Imagine a Brighter Future: An Intervention to Improve Positive Emotions in Young People

NCT05507385 | Withdrawn

• 1 other identifier: IMAGINE-POSITIVE
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Depression; Anhedonia

Keywords

Adolescence; Depression; Anhedonia; Mental Imagery

Outcome Measures

Primary Outcomes (17)

• Feasibility outcome - 1: Uptake by schools

  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.

  Through study completion, an average of 9 months

• Feasibility outcome - 2: Uptake by participants

  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

  Through study completion, an average of 9 months

• Feasibility outcome - 3: Intervention completion

  The number of participants successfully completing the intervention

  Through study completion, an average of 9 months

• Feasibility outcome - 4: Intervention drop-out

  The number of participants that drop-out and the reasons for dropping out

  Through study completion, an average of 9 months

• Feasibility outcome - 5: Time Period

  Time needed to collect and analyse data

  Through study completion, an average of 9 months

• Feasibility outcome - 6: Data completeness at pre-assessment

  Data completeness for each questionnaire at pre-assessment

  Through study completion, an average of 9 months

• Feasibility outcome - 7: Missing Data at pre-assessment

  Data missing and reasons for missing data at pre-assessment

  Through study completion, an average of 9 months

• Feasibility outcome - 8: Data completeness at post-assessment

  Data completeness for each questionnaire at post-assessment

  Through study completion, an average of 9 months

• Feasibility outcome - 9: Missing Data at post-assessment

  Data missing and reasons for missing data at post-assessment

  Through study completion, an average of 9 months

• Feasibility outcome - 10: Data completeness at follow-up assessment

  Data completeness for each questionnaire at follow-up assessment

  Through study completion, an average of 9 months

• Feasibility outcome - 11: Missing Data at follow-up assessment

  Data missing and reasons for missing data at follow-up assessment

  Through study completion, an average of 9 months

• Feasibility outcome - 12: Unexpected adverse effects

  The number and nature of unexpected adverse effects will be recorded

  Through study completion, an average of 9 months

• Acceptability of the intervention - 1: Open questions for qualitative feedback of the programme

  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?

  Post-intervention (within 2 weeks of post intervention)

• Acceptability of the intervention - 2: Satisfaction with the programme

  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.

  Post-intervention (within 2 weeks of post intervention)

• Acceptability of the intervention - 3: Feedback on the number of sessions in the programme

  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.

  Post-intervention (within 2 weeks of post intervention)

• Acceptability of the intervention - 4: Extend the programme has helped

  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.

  Post-intervention (within 2 weeks of post intervention)

• Acceptability of the intervention - 5: Recommend the programme to a friend

  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.

  Post-intervention (within 2 weeks of post intervention)

Secondary Outcomes (10)

• 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

Study Arms (2)

Intervention: IMAGINE-P

EXPERIMENTAL

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).

Behavioral: IMAGINE-POSITIVE

Control:

ACTIVE COMPARATOR

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.

Behavioral: Control

Interventions

IMAGINE-POSITIVE BEHAVIORAL

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), to increase vividness and savouring of positive future images, in order to harness positive affect. IMAGINE-PA will follow a treatment manual and delivery will be accompanied by a therapy workbook.

Intervention: IMAGINE-P

Control BEHAVIORAL

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.

Control:

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 14-19
• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• King's College London: lead
• Mental Health Research UK: collaborator

Study Sites (1)

King's College London

London, SE5 8AB, United Kingdom

Location

Related Publications (11)

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• 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.

  PMID: 19047322 BACKGROUND

• 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.

  PMID: 25802984 BACKGROUND

• 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.

  PMID: 24471371 BACKGROUND

• 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.

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• 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.

  PMID: 22674611 BACKGROUND

• 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.

  PMID: 26772205 BACKGROUND

• 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.

  PMID: 23523985 BACKGROUND

• 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.

  PMID: 29894932 BACKGROUND

• 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.

  PMID: 29997904 BACKGROUND

• 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.

  PMID: 15189396 BACKGROUND

MeSH Terms

Conditions

Depression; Anhedonia

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Model Details: Eligible participants will be randomised to an intervention group or the control group.

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: August 19, 2022
• Study Start: September 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 9, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)