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

16. marts 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

43

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andre navne:
  • PGAP

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Impact of PGAP on disability (participant perception)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Impact of PGAP on symptom change
Tidsramme: 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
Tidsramme: 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
Tidsramme: one year
Fear avoidance beliefs will be measured using the Fear Avoidance Beliefs Questionnaire (11 item self-report measure).
one year
PGAP retention rates
Tidsramme: one year
Retention rates will be measured by tracking drop out rates.
one year
Satisfaction with the PGAP
Tidsramme: 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)
Tidsramme: 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
Tidsramme: one year
Role functioning will be measured using the Multidimensional Scale of Independent Functioning (semi-structured interview).
one year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Tanja Colonerus, MADS, St. Joseph's Healthcare Hamilton

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. november 2016

Primær færdiggørelse (Faktiske)

1. april 2019

Studieafslutning (Faktiske)

1. april 2019

Datoer for studieregistrering

Først indsendt

20. juni 2016

Først indsendt, der opfyldte QC-kriterier

28. juni 2016

Først opslået (Skøn)

30. juni 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1784 (Bern University Hospital)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Progressive Goal Attainment Program

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