A comparison of brief and standard cognitive behavioural therapy (CBT) for patients in palliative care

A comparison of brief cognitive behavioural therapy (CBT) and standard CBT in patients experiencing anxiety and depression in palliative care: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN27496229

Enrollment

Registered

2011-01-13

Start date

2010-11-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Anxiety and depression in patients with a range of cancers Cancer Depressive episode

Interventions

The standard CBT arm comprises 7 sessions of CBT, plus further sessions if necessary as specified in the CBT clinic operational policy. The brief CBT arm comprises 3 sessions combining assessment and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients (greater than or equal to 18 years) with ongoing and persistent distress/emotional problems (as measured by a Hospital Anxiety and Depression Scale [HADS] score of 8 or more on anxiety or depression) which are directly related to some aspect of the patient's disease/treatment and are not responding to the existing provision of psychological care within the hospice system. This includes: 1. Difficulties making treatment decisions or difficulties adhering to treatment 2. Anticipatory symptoms (e.g. nausea and vomiting) 3. Phobias that are interfering with treatment (e.g. needle or blood phobia) 4. Extreme emotion which appears to be disproportionate to reality 5. Post traumatic symptoms (flashbacks) 6. Body image issues, disfigurement or loss of function 7. Psychosexual problems 8. Extreme fears about the terminal stage of illness 9. Rigid thinking styles (all or nothing, overgeneralisation etc.)

Exclusion criteria

Exclusion criteria: 1. Those who do not wish to have CBT 2. Psychosis or personality disorder 3. Very high suicide risk (psychiatric assessment required) 4. Moderate to severe drug and alcohol related problems 5. Patients already receiving psychological therapy or counselling 6. Patients who are not well enough to attend an outpatient clinic (e.g. unable to stay alert/awake for 50 mins, uncontrolled vomiting etc..) 7. Language or communication problems which prevent the patient from engaging in a talking treatment

Design outcomes

Primary

Measure	Time frame
Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983): This is a 14-item measure of mood designed for use with patients with physical illness. Seven items measure anxiety and seven depression. Its psychometric properties have been investigated in cancer patients, and it has been used successfully in previous trials in cancer patients. All outcomes will be assessed at baseline, session 3, then at 10 and 16 weeks.	—

Measure

Time frame

Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983): This is a 14-item measure of mood designed for use with patients with physical illness. Seven items measure anxiety and seven depression. Its psychometric properties have been investigated in cancer patients, and it has been used successfully in previous trials in cancer patients. All outcomes will be assessed at baseline, session 3, then at 10 and 16 weeks.

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Secondary

Measure	Time frame
1. Impact of Event Scale - Revised (Horowitz 1979, Weiss & Marmar 1997, Mystakidou 2007): This scale measures symptoms of intrusions and avoidance. A version developed by AJ Mitchell with specific reference to cancer will be used in this study 2. Brief COPE (Carver 1997): This is a 28-item questionnaire that assesses 14 different ways people respond to stress. 3. Sense of Coherence Scale (Antonovsky 1987): This scale measures 3 elements hypothesised to keep people well in the face of adversity: the ability to understand what is happening (comprehensibility), the ability manage the situation alone or with the help of a social network (manageability) and the ability to find meaning in the situation (meaningfulness). 4. Quality of Life Visual Analogue Scale: Patients are asked to mark on a line how much they are distressed by the following symptoms: nausea, tiredness, pain and appetite problems. 5. The Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Oken et al. 1982): The ECOG performance score has been used extensively in oncology research and is one of the most widely accepted measures of functional performance. The score ranges from 0 (fully active, able to carry on all pre-disease performance without restriction) to 5 (dead). At the mid-point, 3, the patient is capable of only limited self-care, confined to bed or chair for more than 50% of waking hours. 6. Cognitive Therapy First Aid Rating Scale (CFARS: Mannix et al 2006): This is a validated measure of therapist competency and adherence. All outcomes will be assessed at baseline, session 3, then at 10 and 16 weeks.	—

Measure

Time frame

1. Impact of Event Scale - Revised (Horowitz 1979, Weiss & Marmar 1997, Mystakidou 2007): This scale measures symptoms of intrusions and avoidance. A version developed by AJ Mitchell with specific reference to cancer will be used in this study 2. Brief COPE (Carver 1997): This is a 28-item questionnaire that assesses 14 different ways people respond to stress. 3. Sense of Coherence Scale (Antonovsky 1987): This scale measures 3 elements hypothesised to keep people well in the face of adversity: the ability to understand what is happening (comprehensibility), the ability manage the situation alone or with the help of a social network (manageability) and the ability to find meaning in the situation (meaningfulness). 4. Quality of Life Visual Analogue Scale: Patients are asked to mark on a line how much they are distressed by the following symptoms: nausea, tiredness, pain and appetite problems. 5. The Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Oken et al. 1982): The ECOG performance score has been used extensively in oncology research and is one of the most widely accepted measures of functional performance. The score ranges from 0 (fully active, able to carry on all pre-disease performance without restriction) to 5 (dead). At the mid-point, 3, the patient is capable of only limited self-care, confined to bed or chair for more than 50% of waking hours. 6. Cognitive Therapy First Aid Rating Scale (CFARS: Mannix et al 2006): This is a validated measure of therapist competency and adherence. All outcomes will be assessed at baseline, session 3, then at 10 and 16 weeks.

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Countries

United Kingdom

Outcome results

None listed

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