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Cognitive behavioural therapy in primary health care for persistent physical symptoms

Evaluation of the clinical effectiveness and economic impact of a hybrid transdiagnostic cognitive behavioural treatment for persistent physical symptoms among adults seeking primary health care in Iceland: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN23526619
Enrollment
36
Registered
2021-08-03
Start date
2023-04-01
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Persistent physical symptoms accompanied by anxiety and/or depressive symptoms Signs and Symptoms

Interventions

Current intervention as of 11/10/2022: During recruitment, health care workers of participating primary health care clinic will refer patients to the study if there is a suspicion of persistent physic

Sponsors

Reykjavík University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 11/10/2022: 1. Referred to the study by primary care professionals between January 2022 and October 2022 2. Experience persistent physical symptoms that influence impairment in everyday life 3. Scoring above threshold on one of the following psychological measures: PHQ-9, GAD-7 or SHAI 4. Aged over 18 years of age 5. At assessment, say they will accept psychological treatment of their symptoms _____ Previous inclusion criteria: 1. Referred to VIRK for work rehabilitation between September 2021 and December 2022 2. Experience persistent physical symptoms which influence their workability 3. Scoring above threshold on one of the following psychological measures, PHQ-9, GAD-7 or SHAI 4. Over 18 years of age 5. At assessment, say they will accept psychological treatment of their symptoms

Exclusion criteria

Exclusion criteria: 1. Do not speak/read Icelandic 2. Serious physical or mental health problems that affect participation in treatment, e.g. current psychotic symptoms, active substance abuse

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure as of 11/10/2022: Impairment in mental health functioning in terms of work, home management, leisure and close relationships, measured with the Work and Social Adjustment Scale (WSAS) at baseline, after 4 weeks of treatment, after 8 weeks of treatment, and 3-month and 6-month follow-up _____ Previous primary outcome measure: Impairment in mental health functioning in terms of work, home management, leisure and close relationships, measured with the Work and Social Adjustment Scale (WSAS) at baseline, after 6 weeks of treatment, after 12 weeks of treatment, and 3-month and 6-month follow up

Secondary

MeasureTime frame
Current secondary outcome measures as of 11/10/2022: 1. Presence and severity of PPS, measured using The Persistent Physical Symptom Checklist (PPSC) at baseline, after 4 weeks of treatment, after 8 weeks of treatment, and 3-month and 6-month follow-up 2. Questionnaire measure of their identified main psychological problem: 2.1. Depression measured using Patient Health Questionnaire-9 (PHQ-9) at baseline, after 4 weeks of treatment, after 8 weeks of treatment, and 3-month and 6-month follow-up 2.2. General anxiety measured using General Anxiety Disorder-7 (GAD-7) at baseline, after 4 weeks of treatment, after 8 weeks of treatment, and 3-month and 6-month follow-up 2.3. Health anxiety measured using Short Health Anxiety Inventory (SHAI) at baseline, after 4 weeks of treatment, after 8 weeks of treatment, and 3-month and 6-month follow-up _____ Previous secondary outcome measures: 1. Presence and severity of PPS, measured using The Persistent Physical Symptom Checklist (PPSC) at baseline, after 6 weeks of treatment, after 12 weeks of treatment, and 3-month and 6-month follow up 2. Questionnaire measure of their identified main psychological problem: 2.1. Depression measured using Patient Health Questionnaire-9 (PHQ-9) at baseline, after 6 weeks of treatment, after 12 weeks of treatment, and 3-month and 6-month follow up 2.2. General anxiety measured using General Anxiety Disorder-7 (GAD-7) at baseline, after 6 weeks of treatment, after 12 weeks of treatment, and 3-month and 6-month follow up 2.3. Health anxiety measured using Short Health Anxiety Inventory (SHAI) at baseline, after 6 weeks of treatment, after 12 weeks of treatment, and 3-month and 6-month follow up

Countries

Iceland

Contacts

Public ContactElín Broddadótir
elinb@ru.is+354 (0)8491345

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026