Self-affirmation Plus Positive Living CounselingNCT03762187
A Brief Affirmation Intervention on HIV-related Distress and Positive Living in Lesotho
A study testing Self-affirmation and Positive living counseling in people with Self-affirmation Plus Positive Living Counseling and Counseling, run by University of California, Santa Barbara.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Self-affirmation Plus Positive Living Counseling, Counseling
- What is being tested?
- Self-affirmation and Positive living counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 389 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 31 Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV+
- 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
Who cannot join
- -
About this study
Official title: Effects of a Brief Affirmation Intervention on HIV-related Distress and Positive Living Intentions Among Individuals Recently Diagnosed With HIV in Lesotho
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.
- Being tested
- Self-affirmation, Positive living counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-affirmationBehavioural
Individuals select important values and then write about why that value is important to them.
Positive living counselingBehavioural
Each of the clinics from which participants were recruited conducts positive living counseling as part of their treatment programs. This counseling is conducted by counselors who are trained and monitored by the Lesotho Network of AIDS Support Organizations (LENASO) and consistent with the positive prevention framework (see Bunnell et al., 2005 for description). Each counseling session focused on addressing positive living goals such as the importance of taking one's medications on time and every day, using protection with every partner, and the importance of maintaining a healthy lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| Self-affirmation | Experimental | Participants completed a written self-affirmation manipulation before completing the standard counseling provided by the clinic. Receives: Behavioral: Self-affirmation; Behavioral: Positive living counseling |
| Positive living counseling | Active comparator | Participants completed the standard counseling provided by the clinic (treatment as usual control condition). Receives: Behavioral: Positive living counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
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".
Measured: Post-intervention survey conducted immediately after intervention session
Intrusion subscale of impact of events scale
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.
Measured: Post-intervention survey conducted immediately after intervention session
Concerns about dying
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.
Measured: Post-intervention survey conducted immediately after intervention session
Distressing emotions related to HIV
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.
Measured: Post-intervention survey conducted immediately after intervention session
Future behavioral intentions
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".
Measured: Post-intervention survey conducted immediately after intervention session
Secondary outcomes (1)
Physical health measures
In order to assess participants' baseline self-reported health, participants completed the general health subscale of the RAND 36-item Short Form Health Survey, a well-validated measure designed to assess health that is utilized by many health organizations, including Medicare, to assess and monitor healthcare outcomes. Participants were asked to answer five questions regarding their current health using a 5-point Likert scale.
Measured: Post-intervention survey conducted immediately after intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start1 Sep 2014
- Primary completion31 Jan 2015
- Study completion31 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-affirmation Plus Positive Living CounselingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Participants are randomized to one of the two conditions.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Santa Barbara
- Sponsor type
- University, hospital or other
- Collaborators
- Fulbright, Ministry of Health, Lesotho
- Responsible party
- Principal investigator, David Sherman, University of California, Santa Barbara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762187
- Sponsor's protocol ID
- 13-0333
- Status last verified
- Dec 2023
- First submitted
- 1 Nov 2018
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Brief Affirmation Intervention on HIV-related Distress and Positive Living Intentions Among Individuals Recently Diagnosed With HIV in Lesotho
- ClinicalTrials.gov ID
- NCT03762187
- Acronym / sponsor ID
- 13-0333
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- University of California, Santa BarbaraUniversity, hospital or other
- Collaborators
- Fulbright, Ministry of Health, Lesotho
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 31 Jan 2015 (actual)
- Study completion
- 31 Jan 2015 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants are randomized to one of the two conditions.
| Arm | Type | Receives |
|---|---|---|
| Self-affirmation | Experimental | Behavioral: Self-affirmation, Behavioral: Positive living counselingParticipants completed a written self-affirmation manipulation before completing the standard counseling provided by the clinic. |
| Positive living counseling | Active comparator | Behavioral: Positive living counselingParticipants completed the standard counseling provided by the clinic (treatment as usual control condition). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- HIV+
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-affirmationIndividuals select important values and then write about why that value is important to them. | Behavioural | Self-affirmation |
| Positive living counselingEach of the clinics from which participants were recruited conducts positive living counseling as part of their treatment programs. This counseling is conducted by counselors who are trained and monitored by the Lesotho Network of AIDS Support Organizations (LENASO) and consistent with the positive prevention framework (see Bunnell et al., 2005 for description). Each counseling session focused on addressing positive living goals such as the importance of taking one's medications on time and every day, using protection with every partner, and the importance of maintaining a healthy lifestyle. | Behavioural | Positive living counseling, Self-affirmation |
Primary outcome
Perceived Stress Scale
Time frame: 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".
Intrusion subscale of impact of events scale
Time frame: 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.
Concerns about dying
Time frame: 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.
Distressing emotions related to HIV
Time frame: 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
Time frame: 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".
1 secondary outcome
Physical health measures
Time frame: Post-intervention survey conducted immediately after intervention session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Self-affirmation and Positive living counseling in people with Self-affirmation Plus Positive Living Counseling and Counseling, run by University of California, Santa Barbara.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (time frame: Post-intervention survey conducted immediately after intervention session). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.