Clinical trial NCT05507385: Imagine a Brighter Future: An Intervention to Improve Positive Emotions in Young People
Official title: A Brief Intervention Targeting Anhedonia in Adolescents: a Feasibility Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression
Anhedonia
Keywords: Adolescence
Depression
Anhedonia
Mental Imagery
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Mental Health Research UK
First posted: 2022-08-19
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants will be randomised to an intervention group or the control group.
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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:

1. To evaluate recruitment and retention for a future efficacy RCT, for example recruitment rates for schools and participants, attrition rates and outcome measure completion.
2. To gather descriptive data on symptom change to inform future estimates of the number of participants required for a fully powered efficacy RCT.

Background:

Depression is a major public health concern, associated with severe and long-lasting impairment. Many cases of depression start in adolescence with adolescent-onsets associated with greater illness burden than adult-onsets. Whilst psychological intervention in adolescence may prevent the persistence of depression into adulthood and its debilitating consequences, these are rarely available. There is also a consistent failure to produce well-replicated efficacious psychological and pharmacological treatments in adolescent depression. In adults, treatment innovation techniques have tried to focus on specific features, such as anhedonia, that are associated with severity and treatment response. Anhedonia, a loss of pleasure or lack of reactivity to pleasurable stimuli, is a hallmark feature of depression. It is associated with brain reward systems and, in youth, predicts illness severity, suicidality and poor treatment response better than other symptoms of depression. Given these findings and that brain reward systems underlying anhedonia are maturing and stabilising in adolescence focussing on the up-regulation of positive emotion during this developmental juncture could be a beneficial therapeutic approach.

Traditionally, psychological interventions for depression target negative affect in the present and/or past. However, potential deficits in processing positive information, in particular positive future-directed cognitions, may be crucial to alleviate anhedonia and produce enhanced treatment response. Mental imagery is suggested to be a powerful tool to promote changes in positive prospective cognitions. In adolescence, this approach could be particularly beneficial as it is a period when future orientation increases and when individuals rely more on imagery for processing and skill acquisition than in adulthood. Although research in this area in adolescent depression is limited, our findings suggest that having more vivid positive future imagery can protect against depressive symptoms in youth following a recent negative life event. Through a National Institute for Health and Care Research (NIHR) funded project, the investigators have developed a novel brief therapy manual and implementation protocol for adolescents using co-design methodology (Research Ethics Sub-Committee ref: HR-15/16-3548; Project ID: 14884). This targets mental imagery in general (rather than positive future mental imagery, in particular) to attenuate depression symptoms. A case series of 9 participants suggests that this intervention is acceptable and may have clinical utility. However, this intervention targets depression generally rather than anhedonia specifically and has only been delivered by an experienced child clinical psychologist. Therefore, the aim of this project is to develop a brief, manualised intervention that targets anhedonia in adolescents with depression, which can be delivered in schools by practitioners without extensive training.

Intervention:

The investigators will adapt our existing therapy manual to create a manualised protocol that more specifically targets positive future imagery to reduce anhedonia. The existing intervention is a four-session programme involving memory specificity training to increase specificity and access to autobiographical memories, imagery re-scripting to reduce distress from negative images and building of positive images. In order to tackle anhedonia more specifically, the investigators will replace negative imagery re-scripting with elements that target up-regulation of positive emotion and expand and elaborate on positive future imagery generation. These changes will also be informed through discussion with other experts and service-user consultants.

Feasibility randomised controlled trial: As this study will assess feasibility and not efficacy, a power calculation to determine sample size is not appropriate. The sample size (n=32, 16 in each arm) was determined with reference to good practice recommendations. The control condition will be 'non-directive supportive therapy', consisting of individual sessions to provide empathy and emotional support, discussion of participant-initiated options for addressing problems and monitoring of depression. The number and frequency of sessions will be matched across groups to control for non-specific factors contributing to change (e.g. passage of time, rapport with an empathic adult). Blind pre/post assessments will be conducted for all participants.

Eligibility criteria: Inclusion Criteria:

1. Aged 14-19
2. Informed consent
3. Willing and able to engage in psychological therapy and complete assessments
4. 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).

Exclusion Criteria:

1. Diagnosis of learning disability (but not difficulty e.g. dyslexia), diagnosis of Autism Spectrum Disorder, or significant head injury, neurological disorder or epilepsy
2. Unable to fluently communicate in spoken English
3. Unable to give informed consent
4. High levels of current risk
5. Currently receiving therapy (including school counselling)
6. 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)

Primary outcomes:
measure: Feasibility outcome - 1: Uptake by schools
timeFrame: Through study completion, an average of 9 months
measure: Feasibility outcome - 2: Uptake by participants
timeFrame: Through study completion, an average of 9 months
measure: Feasibility outcome - 3: Intervention completion
timeFrame: Through study completion, an average of 9 months
measure: Feasibility outcome - 4: Intervention drop-out
timeFrame: Through study completion, an average of 9 months
measure: Feasibility outcome - 5: Time Period
timeFrame: Through study completion, an average of 9 months
measure: Feasibility outcome - 6: Data completeness at pre-assessment
timeFrame: Through study completion, an average of 9 months
measure: Feasibility outcome - 7: Missing Data at pre-assessment
timeFrame: Through study completion, an average of 9 months
measure: Feasibility outcome - 8: Data completeness at post-assessment
timeFrame: Through study completion, an average of 9 months
measure: Feasibility outcome - 9: Missing Data at post-assessment
timeFrame: Through study completion, an average of 9 months
measure: Feasibility outcome - 10: Data completeness at follow-up assessment
timeFrame: Through study completion, an average of 9 months
measure: Feasibility outcome - 11: Missing Data at follow-up assessment
timeFrame: Through study completion, an average of 9 months
measure: Feasibility outcome - 12: Unexpected adverse effects
timeFrame: Through study completion, an average of 9 months
measure: Acceptability of the intervention - 1: Open questions for qualitative feedback of the programme
timeFrame: Post-intervention (within 2 weeks of post intervention)
measure: Acceptability of the intervention - 2: Satisfaction with the programme
timeFrame: Post-intervention (within 2 weeks of post intervention)
measure: Acceptability of the intervention - 3: Feedback on the number of sessions in the programme
timeFrame: Post-intervention (within 2 weeks of post intervention)
measure: Acceptability of the intervention - 4: Extend the programme has helped
timeFrame: Post-intervention (within 2 weeks of post intervention)
measure: Acceptability of the intervention - 5: Recommend the programme to a friend
timeFrame: Post-intervention (within 2 weeks of post intervention)
Secondary outcomes:
measure: Mood and Feelings Questionnaire
timeFrame: Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up
measure: Snaith-Hamilton Pleasure Scale
timeFrame: Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up
measure: Positive and Negative Affect Schedule
timeFrame: Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up
measure: The Prospective Imagery Task
timeFrame: Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up
measure: Autobiographical Memory Task
timeFrame: Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up
measure: Screen for Child Anxiety Related Disorders
timeFrame: Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up
measure: Rosenberg Self Esteem Scale
timeFrame: Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up
measure: Children's Response Style Questionnaire
timeFrame: Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up
measure: Self Compassion Scale
timeFrame: Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up
measure: Child Revised Impact of Event Scale
timeFrame: Pre-intervention (baseline), post-intervention (within 2 weeks of post intervention), 3 month follow up
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
References:
citation: Zisook S, Lesser I, Stewart JW, Wisniewski SR, Balasubramani GK, Fava M, Gilmer WS, Dresselhaus TR, Thase ME, Nierenberg AA, Trivedi MH, Rush AJ. Effect of age at onset on the course of major depressive disorder. Am J Psychiatry. 2007 Oct;164(10):1539-46. doi: 10.1176/appi.ajp.2007.06101757.
citation: Bridge JA, Birmaher B, Iyengar S, Barbe RP, Brent DA. Placebo response in randomized controlled trials of antidepressants for pediatric major depressive disorder. Am J Psychiatry. 2009 Jan;166(1):42-9. doi: 10.1176/appi.ajp.2008.08020247. Epub 2008 Dec 1.
citation: Gabbay V, Johnson AR, Alonso CM, Evans LK, Babb JS, Klein RG. Anhedonia, but not irritability, is associated with illness severity outcomes in adolescent major depression. J Child Adolesc Psychopharmacol. 2015 Apr;25(3):194-200. doi: 10.1089/cap.2014.0105. Epub 2015 Mar 24.
citation: Pizzagalli DA. Depression, stress, and anhedonia: toward a synthesis and integrated model. Annu Rev Clin Psychol. 2014;10:393-423. doi: 10.1146/annurev-clinpsy-050212-185606.
citation: Giedd JN. The teen brain: insights from neuroimaging. J Adolesc Health. 2008 Apr;42(4):335-43. doi: 10.1016/j.jadohealth.2008.01.007.
citation: Dunn BD. Helping depressed clients reconnect to positive emotion experience: current insights and future directions. Clin Psychol Psychother. 2012 Jul-Aug;19(4):326-40. doi: 10.1002/cpp.1799. Epub 2012 Jun 5.
citation: Holmes EA, Blackwell SE, Burnett Heyes S, Renner F, Raes F. Mental Imagery in Depression: Phenomenology, Potential Mechanisms, and Treatment Implications. Annu Rev Clin Psychol. 2016;12:249-80. doi: 10.1146/annurev-clinpsy-021815-092925. Epub 2016 Jan 15.
citation: Burnett Heyes S, Lau JY, Holmes EA. Mental imagery, emotion and psychopathology across child and adolescent development. Dev Cogn Neurosci. 2013 Jul;5:119-33. doi: 10.1016/j.dcn.2013.02.004. Epub 2013 Mar 5.
citation: Pile V, Lau JYF. Looking forward to the future: Impoverished vividness for positive prospective events characterises low mood in adolescence. J Affect Disord. 2018 Oct 1;238:269-276. doi: 10.1016/j.jad.2018.05.032. Epub 2018 May 30.
citation: Pile V, Smith P, Leamy M, Blackwell SE, Meiser-Stedman R, Stringer D, Ryan EG, Dunn BD, Holmes EA, Lau JYF. A brief early intervention for adolescent depression that targets emotional mental images and memories: protocol for a feasibility randomised controlled trial (IMAGINE trial). Pilot Feasibility Stud. 2018 Jul 4;4:97. doi: 10.1186/s40814-018-0287-3. eCollection 2018.
citation: Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.