MedPath

Recovery in Telling Life Stories

Not Applicable
Recruiting
Conditions
Schizophrenia Disorders
Personality Disorders
Obsessive - Compulsive Disorder
Anxiety Disorders
PTSD - Post Traumatic Stress Disorder
Recurrent Depressive Disorder
Hyperkinetic Disorders
Eating Disorders
Bipolar Disorders
Aspergers Syndrome
Registration Number
NCT07082777
Lead Sponsor
University of Aarhus
Brief Summary

This project tests the Recovery In Telling Life Stories (RETELL) intervention, aimed at supporting personal recovery in people with severe mental illness (SMI). While many of those with SMI experience symptom control, their quality of life often remains low due to social loss, negative self-perceptions, and identity-related challenges not addressed by standard treatments. Through a process of narrative repair, the RETELL intervention helps participants explore the personal consequences of mental illness while supporting the enhancement of narratives that strengthen identity and foster well-being. The intervention is delivered across 8-12 sessions and will be assessed for feasibility of both the intervention and study procedures. We will also explore its preliminary impact on recovery, quality of life, symptoms, functioning, self-stigma, and personality, using a multiple single-case A-B-A design. We expect the intervention and study procedures to show acceptable feasibility. We further hypothesize that participants' scores on recovery and well-being will be low at baseline, improve during the intervention, and remain higher after the intervention ends and at 3-month follow-up. This study will provide a foundation for future randomized controlled trials.

Detailed Description

This project tests the Recovery In Telling Life Stories (RETELL) intervention, an intervention developed to support personal recovery in individuals with severe mental illness (SMI).

Research shows that many people with SMI experience low quality of life even when their symptoms are in remission and functional level, e.g. cognitive remediation. This is not only due to the illness itself but also to the consequences that often accompany it, such as the loss of social and occupational roles and the development of negative self-perceptions. These challenges are only to a limited extent addressed by existing treatments, which typically focus on symptom reduction.

Personal recovery is about living a satisfying and meaningful life despite the potential constraints associated with mental illness. A major barrier to this process can arise when a person develops an understanding of themself (a narrative identity) characterized by shame, low self-esteem, and self-stigmatization. When negative identity conclusions dominate, it can be difficult to experience well-being, meaning in life, or hope for the future.

Despite an increasing focus on personal recovery in mental health care systems globally, evidence-based methods to support the recovery process are limited. In this project, we develop and test the RETELL intervention, designed to support personal recovery by helping participants process the personal consequences of mental illness and identify and cultivate positive identity conclusions and personal strengths. In RETELL, the participants are guided through this process, which we refer to as narrative repair, over a structured sequence of 8-12 sessions. Across these sessions, participants are guided in telling their life story and in constructing preferred and empowering narratives about themselves and their future.

The intervention will be tested in a mixed methods study using a one-arm multiple single-case intervention design with an A-B-A structure. This includes a pre-intervention phase (T1) with four weeks of outcome measurements, an intervention phase (T2) continuing with the same measures every second week, 4 weeks of post-intervention measurements (T3), and 4 weeks of follow-up measurements starting 3 months after intervention completion (T4). Data will be collected in electronic surveys and qualitative interviews. The primary aim is to assess intervention feasibility including potential to improve recovery and quality of life. It is aimed to recruit 20 participants diagnosed with SMI within the timeframe allowed by the study plan.

Feasibility will be assessed in terms of both intervention and study procedure feasibility, as this study will form the basis for larger randomized controlled trials. Intervention feasibility will be evaluated based on treatment dropout, treatment satisfaction and trajectory of self-reported recovery compared to pre-intervention. Feasibility will be indicated by \< 30% dropout, a mean sum score of ≥ 20 on the Client Satisfaction Questionnaire, and increase or stability of self-reported recovery throughout the study period compared to pre-intervention. Study procedure feasibility includes recruitment acceptance rate, questionnaire response rate and study dropout rate. We tentatively propose a ≥ 50% recruitment acceptance rate, ≥ 75% questionnaire response rate and ≤ 25% study dropout rate as indicating acceptable study feasibility.

Secondary outcomes include well-being, domain-specific recovery, overall functioning, symptom levels, and self-stigmatization. In addition, changes from pre- to post-intervention in personality trait scores will be explored. Statistical analyses will include dependent t-tests to examine effect sizes and changes in quantitative outcomes, and these will be interpreted with attention to clinical significance. Finally, interviews about participants' experiences with the intervention will be thematically analyzed to identify perceived helpful elements, potential mechanisms of change and to inform the refinement of the programme theory.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
20
Inclusion Criteria
  • Adults between the ages of 18 and 65 years
  • A self-reported principal diagnosis of one or more of the following: schizophrenia (F20), bipolar disorder (F31), personality disorders (F60), obsessive-compulsive disorder (F42), anxiety disorders (F41), recurrent depressive disorder (F33), eating disorders (F50), hyperkinetic disorders (F90), post-traumatic stress disorder (F43.1), Asperger syndrome (F84.5)
  • Not in full recovery (Brief INSPIRE-O < 50)
  • Danish language proficiency
  • Medication stabilized (i.e., same type and dosage for a minimum of 8 weeks)
  • Ability and willingness to give informed consent
Exclusion Criteria
  • Self-reported diagnosis of mental retardation (F70-79) and/or organic mental disorder (F00-09)
  • Psychiatric symptoms, thoughts of self-harm and/or substance abuse of self-reported severity which are likely to prevent one or all of the following: attendance at scheduled sessions, completion of questionnaires before, during and after the intervention, meaningful engagement in the therapeutic process
  • Psychiatric hospitalization in the past 4 weeks
  • Prior conviction of violent crime
  • Currently homeless
  • Currently in psychotherapy initiated within the past 6 months.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Intervention feasibility: Change from pre-intervention throughout the intervention to post-intervention and follow-up in personal recoveryPre-intervention (T1), intervention (T2), post-intervention (T3) and follow-up (T4)

Recovery will be assessed using the Brief INSPIRE-O, consisting of 5 items reflecting five dimensions of personal recovery: connectedness with others, hope and optimism for the future, positive identity, meaning in life, and empowerment, with a score range of 0-100. Feasibility will be indicated by stability or increase throughout the study period compared to pre-intervention.

Intervention feasibility: Satisfaction with treatment (quantitative)Post-intervention (T3)

Participant-reported treatment satisfaction using the using the Client Satisfaction Questionnaire (CSQ), a brief, standardized self-report measure designed to assess clients' overall satisfaction with healthcare or psychological services. It consists of 8 items rated on a Likert scale, covering aspects such as service quality, perceived helpfulness, and whether the service met the client's needs. Total score range: 8-32, with higher numbers indicating greater satisfaction. Feasibility will be indicated by a mean score of 20 or above.

Intervention feasibility: Treatment dropout rateThrough intervention phase (T2), between 8-12 weeks

Treatment dropout is defined as participation in less than three out of the four therapeutic tasks of the intervention. Feasibility will be indicated by a dropout rate \< 30%.

Secondary Outcome Measures
NameTimeMethod
Change from pre-intervention to post-intervention and follow-up in functioning and disabilityPre-intervention (T1), post-intervention (T3) and follow-up (T4)

Functioning and disability will be assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS) 12-item version, a brief, standardized self-report instrument developed to assess difficulties in daily functioning across the past 30 days. Responses are scored on a 5 point Likert scale: None (0), Mild (1), Moderate (2), Severe (3), and Extreme/Cannot Do (4).

Study procedure feasibility: Study drop-out rateThroughout study completion, an average of approximately 35 weeks.

Rate of nonresponse to any complete batch of questionnaires during intervention phase, at postintervention or follow-up

Intervention feasibility: Satisfaction with the therapeutic allianceIntervention phase (T2)

Participant-reported quality of the therapeutic alliance using the Session Rating Scale (SRS), a visual analogue scale (ranging from 0 to 10) that allows individuals to provide feedback on key aspects of the session, such as the therapeutic alliance and overall experience.

Change from pre-intervention to post-intervention and follow-up in domain-specific recoveryPre-intervention (T1), post-intervention (T3) and follow-up (T4)

Domain-specific recovery will be assessed using the Recovery Assessment Scale-Domains and Stages (RAS-DS), a self-report measure designed to capture an individual's subjective experience of recovery across multiple life domains. The scale assesses four key domains: Doing Things I Value, Looking Forward, Mastering My Illness, and Connecting and Belonging, each reflecting different aspects of personal recovery. Items are rated on a 4-point Likert scale, ranging from 1 (Untrue) to 4 (Completely true). The total scale score ranges from 38-152, with higher scores indicating greater perceived recovery. The RAS-DS is grounded in a consumer-oriented understanding of recovery and has demonstrated good psychometric properties across various mental health populations.

Study procedure feasibility: Acceptance rateStudy recruitment phase, approximately 15 months

The proportion of participants enrolled from the number of individuals who received oral and written information about the study from the study coordinator, and were found to be eligble during screening.

Study procedure feasibility: Questionnaire response rateThroughout study completion, an average of approximately 35 weeks.

The average percentage of questionnaires completed within each batch (e.g., T1) and overall (T1-T4).

Change from pre-intervention to post-intervention and follow-up in symptomatic statusPre-intervention (T1), post-intervention (T3) and follow-up (T4)

Symptomatic status will be assessed using the DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure for Adults, a standardized screening tool to assess a broad range of psychiatric symptoms across multiple diagnostic domains. The measure includes 23 items covering 13 symptom domains (e.g., depression, anxiety, psychosis, sleep problems, and substance use), each rated on a 5-point scale from 0 (none) to 4 (severe), reflecting symptom severity over the past two weeks.

Intervention feasibility: Number of participants with treatment-related adverse eventsFrom the beginning of the intervention (T2) to the final 3-month follow-up (T4)

Self-reported adverse events will be monitored during the intervention phase (T2) by systematic inquiry to hospitalization, thoughts of self-harm and suicide attempts, as well as at follow-up points (T3 and T4) by use of the DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure for Adults. Participants will also have the opportunity to anonymously report adverse events to a project staff member.

Intervention feasibility: Satisfaction with treatment (qualitative)Post-intervention (T3)

Participant-reported treatment satisfaction in qualitative, semi-structured interviews

Change from pre-intervention throughout the intervention to post-intervention and follow-up in well-beingPre-intervention (T1), intervention (T2), post-intervention (T3) and follow-up (T4)

Well-being will be assessed using the 5-item World Health Organization's Well-Being Index (WHO-5), designed to measure subjective well-being. Score range: 0-100.

Change from pre-intervention to post-intervention and follow-up in self-stigmatizationPre-intervention (T1), post-intervention (T3) and follow-up (T4)

Self-stigmatization will be assessed using the 10-item version of the Internalized Stigma of Mental Illness Scale (ISMI), a brief, validated self-report measure used to assess the degree to which individuals internalize negative beliefs and stereotypes about mental illness across the following subscales: Alienation, Discrimination Experience, Social Withdrawal, Stereotype Endorsement, and Stigma Resistance. Responses are a 4-point Likert scale ranging from strongly disagree (1) to strongly agree (4) for a total score range of 10 to 40, with higher scores representing more severe internalized stigmatization.

Change from pre-intervention to follow-up in Big 5 personality traitsPre-intervention (T1) and post-intervention (T3)

Big 5 personality traits will be assessed using the Big Five Inventory-2-S (BFI-2-S), a 30-item short form of the BFI-2 designed to measure the five broad personality domains: Extraversion, Agreeableness, Conscientiousness Neuroticism, and Openness to Experience. Each trait is assessed with 6 items rated on a 5-point Likert scale ranging from 1 (disagree strongly) to 5 (agree strongly).

Trial Locations

Locations (1)

Aarhus Univerity

🇩🇰

Aarhus C, Denmark

Aarhus Univerity
🇩🇰Aarhus C, Denmark
Dinne S. Christensen, PhD
Contact
004522317461
dsc@psy.au.dk

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