Optimizing Resilience and Coping in HIV Via Internet Delivery

NCT01997008 | Completed

• 1 other identifier: UCSF CHR 13-11990
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Disease; Depression; Affect; Psychological Stress

Outcome Measures

Primary Outcomes (3)

• 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.

  5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.

• 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.

  5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.

• 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.

  5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.

Secondary Outcomes (1)

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

  5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.

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.

  5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.

Study Arms (2)

Intervention

EXPERIMENTAL

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

Emotion reporting and EMA notification

NO INTERVENTION

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.

Interventions

Intervention BEHAVIORAL

Positive Affect Skills Training

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

• 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.

  PMID: 22021272 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Depression; Stress, Psychological

Interventions

Methods

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Judy Moskowitz, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: November 27, 2013
• Study Start: May 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 1, 2020

Record last verified: 2020-04

Locations

US (1)