School-based IPT-G for Adolescents With Depression in Nepal: a Pilot Realist C-RCT

NCT06017700 | Unknown DMC

• 1 other identifier: MR/W00285X/1
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

Globally a third of adolescents are at risk of depression with negative consequences for their health and development. Most of the world's adolescents live in low- and middle-income countries (LMICs) where access to treatment for depression is limited. Psychological interventions are treatments that seek to change behaviours, cognitions and feelings to improve mental health but few have been tested with adolescents in LMICs. This study will use a cluster randomised controlled trial approach to test one such intervention, interpersonal therapy (IPT) for adolescents in Chitwan district, Nepal. The current study will compare whether adolescents (aged 13-18) with depression who receive group interpersonal therapy improve more than adolescents who receive information about local mental health services but no active intervention (enhanced usual care). Adolescents' depressive symptoms will be assessed eight to ten weeks after IPT has finished using the Patient Health Questionnaire modified for adolescents (PHQ-A). We will also aim to assess the feasibility and acceptability of delivering group IPT in secondary schools in Chitwan, Nepal. In addition, in this trial we aim to refine our hypotheses around why IPT works, how, and for whom, and pilot the tools which will be used to answer these questions later in the full trial.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Depression

  Patient Health Questionnaire for Adolescents (PHQ-A) will be used to measure depression. PHQ-A is a 9-item scale. It has a 4-point rating scale where 0 indicates 'not at all' and 3 indicates 'always'. The minimum scale score is 0 and the maximum is 27 with high score indicating severity of anxiety.

  Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)

Secondary Outcomes (4)

• Anxiety

  Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)

• Functional Impairment

  Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)

• School Attendance

  Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)

• PTSD

  Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)

Study Arms (2)

IPT-G

EXPERIMENTAL

Participants in the intervention arm will receive group interpersonal therapy in schools facilitated by trained laypersons. Groups are gender specific and comprise 6-8 adolescents. There are ten group sessions (approximately 90 min each, delivered weekly): in the first session the facilitator will focus on encouraging participants to review and share their interpersonal problems and instilling hope for recovery. In the middle sessions (2-9) participants will learn and practice interpersonal skills and offer and receive support from group members to resolve their problems. In the last session, they will review and celebrate progress and make plans to tackle future problems.

Behavioral: Interpersonal Psychotherapy Group

Enhanced Usual Care

ACTIVE COMPARATOR

Participants in the control arm will receive enhanced usual care. In intervention and control arms we will train health workers in health posts and primary care centres using the WHO mental health GAP Action training package. Participants in the control clusters will receive a handout with information about the location of these trained health workers and how they can access treatment. Participants in the control cluster reporting a current suicide plan or a suicide attempt in the past three months at baseline or in subsequent surveys will be assessed by a psychosocial counsellor employed through the project and offered one to one counselling as needed.

Behavioral: Enhanced Usual Care

Interventions

Interpersonal Psychotherapy Group BEHAVIORAL

IPT is a psychological intervention that focuses on four common problems that trigger depression: grief, disputes, role transitions and social isolation. Using techniques and strategies such as linking mood to event and event to mood, role play and skill-building, IPT encourages the individual to analyse and improve their interpersonal relationships context. IPT was developed in the USA to treat depressed adults but it has also been used to treat other mental disorders and among different age groups.

IPT-G

Enhanced Usual Care BEHAVIORAL

Participants attending schools in the control arm will receive enhanced usual care. In intervention and control arms, we will train health workers in health posts and primary care centres using the WHO mental health GAP Action training package (mhGAP). Participants in the control clusters will receive a handout with information about the location of these trained health workers and how they can access treatment. Adolescents in the control cluster reporting a current suicide plan (i.e. in the past 2 weeks) or suicide attempt in the past three months will be assessed by a psychosocial counsellor employed through the project and offered counselling or referral to other services as per need.

Enhanced Usual Care

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Attending a participating school
• Enrolled in Class 8, 9 or 11
• Depressed (i.e. scoring 10 or more on the PHQ-A)
• Functionally impaired (i.e. scoring 4 or more on the functional impairment tool)

You may not qualify if:

• In Class 10 and 12 because these students will be busy preparing for School Education and Plus 2 exams
• In Class 7 because they may be too young to benefit from IPT
• Current suicide plan or attempted suicide in the past three months because these adolescents require more acute, intensive treatment
• Conversion disorder ("chhopne") in the past three months because group-based treatments may not be appropriate

Sponsors & Collaborators

• Transcultural Psychosocial Organization Nepal: lead
• King's College London: collaborator

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Kamal Gautam, MD

  Transcultural Psychosocial Organization Nepal

  STUDY DIRECTOR

Central Study Contacts

Nagendra Luitel, PhD

CONTACT

9841333725; luitelnp@gmail.com

Kelly Clarke, PhD

CONTACT

kelly.rose-clarke@kcl.ac.uk

Study Design

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

Model Details: The study design is a parallel two-arm realist pilot cluster-randomised controlled trial. The trial will be conducted in eight schools (four intervention and four control). We will assess participants in intervention and control arms at baseline (week 0), after the first group session (week 5), after the sixth group session (week 12), at endline (weeks 20-21) and at follow-up (weeks 45-46). A caregiver survey will be administered at baseline and endline. Focus groups and interviews will be conducted with patients, caregivers, teachers, nurses, school principals.

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 30, 2023
• Study Start: September 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: The data is expected to be available when the data collection is complete. The expected date is June 2023.
• Access Criteria: Individuals need to email Dr. Kelly Rose-Clarke (kelly.rose-clarke@kcl.ac.uk) with an intent statement explaining the purpose of the request