Internet-based Support for Adjustment to Prostate Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorLinkoeping University

About this trial

The study aims to study the efficacy of internet-based cognitive behavior therapy (ICBT) in reducing subjective distress and comorbid psychiatric symptoms in men diagnosed with prostate cancer. Participants who have been diagnosed with prostate cancer and are currently not undergoing or scheduled to undergo medical treatment will be recruited. Once recruited, they will be randomized to receive either a tailored, eight-week long ICBT intervention or an attention control group. Both group receive weekly support by a trained therapist.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjectively reported psychological symptoms and problems that have come about after a prostate cancer diagnosis.

A sum score above 19 on the primary outcome measure (Kessler-10).

An age of 18 or older.

Ability to speak, read, and write Swedish.

Disqualifiers

Planned medical treatment or planned change in medication related to the prostate cancer during the treatment period.

Recently finished (within the past six months) medical treatment for prostate cancer.

Severe psychiatric or somatic conditions that impedes participation in the study.

Ongoing substance use problems.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Internet-based cognitive behavioral therapy

    Behavioral

    An eight week ICBT treatment. The treatment is modular and tailored to the problem profile of the participant. One module will be administered every week during the treatment phase.

  • Non-directive support

    Behavioral

    Participants randomized to this condition will receive weekly support and contact with a therapist via the treatment platform. They will not have access to the treatment modules during the treatment phase.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Tailored ICBTExperimental treatment 1 intervention
Group B: Non-directive supportActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Kessler-10 (K10)

Measure of psychological distress. Consists of 10 items. Higher scores indicate greater psychological distress. Scores can range between 10 and 50.

Time frame
At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.

Secondary outcomes

1

Fear of Cancer Recurrence Inventory, short form (FCRI)

Measure of fear of the cancer recurring and/or spreading. Consists of 9 items. Higher scores indicate greater fear/anxiety levels. Scores can range between 0 and 36.

Time frame
At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
2

Generalized Anxiety Disorder-7 item scale (GAD-7)

Measure of symptoms of generalized anxiety disorder. Consists of seven items. Higher scores indicate greater anxiety. Scores can range between 0 and 21.

Time frame
At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
3

Insomnia Severity Index (ISI)

Measure of insomnia and sleep related-difficulties. Consists of seven items. Higher scores indicate greater sleep related-difficulties. Scores can range from 0 to 28.

Time frame
At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
4

Brunnsviken Brief Quality of Life Scale (BBQ)

Measure of quality of life. Consists of 12 items. Higher scores indicate a greater quality of life. Scores can range between 0 and 96.

Time frame
At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.

Other outcomes

1

Client Satisfaction Questionnaire-8 item version (CSQ-8)

Measure of treatment satisfaction. Consists of eight items. Higher scores indicate greater treatment satisfaction. Scores can range between 8 and 32.

Time frame
Measured after nine weeks of treatment.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Linkoeping University

Lead sponsor

University Hospital, Linkoeping

Collaborator