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临床试验/NCT03762187
NCT03762187已完成不适用

Effects of a Brief Affirmation Intervention on HIV-related Distress and Positive Living Intentions Among Individuals Recently Diagnosed With HIV in Lesotho

University of California, Santa Barbara0 个研究点目标入组 389 人开始时间: 2014年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
389
主要终点
Concerns about dying

研究概览

简要总结

This study is interested in the stress associated with being HIV positive and looking at ways to reduce that stress. Individuals who are HIV positive face a number of nontrivial threats and stressors: the burden of illness, loss of work, stigmatization, and the chance of death. The study investigates the use of self-affirmation to reduce some of these threats and stressors. Self-affirmation may helping people to cope with these threats and stressors by reminding individuals of other valued aspects of themselves, thus reducing the impact, both psychologically and physiologically, of these threats. Experimentally induced affirmations in which individuals are asked to write about values that are important to the self have been shown to reduce physiological stress among healthy student populations (Sherman, Bunyan, Creswell, & Jaremka, 2009).

This research will be conducted in collaboration with the global health organizations, PSI who is already providing counseling to those living with HIV on how to reduce the spread of HIV and how to live a healthy life with HIV. These counseling sessions take place at local clinics and hospitals while individuals are waiting to be seen for treatment and are completely voluntary.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

Neither patients nor counselors were aware of participants' assigned condition

入排标准

性别
All
接受健康志愿者

入选标准

  • A CD4 count of less than or equal to 500 cells/mm3 or have significant symptomatology and HIV co-illness (WHO HIV clinical stage 3 or 4) to be eligible to start antiretroviral therapy

排除标准

  • 未提供

研究组 & 干预措施

Positive living counseling

Active Comparator

Participants completed the standard counseling provided by the clinic (treatment as usual control condition).

干预措施: Positive living counseling (Behavioral)

Self-affirmation

Experimental

Participants completed a written self-affirmation manipulation before completing the standard counseling provided by the clinic.

干预措施: Positive living counseling (Behavioral)

Self-affirmation

Experimental

Participants completed a written self-affirmation manipulation before completing the standard counseling provided by the clinic.

干预措施: Self-affirmation (Behavioral)

结局指标

主要结局

Concerns about dying

时间窗: Post-intervention survey conducted immediately after intervention session

Participants indicated to what extent they were currently concerned about dying using a single item, "Today, I find myself worrying about dying". Participants indicated their agreement with that statement using a 6-point Likert scale from 1= "Very Much Disagree" to 6 = "Very Much Agree", with higher numbers indicating greater worries about dying.

Intrusion subscale of impact of events scale

时间窗: Post-intervention survey conducted immediately after intervention session

Participants completed questions regarding their current experience of intrusive thoughts related to HIV adapted from the intrusion subscale of the Impact of Events Scale (Horowitz, Wilner, \& Alvarez, 1979). This measure was designed to assess distress caused by traumatic events. The impact of events scale is a well-validated measure that is often used (in combination with the DSM-IV) to assess post-traumatic stress disorder. In essence, this measure was designed to assess how traumatized participants felt by their HIV diagnosis. Participants rated their agreement with statements such as "Today, any reminder of HIV brings back feelings about it" and "Today, I think about HIV even when I don't mean to" using a 1= "Very Much Disagree" to 6 = "Very Much Agree" scale.

Perceived Stress Scale

时间窗: Post-intervention survey conducted immediately after intervention session

Participants were asked to complete an abbreviated version of the Perceived Stress Scale (Cohen, Kamarck, \& Mermelstein, 1983), a well validated measure of participants' current stress. For this scale, participants are asked to rate their agreement with statements such as "Today, I feel nervous and stressed" or "Today I feel that difficulties are piling up so high that I cannot overcome them" using a 6-point Likert scale anchored from 1= "Very Much Disagree" to 6 = "Very Much Agree".

Distressing emotions related to HIV

时间窗: Post-intervention survey conducted immediately after intervention session

Participants indicated to what extent they were experiencing distressing emotions related to HIV on a 5-point Likert scale from 1="Never" to 5="Always", with higher numbers indicating a greater frequency of distressing emotions related to HIV.

Future behavioral intentions

时间窗: Post-intervention survey conducted immediately after intervention session

Participants were asked to rate their agreement with statements regarding their future intentions to engage in positive living behaviors using a 6-point Likert scale from from 1= "Very Much Disagree" to 6 = "Very Much Agree". In particular, participants were asked to indicate their intention to use condoms in the future by indicating their agreement with statements such as, "If a sexual partner didn't want to use condoms, we would have sex without using condoms" or "It is a hassle to use condoms". Participants indicated their intention to take their medications by indicating their agreement with the statements, "I will take my medication regularly" and "I have trouble taking my medication as I am supposed to (reversed)". Additionally, participants indicated their intention to have non-concurrent sexual partners using the statement "I will only have one sexual relationship at a time".

次要结局

  • Physical health measures(Post-intervention survey conducted immediately after intervention session)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Sherman

Professor

University of California, Santa Barbara

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