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Effectiveness of Using the Progressive Goal Attainment Program in Anxiety and Mood Disorders (PGAP)

16 marzo 2020 aggiornato da: Tanja Colonerus, St. Joseph's Healthcare Hamilton

Effectiveness and Feasibility of Using the Progressive Goal Attainment Program in Anxiety and Mood Disorders

The purpose of the present study is to determine the effectiveness and feasibility of the Progressive Goal Attainment Program (PGAP) with individuals with anxiety and mood disorders. PGAP has been suggested as an effective therapy to reduce psychosocial barriers and help individuals return to life roles including readiness to return to work. PGAP has been shown to be effective with some chronic health conditions however has not been specifically studied in mental health populations. The study consists of 10 one hour weekly therapy sessions that focus on reducing psychosocial risk factors that result in disability through the use of goal setting, activity planning and activation, monitoring and challenging thoughts about return to work, and problem solving. Participants will also be asked to complete short self-report questionnaires as well as a semi-structured interview about the participants anxiety, mood, impact of disability, and current functioning at the beginning of session one and within two weeks after session 10. Two short questionnaires will also be completed at each session measuring the degree to which the participants daily life impacts and is affected by anxiety or mood symptoms.

Panoramica dello studio

Stato

Completato

Descrizione dettagliata

The purpose of the present study is to determine the effectiveness of the Progressive Goal Attainment Program (PGAP) with individuals with anxiety and mood disorders. PGAP has been suggested as an effective therapy to reduce psychosocial barriers and help individuals return to life roles including readiness to return to work. PGAP has been shown to be effective with some chronic health conditions however has not been specifically studied in mental health populations.

The study consists of 10 one hour weekly therapy sessions with a clinician and follow the PGAP manual. The therapy sessions focus on reducing psychosocial risk factors that result in disability through the use of goal setting, activity planning, activation and re-engagement in activities, monitoring and challenging thoughts about return to work, and problem solving. Participants are also encouraged to participate in homework which involves daily activity planning, participating in planned activities, and tracking the activities completed. Participants will also be asked to complete short self-report questionnaires as well as a semi-structured interview about the participants anxiety, mood, impact of disability, and current functioning at the beginning of session one and within two weeks after session 10. Two short questionnaires will also be completed at each session measuring the degree to which the participants daily life impacts and is affected by anxiety or mood symptoms.

Our first hypothesis is that participants who receive PGAP will report significant reductions in functional disability as measured by self-report as well as by interview, decreases in self-reported work avoidance, increases in work readiness, and decreases in self-reported symptoms of anxiety and depression. Our second hypothesis is that mean reductions in the above-noted outcome variables will be similar in magnitude to those reported in published studies that have examined PGAP in chronic medically ill populations. Retention rates and satisfaction of the therapy will also be assessed to determine feasibility of implementing the program on a larger scale.

To examine the effectiveness of PGAP with participants with an anxiety or a mood disorder, the investigators will conduct a series of dependent sample t-tests on the outcome variables pre and post intervention. The investigators will also compare mean changes on the outcome variables to those in the published literature. The investigators will calculate retention rates with the aim of retaining more than 75% of participants, which is comparable to retention and drop out rates for psychotherapy trials with participants completing at least 8 out of 10 sessions or having returned to employment. Feasibility will also be measured by looking at satisfaction ratings. A minimal standard will be an average satisfaction rating across participants of midpoint (neutral) or above in terms of the therapy received.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

43

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Ontario
      • Hamilton, Ontario, Canada, L8N 3K7
        • St. Joseph's Healthcare Hamilton

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

Participants will be

  1. between the ages of 18 and 65 years
  2. have a principle diagnosis of an anxiety or mood disorder
  3. have had changes in their work functioning, either currently not working due to their disability or on modified/reduced work.
  4. be registered outpatients of the Anxiety Treatment and Research Clinic or Outpatient Mood Disorders Program, St. Joseph's Healthcare Hamilton,
  5. are interested in return to work or have work related goals.

Exclusion Criteria:

  1. current significant substance use
  2. acute mental health (e.g. suicidality, psychosis, mania) that would interfere with the program completion

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Progressive Goal Attainment Program
10 one hour weekly therapy sessions focused on behavioural interventions
Behavioural intervention that consists of 10 one hour weekly therapy sessions that focus on goal setting, challenging thoughts about return to work, problem solving, behavioural activation, and resuming occupational roles.
Altri nomi:
  • PGAP

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Impact of PGAP on disability (participant perception)
Lasso di tempo: one year
Level of disability will be measured using a modified version of the Pain Disability Index ( a 7 item self-report measure).
one year

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Impact of PGAP on symptom change
Lasso di tempo: one year
Mood and anxiety symptoms will be measured using the Depression and Anxiety Stress Scales (a 21 item self-report measure).
one year
Impact of PGAP on level of interference from mood and anxiety symptoms
Lasso di tempo: one year
Level of interference from mood and anxiety symptoms will be measured using the Illness Intrusiveness Rating Scale (13 item self-report measure).
one year
Impact of PGAP on fear avoidance beliefs
Lasso di tempo: one year
Fear avoidance beliefs will be measured using the Fear Avoidance Beliefs Questionnaire (11 item self-report measure).
one year
PGAP retention rates
Lasso di tempo: one year
Retention rates will be measured by tracking drop out rates.
one year
Satisfaction with the PGAP
Lasso di tempo: one year
Satisfaction with the therapy will be assessed by using The Satisfaction with Therapy and Therapist Scale-Revised (13 item self-report measure).
one year
Impact of PGAP on disability (clinician report)
Lasso di tempo: one year
Level of disability will be measured using the Multidimensional Scale of Independent Functioning (semi-structured interview).
one year
Impact of PGAP on role functioning
Lasso di tempo: one year
Role functioning will be measured using the Multidimensional Scale of Independent Functioning (semi-structured interview).
one year

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Tanja Colonerus, MADS, St. Joseph's Healthcare Hamilton

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 novembre 2016

Completamento primario (Effettivo)

1 aprile 2019

Completamento dello studio (Effettivo)

1 aprile 2019

Date di iscrizione allo studio

Primo inviato

20 giugno 2016

Primo inviato che soddisfa i criteri di controllo qualità

28 giugno 2016

Primo Inserito (Stima)

30 giugno 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 marzo 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 marzo 2020

Ultimo verificato

1 marzo 2020

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1784 (Bern University Hospital)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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