet Delivery (ORCHID)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01997008|
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : March 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|HIV Disease Depression Affect Psychological Stress||Behavioral: Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Optimizing Resilience and Coping in HIV Via Internet Delivery|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Participants receive a five week intervention providing the following activities:
Ecological Momentary Assessment (EMA) of Emotion throughout the day.
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.
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.
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.
- 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.
- 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.
- 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.
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997008
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|