Web-based ACT to Support Parents With Children With Chronic and Developmental Conditions

NCT04250012 | Completed

• 1 other identifier: 18/26/2018
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

Parents of children with a chronic disease or functional disabilities have an increased risk of stress-related distress and reduced quality of life. Internet-delivered interventions are one way to reach out to exhausted parents who may often have challenges in finding time to access face-to-face services. We developed a guided web-based Acceptance and Commitment Therapy intervention for Finnish parents of children with chronic conditions or functional disabilities. Participants (N=100) will be recruited on parent associations' Facebook groups and randomly assigned to guided web-based ACT condition and a control condition receiving psychoeducation. The guided web-based ACT condition will receive a 10-week web intervention including three remote meetings with a psychologist through the telemedicine application Doxy.me. Symptoms of burnout (SMBQ), depression (PHQ), health-related quality of life (RAND-36), mindfulness (FFMQ), general measure of psychological flexibility (CompACT) as well as the wellbeing of their child (KINDL) will be measured before (pre) and after the intervention (post), at 7-month (follow-up 1) and 10-month (follow-up 2) after the pre-measurement. In this randomized controlled trial we will investigate the outcomes and the mechanisms of change of the web-based ACTintervention. In addition, we will examine the acceptability of the web-based intervention.

Conditions

Burnout Syndrome; Psychological Distress; Depressive Symptoms; Quality of Life

Keywords

Parents, burnout, parental distress, Internet-based, ACT

Outcome Measures

Primary Outcomes (1)

• Burnout

  Burnout symptoms were measured with the Shirom-Melamed Burnout Questionnaire (SMBQ, Lundgren-Nilsson, Jonsdottir, Pallant, \& Ahlborg, 2012; Melamed et al., 1999; Shirom \& Melamed, 2006). The SMBQ measures four elements of burnout; Emotional exhaustion and physical fatigue, Listlessness, Tension, and Cognitive weariness. The SMBQ consists of 22 items that are rated on a seven-point scale ranging from 1 'Never or almost never' to 7 'Always or almost always'. High scores correspond to more burnout symptoms. The cut-off scores for burnout on the SMBQ are 2.75 - 3.74 indicating low burnout, 3,75 - 4,46 indicating high burnout and ≥ 4.47 indicating pathological level of burnout. SMBQ's psychometric characteristics and factorial validity have been supported (Lundgren-Nilsson et al., 2012; Shirom \& Melamed, 2006).

  Change from baseline at 3 months, 7 months and 10 months after the pre-measurement

Secondary Outcomes (5)

• Depression (PHQ-9)

  Change from baseline at 3 months, 7 months and 10 months after the pre-measurement

• Health-related quality of life (RAND-36) Health-related quality of life (RAND-36) Health-related quality of life (RAND-36)

  Change from baseline at 3 months, 7 months and 10 months after the pre-measurement

• Mindfulness (FFMQ)

  Change from baseline at 3 months, 7 months and 10 months after the pre-measurement

• Psychological flexibility and ACT-related processes (CompACT)

  Change from baseline at 3 months, 7 months and 10 months after the pre-measurement

• Health-related quality of life in children (KINDL)

  Change from baseline at 3 months, 7 months and 10 months after the pre-measurement

Study Arms (2)

Internet-based ACT intervention

EXPERIMENTAL

Group "Internet-based ACT intervention" will receive a 10-week internet-based acceptance and commitment therapy intervention with three remote meetings with a psychologist

Behavioral: Internet-based ACT intervention

Psychoeducation

ACTIVE COMPARATOR

Group "Psychoeducation" will receive a self-help booklet and a link to mobile wellness training program

Behavioral: Psychoeducation

Interventions

Internet-based ACT intervention BEHAVIORAL

The Internet-based ACT intervention included a 10-week web-based program consisting of five modules with different themes that the participants were instructed to process during the course of two weeks. The program was based on the processes of ACT and included themes such as life values, mindfulness, defusion, self-as-context acceptance and self-compassion. The content of each module consisted of text, video, exercises with audio files, and homework assignments. In addition, the participants filled in a diary with exercises in paper format. The intervention included also three remote meetings (à 45 minutes) via a videoconferencing tool doxy.me conducted by a psychologist. The remote meetings took place at the beginning, after 4 weeks, and at the end of the intervention.

Internet-based ACT intervention

Psychoeducation BEHAVIORAL

The psychoeducation group received a self-help booklet and a link to a web-based wellness training program. The program included exercises with MP3 audio files. No personal support during the 10-week intervention was provided.

Psychoeducation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The parent:
• has a child (aged 0-18 years) with a long-term illness or developmental disorder or disability,
• has symptoms of burnout based on the Shirom-Melamed Burnout questionnaire (SMBQ), i.e. at least 2.75 points.
• has access to computer and internet.

You may not qualify if:

• The parent:
• has an inadequate knowledge of the Finnish language (unable to fill in questionnaires or follow the program);
• has parallel regular psychological treatment or therapy
• has a severe mental disorder.

Sponsors & Collaborators

• University of Jyvaskyla: lead
• The Gerocenter Foundation for Research and Development: collaborator
• Social Insurance Institution, Finland: collaborator

Study Sites (1)

Department of Psychology, University of Jyväskylä

Jyväskylä, 40014, Finland

Location

MeSH Terms

Conditions

Burnout, Psychological; Depression

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Raimo Lappalainen, PhD

  Department of Psychology, University of Jyväskylä

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 31, 2020
• Study Start: January 28, 2019
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)