Mindfulness and Acceptance Based Therapy for Adolescents Living With HIV

NCT05010317 | Completed

• 1 other identifier: D43TW011304
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 2

Brief Summary

Adolescents represent a growing share of people living with HIV in sub-Saharan Africa (SSA), yet show poor adherence to medication and viral suppression (VS) compared to adults. Investigators postulate that to achieve optimal adherence, support interventions that resonate with life-stages changes in adolescence need to be tested and promoted. Mindfulness and acceptance based interventions are slowly gaining traction as appropriate for adolescents. The study proposes to explore acceptability of an adapted mindfulness and acceptance-based psychosocial intervention (acceptance and commitment therapy: Discoverer, Noticer, Advisor-values model-ACT-DNA-v), among providers (health care practitioners -HCPs) and users (adolescents living with HIV/AIDS-ALWHA). Further, it endeavors to measure feasibility and effectiveness of ACT-DNA-v in reducing psychological barriers to adherence among ALWHAs. The study is to be conducted at two public health centers in Kampala-Uganda. The study design is exploratory sequential mixed-methods; where qualitative data is to be used to explore acceptance of ACT-DNA-v, while quantitative data will be used to measure feasibility of the intervention and its effectiveness in reducing psychosocial barriers to adherence. Qualitative exploratory methods will guide exploration of acceptability of ACT-DNA-v among users and providers; collecting data with a semi-structured interview on domains of inquiry including; understanding, satisfaction, intention to use and perceived appropriateness of ACT-DNA-v. A randomized control trial with quantitative surveys at baseline, post-intervention and follow-up will used to measure the effects of the intervention on process and clinical outcomes among ALWHA. Thematic data analysis will be used to analyze qualitative data, while T-test, Wilcoxon rank sum test, Fisher's exact and Chi-square tests respectively will be used to ascertain average mean differences between the ACT group and the control group on the outcome parameters.

Conditions

Medication Adherence; Adjustment Reaction With Anxiety and Depression; Mental Health Issue

Outcome Measures

Primary Outcomes (3)

• Change in levels of Depression; measured by Beck's Depression Inventory-ii

  The outcome measure will be; number of participants in a given study group reporting change from baseline depression levels at post intervention and after three months follow-up. The change will be assessed by Beck's depression inventory-ii. According to the BDI-ii, scores in the range of 0-13 represent minimal depression, 14-19 mild depression, 20-28 moderate, while 29-63 severe depression.

  pre-intervention and at four weeks post intervention assessment

• Change in Health related anxiety; measured by the short health anxiety inventory

  The outcome measure will be number of participants in a given study arm reporting change from baseline health anxiety at post intervention and at three months follow-up. According to the SHAI, 40.5 is the cut-off score separating clinical and non-clinical health related anxiety.

  At pre-intervention and at four weeks post intervention assessment

• Change in AIDS related Internalized stigma; measured by Internalized AIDS related stigma scale (IARSS-6)

  After dichotomizing the IARSS-6 at median value (0-2 \& 3-6), two categories will be created. Category 1 is in the 0-2 range (representing low-moderate stigma) while category 2 is the 3-6 range (representing higher experience of stigma). The measure will then be; the number of participants in a given study arm reporting change from baseline AIDS related stigma at post intervention and at three months follow-up as assessed by the internalized AIDS related stigma scale.

  At pre-intervention and at four weeks post intervention assessment

Secondary Outcomes (2)

• Self-reported medication adherence; measured by the Morisky Medication Adherence scale-MMAS-8.

  At three months

• Viral load

  At three months

Other Outcomes (1)

• Psychological flexibility; measured by the Avoidance and Fusion Questionnaire for youths (AFQ-Y8).

  At three months

Study Arms (2)

Group receiving the mindfulness and acceptance intervention

EXPERIMENTAL

This group will under go four sessions of the mindfulness and acceptance based therapy. These sessions will be delivered in four weeks, utilizing 2 hours every week. This will be in addition to the standard of care (clinic based counselling).

Behavioral: Mindfulness and acceptance based therapy; Behavioral: Standard of care

Control group

ACTIVE COMPARATOR

This group will continue receiving the usual clinic based care (counselling) only.

Behavioral: Standard of care

Interventions

Mindfulness and acceptance based therapy BEHAVIORAL

This is a behavioral intervention that is aimed at building psychological flexibility among adolescents. It involves careful use of language, metaphors, experiential learning and mindfulness to develop skills that support values guided living. Participants learn to relate with their inner thoughts, feelings and urges in an open and elaborative way as conscious human beings and make choices that improve their lives even in the presence of such difficult experiences.

Also known as: Acceptance and commitment therapy, Discoverer, Noticer, Advisor-Values

Group receiving the mindfulness and acceptance intervention

Standard of care BEHAVIORAL

Usual clinic based counselling offered as routine care to adolescents

Control group; Group receiving the mindfulness and acceptance intervention

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participant should be 15-19 years of age.
• Diagnosed HIV positive.
• Attending care at the two study sites (Kisenyi and Kitebi) for the last 6 months.
• On first or second line of treatment.
• Can speak/understand Luganda or English.
• Willing to provide informed consent/assent.
• All records will be confirmed via clinic medical charts.

You may not qualify if:

• A participant plan to move out of the catchment area within six months.
• Participant is participating in another study related to HIV and care improvement.

Sponsors & Collaborators

• Infectious Diseases Research Collaboration, Uganda: lead
• Makerere University: collaborator
• National Institutes of Health (NIH): collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (2)

Kisenyi Health center iv

Kampala, Central Region, +256, Uganda

Location

Kitebi health center iii

Kampala, Non-US/Non-Canadian, +256, Uganda

Location

Related Publications (10)

• Soomro N, Fitzgerald G, Seeley J, Schatz E, Nachega JB, Negin J. Comparison of Antiretroviral Therapy Adherence Among HIV-Infected Older Adults with Younger Adults in Africa: Systematic Review and Meta-analysis. AIDS Behav. 2019 Feb;23(2):445-458. doi: 10.1007/s10461-018-2196-0.

  PMID: 29971732 BACKGROUND

• Burckhardt R, Manicavasagar V, Batterham PJ, Hadzi-Pavlovic D, Shand F. Acceptance and commitment therapy universal prevention program for adolescents: a feasibility study. Child Adolesc Psychiatry Ment Health. 2017 May 25;11:27. doi: 10.1186/s13034-017-0164-5. eCollection 2017.

  PMID: 28559924 BACKGROUND

• Casale M, Carlqvist A, Cluver L. Recent Interventions to Improve Retention in HIV Care and Adherence to Antiretroviral Treatment Among Adolescents and Youth: A Systematic Review. AIDS Patient Care STDS. 2019 Jun;33(6):237-252. doi: 10.1089/apc.2018.0320.

  PMID: 31166783 BACKGROUND

• Vreeman RC, McCoy BM, Lee S. Mental health challenges among adolescents living with HIV. J Int AIDS Soc. 2017 May 16;20(Suppl 3):21497. doi: 10.7448/IAS.20.4.21497.

  PMID: 28530045 BACKGROUND

• Wang YP, Gorenstein C. Psychometric properties of the Beck Depression Inventory-II: a comprehensive review. Braz J Psychiatry. 2013 Oct-Dec;35(4):416-31. doi: 10.1590/1516-4446-2012-1048. Epub 2013 Dec 23.

  PMID: 24402217 BACKGROUND

• Kalichman SC, Simbayi LC, Cloete A, Mthembu PP, Mkhonta RN, Ginindza T. Measuring AIDS stigmas in people living with HIV/AIDS: the Internalized AIDS-Related Stigma Scale. AIDS Care. 2009 Jan;21(1):87-93. doi: 10.1080/09540120802032627.

  PMID: 19085224 BACKGROUND

• Moon SJ, Lee WY, Hwang JS, Hong YP, Morisky DE. Accuracy of a screening tool for medication adherence: A systematic review and meta-analysis of the Morisky Medication Adherence Scale-8. PLoS One. 2017 Nov 2;12(11):e0187139. doi: 10.1371/journal.pone.0187139. eCollection 2017.

  PMID: 29095870 BACKGROUND

• Greco LA, Lambert W, Baer RA. Psychological inflexibility in childhood and adolescence: development and evaluation of the Avoidance and Fusion Questionnaire for Youth. Psychol Assess. 2008 Jun;20(2):93-102. doi: 10.1037/1040-3590.20.2.93.

  PMID: 18557686 BACKGROUND

• Abramowitz JS, Deacon BJ, Valentiner DP. The Short Health Anxiety Inventory: Psychometric Properties and Construct Validity in a Non-clinical Sample. Cognit Ther Res. 2007;31(6):871-883. doi: 10.1007/s10608-006-9058-1. Epub 2007 Feb 15.

  PMID: 32214558 BACKGROUND

• Musanje K, Kasujja R, Camlin CS, Hooper N, Hope-Bell J, Sinclair DL, Kibanja GM, Mpirirwe R, Kalyango JN, Kamya MR. Effectiveness of a mindfulness and acceptance-based intervention for improving the mental health of adolescents with HIV in Uganda: An open-label trial. PLoS One. 2024 May 9;19(5):e0301988. doi: 10.1371/journal.pone.0301988. eCollection 2024.

  PMID: 38722926 DERIVED

Related Links

• UPHIA Uganda factsheet
• UNAIDS report on the global AIDS epidemic 2020

MeSH Terms

Conditions

Medication Adherence; Depression

Interventions

Mindfulness; Acceptance and Commitment Therapy; Standard of Care

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Moses R Kamya

  IDRC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This will be an open label randomized study because the staff will be involved in the care of the participants, assessment of the outcome and the nature of the psychosocial interventions to be administered.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group of adolescents (treatment group), will be exposed to a mindfulness and acceptance based psychotherapy on top of usual clinic care services, while the other group will keep receiving usual clinic care. Then comparison will be made at post intervention on experiences of depression, stigma, anxiety, psychological flexibility and then self-reported medical adherence at post intervention between the two groups, adjusting for baseline measures.

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 18, 2021
• Study Start: November 1, 2022
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available effective 1st June 2023. It will remain available for one year
• Access Criteria: through clinicaltrials.gov

Locations

UG (2)