Mindfulness-based cognitive therapy to improve stress and reduce sleep in patients with inflammatory bowel disease

Mindfulness-based cognitive therapy to improve stress and reduce sleep in patients with inflammatory bowel disease - Mindfulness for IBD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49598

Enrollment

136

Registered

2021-04-20

Start date

2021-07-21

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colitis Ulcerosa Crohn's disease Inflammatory bowel disease

Interventions

The intervention group will receive Mindfulness-Based Cognitive Therapy (MBCT) in addition to treatment as usual (TAU). MBCT consists of 8 weekly sessions of 2,5 hours each, a silent day and home pr

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Confirmed IBD diagnosis of Crohn*s disease (CD), Ulcerative colitis (UC) or Indeterminate colitis (IC) Current IBD remission (Calprotectin

Exclusion criteria

Exclusion criteria: Severe psychiatric disorders (e.g. acute suicidality, psychosis) Current alcohol or drug dependency Untreated anemia Prior participation in an 8-week MBSR or MBCT-programme

Design outcomes

Primary

Measure	Time frame
Primary outcome will be psychological distress according to the Hospital Anxiety and Depression Scale (HADS).	—

Secondary

Measure	Time frame
Secondary outcomes will be: - Sleep quality/regularity (wearable sleep EEG: the iBand+ and the Fitbit activity tracker) and fatigue (FACIT-F). - IBD-specific secondary outcomes will be IBD-related quality of life (IBDQ), perceived control over IBD (IBD-control questionnaire). - Clinical secondary outcomes will be fecal calprotectin, c-reactive protein levels (both assessed in accordance with regular medical procedures), clinical disease activity (Harvey Bradaw Index for CD, the Simple Clinical Colitis Activity Index for UC), and relapse into IBD-related flares. - General secondary outcomes will be repetitive negative thinking (PTQ) , mindfulness skills (FFMQ-SF), self-compassion skills (SCS-SF), and positive mental health (MHC-SF). - Costs (TIC-P) and utilities (EQ-5D-5L) will be investigated to explore cost-effectiveness. Lastly, qualitative interviews which focus on usefulness and feasibility of MBCT will be performed.	—

Measure

Time frame

Secondary outcomes will be: - Sleep quality/regularity (wearable sleep EEG: the iBand+ and the Fitbit activity tracker) and fatigue (FACIT-F). - IBD-specific secondary outcomes will be IBD-related quality of life (IBDQ), perceived control over IBD (IBD-control questionnaire). - Clinical secondary outcomes will be fecal calprotectin, c-reactive protein levels (both assessed in accordance with regular medical procedures), clinical disease activity (Harvey Bradaw Index for CD, the Simple Clinical Colitis Activity Index for UC), and relapse into IBD-related flares. - General secondary outcomes will be repetitive negative thinking (PTQ) , mindfulness skills (FFMQ-SF), self-compassion skills (SCS-SF), and positive mental health (MHC-SF). - Costs (TIC-P) and utilities (EQ-5D-5L) will be investigated to explore cost-effectiveness. Lastly, qualitative interviews which focus on usefulness and feasibility of MBCT will be performed.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)