The Effectiveness of Psychoeducation and Problem-solving (Life-steps) on Depression and Treatment Adherence in HIV Infected Adolescents: an Exploratory Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Botswana
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Depressive symptoms were measured with Patient Health Questionnaire (PHQ-9), has sensitivity and specificity of 0.8 and 0.7. The cut-off of nine or more was consistent with a diagnosis of depression
Study Overview
Brief Summary
Aim: To explore the effectiveness of psychoeducation and problem-solving (Life-steps) on depression and adherence in HIV-infected adolescents.
Methods: Forty-two adolescents were randomized into 21 controls and 21 intervention groups. The intervention group was exposed to 5-week sessions of life steps applied by a lay counselor. The PHQ-9 and visual analog scale (VAS) were used to measure the outcomes: depression and adherence. They were applied at baseline, 5-weeks, and 24 weeks post-intervention.
Detailed Description
General objectives
To explore the effect of psychoeducation and problem solving (LIFE STEPS) technique on medication adherence and depression among mentally ill ALWHIV in Botswana.
Specific Objectives
- To compare the sociodemographic and clinical variables of the ALWHIV: intervention and control group
- To explore the effect of psychoeducation and problem solving (LIFE STEPS) on medication adherence and depression among ALWHIV.
Methodology Study Design: Randomised controlled trial to assess the psychological intervention program.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 12 Years to 19 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •HIV infected adolescents aged, 12 - 19 years
- •On ART for a minimum of six months.
- •Speak or communicate in Setswana or English.
- •Outpatient
- •Willing to participate
Exclusion Criteria
- •Psychotic, and intellectually disabled patients
Outcomes
Primary Outcomes
Depressive symptoms were measured with Patient Health Questionnaire (PHQ-9), has sensitivity and specificity of 0.8 and 0.7. The cut-off of nine or more was consistent with a diagnosis of depression
Time Frame: 5 weeks
Change in PHQ-9 score or change in depressive symptoms score
Secondary Outcomes
- Medication adherence: measured with the Visual Analogue Scale (VAS), a horizontal line, 10cm long, and calibrated by 5 from 0 to 100. Score of <95% is suboptimal adherence based on 30 days pill use. It exhibits medium to large strength (r = 0.5-0.7).(5 weeks)