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

16 de março de 2020 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Real)

43

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Outros nomes:
  • PGAP

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Impact of PGAP on disability (participant perception)
Prazo: 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

Medidas de resultados secundários

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Tanja Colonerus, MADS, St. Joseph's Healthcare Hamilton

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

16 de novembro de 2016

Conclusão Primária (Real)

1 de abril de 2019

Conclusão do estudo (Real)

1 de abril de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

20 de junho de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de junho de 2016

Primeira postagem (Estimativa)

30 de junho de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de março de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de março de 2020

Última verificação

1 de março de 2020

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 1784 (Bern University Hospital)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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