A Brief Intervention Targeting Anhedonia in Adolescents: a Feasibility Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Feasibility outcome - 1: Uptake by schools
研究概览
简要总结
Depression is a common mental health problem that often begins during adolescence. Onset during adolescence can be disruptive to schoolwork and social relationships and if left untreated can lead to recurrence during adulthood, as well as the development of other mental health problems. Current treatments for depression (for both adults and young people) largely focus on reducing low mood and do not effectively tackle the other hallmark symptom of depression, anhedonia, which is characterised as a loss of enjoyment/ pleasure for previously enjoyed activities. Anhedonia is associated with increased risk of suicidality, so should be an important treatment target. Whilst some adult treatments are beginning to address anhedonia, little research has focussed on young people. It cannot be assumed that adult treatments will work identically in young people, particularly s their brains are still maturing compared to adults. The aim of this study is to complete a randomised feasibility trial, to see if it is possible to run a brief talking therapy for anhedonia in adolescent depression, by targeting one promising cognitive factor known to contribute to low positive affect: positive future mental imagery
详细描述
The goal of the project is to develop a brief, manualised intervention for adolescent depression that targets anhedonia through harnessing the ability to imagine positive events. This intervention is designed to be delivered in the school environment by practitioners without extensive training. A feasibility randomised controlled trial (RCT) will be conducted by the doctoral student in the proposed project to assess the acceptability of this intervention in schools.
Principal Research Questions:
The primary question is whether a brief, structured intervention to reduce anhedonia symptomatology in depressed adolescents is feasible and acceptable. This trial will inform whether a full-scale efficacy trial is warranted and provide estimates of effect sizes. The trial's primary aims are:
- To evaluate recruitment and retention for a future efficacy RCT, for example recruitment rates for schools and participants, attrition rates and outcome measure completion.
- To gather descriptive data on symptom change to inform future estimates of the number of participants required for a fully powered efficacy RCT.
Background:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Willing and able to engage in psychological therapy and complete assessments
- •scoring above clinical cut-off on the MFQ (33 items; clinical cut-off ≥20, and showing high symptoms of anhedonia, as measured by the SHAPS ( 14 items; abnormal level of hedonic tone>2).
排除标准
- •Diagnosis of learning disability (but not difficulty e.g. dyslexia), diagnosis of Autism Spectrum Disorder, or significant head injury, neurological disorder or epilepsy
- •Unable to fluently communicate in spoken English
- •Unable to give informed consent
- •High levels of current risk
- •Currently receiving therapy (including school counselling)
- •Experiencing psychotic symptoms or depressed in the postnatal period (participants with co-morbid physical illness or non-psychotic disorders such as anxiety will not be excluded)
研究组 & 干预措施
Intervention: IMAGINE-P
Experimental intervention: IMAGINE-POSITIVE targeting positive affect (IMAGINE-P):
The intervention will combine aspects of Memory Specificity Training (MeST), which includes information about the links between memories and emotions, with Positive Prospective Mental Imagery (PPMI).
干预措施: IMAGINE-POSITIVE (Behavioral)
Control:
Control intervention: Non-directive supportive therapy (NDST) consists of individual sessions, with an empathetic, emotionally supportive practitioner and provides non-directive problem solving and monitoring. Using NDST will control for factors that may contribute to change, which are not active components e.g. speaking to an empathetic therapist. NDST will follow treatment guidelines.
干预措施: Control (Behavioral)
结局指标
主要结局
Feasibility outcome - 1: Uptake by schools
时间窗: Through study completion, an average of 9 months
A percentage will be calculated for: the number of schools that express interest in the study divided the number of schools that do take part.
Feasibility outcome - 2: Uptake by participants
时间窗: Through study completion, an average of 9 months
This will outcome will be assessed at the different stages of participant uptake: 1. the number of participants that completed the screen questionnaire divided by the number of students who received the screen questionnaire 2. the number of participants that accepted the invitation to pre-assessment divided by the number of participants that were eligible for pre-assessment from the screen 3. The number of participants randomised to intervention divided by the number of participants that completed the pre-assessment 4. The number of participants that completed the post-assessment divided by the number of participants that were randomised to intervention
Feasibility outcome - 3: Intervention completion
时间窗: Through study completion, an average of 9 months
The number of participants successfully completing the intervention
Feasibility outcome - 4: Intervention drop-out
时间窗: Through study completion, an average of 9 months
The number of participants that drop-out and the reasons for dropping out
Feasibility outcome - 5: Time Period
时间窗: Through study completion, an average of 9 months
Time needed to collect and analyse data
Feasibility outcome - 6: Data completeness at pre-assessment
时间窗: Through study completion, an average of 9 months
Data completeness for each questionnaire at pre-assessment
Feasibility outcome - 7: Missing Data at pre-assessment
时间窗: Through study completion, an average of 9 months
Data missing and reasons for missing data at pre-assessment
Feasibility outcome - 8: Data completeness at post-assessment
时间窗: Through study completion, an average of 9 months
Data completeness for each questionnaire at post-assessment
Feasibility outcome - 9: Missing Data at post-assessment
时间窗: Through study completion, an average of 9 months
Data missing and reasons for missing data at post-assessment
Feasibility outcome - 10: Data completeness at follow-up assessment
时间窗: Through study completion, an average of 9 months
Data completeness for each questionnaire at follow-up assessment
Feasibility outcome - 11: Missing Data at follow-up assessment
时间窗: Through study completion, an average of 9 months
Data missing and reasons for missing data at follow-up assessment
Feasibility outcome - 12: Unexpected adverse effects
时间窗: Through study completion, an average of 9 months
The number and nature of unexpected adverse effects will be recorded
Acceptability of the intervention - 1: Open questions for qualitative feedback of the programme
时间窗: Post-intervention (within 2 weeks of post intervention)
Qualitative questions on the feedback questionnaire: 1. What did you think of the programme? 2. Was there anything that made you more likely or less likely to take part in the programme? 3. How did you find completing the programme at school? 4. Was there anything about the programme that you really liked? 5. Was there anything about the training programme that you really didn't like? 6. What was the most important thing about the programme for you? 7. Would you recommend this to others who are experiencing difficulties with mood and self-esteem? If so why? Or why not? 8. Is there anything else you'd like to say about this programme?
Acceptability of the intervention - 2: Satisfaction with the programme
时间窗: Post-intervention (within 2 weeks of post intervention)
Participants indicate how satisfied they were with the programme on a 5-point scale; minimum score: 1; maximum score 5. Higher scores indicate better outcome.
Acceptability of the intervention - 3: Feedback on the number of sessions in the programme
时间窗: Post-intervention (within 2 weeks of post intervention)
Participants rate what they thought about the number of session on a 5-point scale. 1 = I would have liked 2+ less; 2= I would have liked 1-2 less; 3= I was happy with the number of sessions; 4= I would have liked 1-2 more; 5= I would have liked 2+ more. Minimum score: 1; maximum score 5.
Acceptability of the intervention - 4: Extend the programme has helped
时间窗: Post-intervention (within 2 weeks of post intervention)
Participants rate the extent to which the programme helped them on a 5-point scale. Minimum score: 1; maximum score: 5; higher scores indicate better outcome.
Acceptability of the intervention - 5: Recommend the programme to a friend
时间窗: Post-intervention (within 2 weeks of post intervention)
Participants rate if they would recommend the programme to a friend on a 5-point scale. 1= no, definitely not; 2= probably not; 3 = unsure; 4 = yes, probably; 5 = yes, definitely. Minimum score: 1; maximum score 5; higher scores indicate better outcome.
次要结局
- Mood and Feelings Questionnaire(Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up)
- Snaith-Hamilton Pleasure Scale(Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up)
- Positive and Negative Affect Schedule(Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up)
- The Prospective Imagery Task(Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up)
- Autobiographical Memory Task(Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up)
- Screen for Child Anxiety Related Disorders(Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up)
- Rosenberg Self Esteem Scale(Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up)
- Children's Response Style Questionnaire(Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up)
- Self Compassion Scale(Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up)
- Child Revised Impact of Event Scale(Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up)