Enhancing One's Sense of Self Using Self-Affirmation

NCT03849924 | Completed

• 1 other identifier: NHS001384
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates whether a brief psychological intervention, known as a self-affirmation intervention which works by allowing one to recognise their own value, can improve well-being. This study also evaluates whether more of these interventions will lead to greater increases in well-being, and also measures self-esteem and anxiety to examine their potential involvement in the self-affirmation process. Participants are randomly assigned to either a self-affirmation intervention group, a 'booster' self-affirmation group whereby they receive the intervention twice, or a control group (no intervention). Participant's well-being, self-esteem and anxiety are assessed at baseline (before the intervention), 1 week, and 2 weeks after the intervention. It is hypothesised that those who undergo self-affirmation will have more improved levels of well-being than those who do not; those who undergo the self-affirmation twice will have the most improved levels of well-being. It is also hypothesised that self-esteem and state anxiety will be involved in the self-affirmation process and potentially mediate the effects of self-affirmation on well-being.

Conditions

Mental Health Wellness 1; Anxiety; Self Esteem

Keywords

well-being; randomised controlled trial; intervention

Outcome Measures

Primary Outcomes (1)

• Change from baseline subjective well-being at 2-weeks follow up

  This questionnaire assesses the three main components of subjective well-being, using the four items advised by the UK Office for National Statistics. These subjective well-being components include evaluation ("Overall, how satisfied are you with your life nowadays?"), experience ("Overall, how happy did you feel yesterday?" and "Overall, how anxious did you feel yesterday?") and eudemonic ("Overall, to what extend do you feel the things you do in your life are worthwhile?"). Participants were asked to respond to questionnaire items on 11-point Likert-type scales from 'not at all' (0) to 'completely' (10).

  Through study completion, up to 2 weeks

Secondary Outcomes (3)

• Change from baseline self-esteem at 2-weeks follow up

  Through study completion, up to 2 weeks

• Change from baseline self-esteem domains at 2-weeks follow up

  Through study completion, up to 2 weeks

• Change from baseline state anxiety at 2-weeks follow up

  Through study completion, up to 2 weeks

Study Arms (3)

Self-affirmation

EXPERIMENTAL

Participants assigned to the self-affirmation intervention condition will undergo a self-affirmation intervention in the form of a questionnaire at time point one (one week after the intervention). This is a brief intervention that involves forming self-affirming implementation intentions. Implementation intentions are formulated plans that encourage one to link critical situations with appropriate behavioural responses. In this study participants are encouraged to write out the stem and their response to the stem from the four options.

Behavioral: Self-affirmation

Self-affirmation 'booster'

EXPERIMENTAL

Participants assigned to this condition will undergo the self-affirmation intervention described above twice, in comparison to just once, in the form of a questionnaire at time points one (one week after the intervention) and two (two weeks after the intervention).

Behavioral: Self-affirmation

Control

NO INTERVENTION

Participants assigned to the control condition will not undergo a self-affirmation intervention. Instead they will still complete the same questionnaire as participants in the intervention conditions but without the self-affirmation intervention included (normally included on the last page of the questionnaire).

Interventions

Self-affirmation BEHAVIORAL

Self-affirmation implementation intentions in the form of a questionnaire.

Self-affirmation; Self-affirmation 'booster'

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Anyone that attends the NHS college designed to improve health and well-being that is willing to participate in the study

You may not qualify if:

• Any cognitive/psychological deficits that would affect the individual's capacity to consent

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Pennine Care NHS Foundation Trust- The Health and Well-being College

Manchester, Greater Manchester, OL6 7SR, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Charlotte S Entwistle, MRes

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The questionnaire administrator/investigator and participants are blind to the condition, as participants are not informed of the questionnaires being different from one another, and participants should return their questionnaires in sealed envelopes.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Participants are randomly assigned to an intervention group, intervention 'booster' group (receive the intervention twice) or a control group via a web-based randomiser.

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 21, 2019
• Study Start: September 3, 2018
• Primary Completion: September 28, 2018
• Study Completion: September 28, 2018
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)